Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

Brief Title

Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

Official Title

Sustainable-psycho-nutritional Intervention Program and Its Effects on Water and Carbon Footprint, Metabolic Biomarkers, and Gut Microbiota in Mexican Population: a m-Health Randomized Clinical Trial

Brief Summary

      Mexico is going through a major environmental and nutritional crisis, which is related to
      unsustainable dietary behaviors. Sustainable diets could solve both problems together.
      However, in Mexico and the world, an intervention program oriented to promoting sustainable
      diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks,
      sustainable-psycho-nutritional digital intervention program whose objective is to promote the
      adherence of the Mexican population to a sustainable diet and to evaluate its effects on
      dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this
      population. The behavior change wheel model and the guide for digital interventions design
      will be followed. In stage 1, the program will be designed using the sustainable diets model,
      and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food
      plans as well as a mobile application will be developed. In stage 2, the intervention will be
      carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young
      adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control
      group (n=50). The nutritional care process model will be used. Anthropometric, biochemical,
      clinical, dietary, environmental, socioeconomic level and cultural aspects,
      nutritional-sustainable knowledge, behavioral aspects, and physical activity will be
      considered. Thirteen behavioral objectives will be included using successive approaches in
      online workshops twice a week. The population will be monitored using the mobile application
      that will include behavioral change techniques. In stage 3, the effects of the intervention
      will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and
      gut microbiota composition of the evaluated population. It is expected to find improvements
      in health outcomes and a decrease in dietary water and carbon footprints. With this study,
      the first theoretical-methodological approach to the sustainable-psycho-nutrition approach
      will be generated.
    

Detailed Description

      1. Introduction:

           The change from the traditional Mexican diet to a Western diet, generated by the
           nutritional transition, has not only generated a prevalence of more than 75% of
           metabolic alterations (obesity, type 2 diabetes, cardiovascular diseases, dyslipidemia)
           and in the gut microbiota of the Mexican population, but it has also generated the water
           and carbon footprint of their diet to be the highest in the world with more than 8,000
           Liters per person per day (L p-1d-1) and 6.01 Kg CO2eq p-1d-1, respectively. This is
           linked to the aggravation of climate change, with increases of more than 1.0 ºC in the
           average atmospheric temperatures and the current water crisis that Mexico is going
           through, which affects 85% of the territory and has been referred to as the worst water
           drought in history, affecting the water supply of millions of Mexicans.

           One of the proposals for the joint solution of these problems has been the adoption of
           sustainable and territorial diets, which in Mexico could be carried out through the
           recovery of its traditional diet, both pre-Hispanic and colonized, which, prepared with
           low-fat culinary techniques and low content of animal products, can be considered as an
           appropriate option from a nutritional, cultural, economic and environmental perspective,
           dimensions that must be present for a diet to be considered as sustainable.

           However, to achieve the adoption of a particular diet, it is necessary to modify the
           eating behavior of the population. To modify both dietary and unsustainable behaviors in
           a population, there are multiple strategies, among which intervention programs have
           stood out. However, to date and both nationally and internationally, no intervention
           program whose objective is to promote both adequate nutrition to improve health and
           reduce the environmental impact of dietary behaviors, has been reported. This respecting
           cultural, social, economic, and psychological aspects of the population.

           Based on the above, this study protocol aims to design a three-stage 15 weeks
           intervention program, based on the guide to designing interventions of the behavior
           change wheel model, which includes both nutritional and sustainability elements, in the
           sense of considering unsustainable dietary behaviors of the Mexican population, in
           addition to taking into account their social, cultural and economic aspects. In addition
           to these axes, the basis of behavioral modification intervention programs is psychology.
           Therefore, it is proposed to design a sustainable-psycho-nutritional intervention
           program, whose objective is to promote the adherence of the population to sustainable
           diets. But, in addition, it is proposed to evaluate its effects on environmental
           indicators, metabolic biomarkers, and gut microbiota, as well as clinical aspects and
           body composition in a Mexican population sample. Because of the effectiveness of
           technologies use in nutritional and environmental interventions, the intervention
           program will be a digital one, for which a mobile application is being designed to
           evaluate and monitor the intervened population. Therefore, this will be a m-Health
           intervention program.

           One of the hypotheses of the work is that a sustainable-psycho-nutritional intervention
           digital program can modify the eating behavior of a Mexican population group and guide
           it towards a sustainable diet, generating decreases in glucose levels, total cholesterol
           (TC), LDL cholesterol (LDL-C), and triglycerides (TG), and increases in HDL cholesterol
           (HDL-C) levels. Likewise, another hypothesis is that this type of program can modify the
           composition of the gut microbiota of the population, promoting the proliferation of
           bacteria related to metabolic health; reduce the water and carbon footprint of the
           sample's diets; maintain adequate body fat levels in the population with an adequate
           body fat percentage or reduce them in the overweight or obese population; maintain blood
           pressure levels in the healthy population and lower them in the population with high
           blood pressure, and reduce the presence of acanthosis nigricans.

        2. Methods:

      It is proposed to carry out a quasi-experimental longitudinal study of three stages that will
      be related to each other.

      2.1 Stage 1: Design of the program: A sustainable-psycho-nutritional intervention program
      will be designed based on the characteristics of a sustainable diet for the national context
      of Mexico, adaptable to any regional context. It will include a mobile application that is
      being designed for this project, which will include a sustainable food guide,
      sustainable-psycho-nutritional workshops, sustainable recipes and food plans, and behavioral
      change techniques. The program will be designed based on the sustainable diets model and
      concept, the behavior change wheel model, the guideline for the development and evaluation of
      digital behavioral interventions in health care, and the guide to designing interventions of
      the behavior change wheel, which incorporate 3 stages and 8 development steps.

      2.1.1 Mobile application design: A mobile application (app) will be developed in
      collaboration with software and mobile applications developers and will be based on the
      user-centered methodology, and the guide for the design of digital interventions. It will
      contain the following behavioral modification techniques: education through workshops videos;
      persuasion by sending messages of risks and benefits, encouragement and coercion using a
      token economy, nudges by messaging, self-monitoring by graphical progress viewing, successive
      approaches by behavioral objectives addressing, and guides, through a sustainable food guide
      that will be designed by means of linear programming optimization using MATLAB®, and graphic
      design programs such as Canva®, Adobe Illustrator®, and BioRender®. For the token economy
      system, cut-off points will be established to be charged to the app. Additionally,
      educational workshops and meal plans will be designed, following the model of sustainable
      diets, and using the Nutriecology® Nutritional-Ecological software and the Nutrimind®
      Software for diet calculation. Likewise, the guidelines for the prescription of meal plans,
      menu design, and recipes for the Mexican population will be followed. Prior to the launch of
      the mobile application, its feasibility, acceptability, quality, and usability will be
      assessed. Also, it will be evaluated following the APEASE criteria, which include evaluating
      1) Affordability, 2) Practicability, 3) Effectiveness, and Cost-effectiveness, 4)
      Acceptability, 5) Side-effects/safety, and 6) Equity.

      2.1.2 Behavior change intervention design process:

      The process of design of the intervention will include:

      Stage 1: Understand the behavior:

      Step 1: Define the problem in behavioral terms:

      This step will be based on the available scientific evidence on the country's dietary and
      environmental situation, which reveals a high prevalence of overweight, obesity, and
      associated pathologies such as type 2 diabetes, dyslipidemia, and hypertension. Also, the
      highest values of dietary water and carbon footprints were found. These problems are mainly
      related to inadequate food consumption (which will be further detailed) and lack of physical
      activity.

      Step 2: Select target behavior:

      The target behaviors will be lack of physical activity performance, inadequate consumption of
      Mexican foods and dishes, fruits and vegetables, whole grains, legumes, seeds, and healthy
      fats, dairy products, eggs, fish and shellfish, chicken, red meat (beef and pork, and, in
      some cases, goat and lamb) and processed, ultra-processed foods and added and free sugars, as
      well as foods high in trans and saturated fats.

      Step 3: Specify the target behavior and Step 4: Identify what needs to change:

      Targets behaviors will be established as a goal-setting strategy, which has been reported to
      be one of the most effective methods for modifying dietary behaviors. Also, they will be
      addressed as successive approximations toward a sustainable diet, another effective behavior
      change technique. Targets behaviors will be:

        1. Increase physical activity.

        2. Increase the consumption of sustainable Mexican foods and dishes.

        3. Increase the consumption of fruits and vegetables.

        4. Increase the consumption of whole grains.

        5. Increase the consumption of legumes.

        6. Increase the intake of seeds and healthy fats.

        7. Reduce dairy consumption.

        8. Reduce the consumption of eggs.

        9. Reduce consumption of fish and shellfish.

       10. Reduce chicken consumption.

       11. Reduce the consumption of red (beef, pork, goat, and lamb) and processed meats.

       12. Reduce the consumption of ultra-processed foods.

       13. Reduce the intake of added and free sugars, as well as foods with a high content of
           trans and saturated fats.

      All foods whose consumption will be promoted will be aligned with the sustainability
      characteristics for the Mexican context, on the recommendations of a healthy diet provided by
      the WHO, and on the model QC7G for food and nutrition education, which will specify which
      foods to select, in which quantities, when to consumed them and how to prepare them. In
      addition to when to perform physical activity, specifying type and duration.

      Stage 2: Identify intervention options:

      Step 5: Intervention functions:

      The intervention functions from the behavior change wheel model will be: education,
      persuasion, incentivization, and coercion. These will be verified in relation to the APEASE
      criterion.

      Step 6: Policy categories:

      The policy category of the behavior change wheel model will be the guidelines. Therefore, a
      nutritional-sustainable food guide will be designed, using linear programming optimization,
      based on the FAO recommendations for the development of dietary guidelines, and covering the
      elements of the sustainable diets model as follows: 1) Wellness and Health: ABCD; A:
      anthropometric and body composition; B: biochemical data; C: clinical data. D: Dietetics. 2)
      Biodiversity, environment, and climate: carbon footprint and gray water footprint. 3) Equity
      and fair trade: food prices and socioeconomic level of the population. 4) "Eco-friendly",
      local, and seasonal foods: green and blue water footprint, locally produced and seasonal
      foods. 5) Cultural heritage and skills: Traditional Mexican diet, Mexican Diet Quality Index
      Adapted (IACDMx), and nutritional education based on a traditional diet. 6) Food needs,
      nutrients, food security, and access: personalized food plan according to individual
      requirements, preferences, and contexts.

      Subsequently, this nutritional-sustainable food guide will be accompanied by a system of
      equivalent foods that, in addition to incorporating the food's nutrients, will integrate
      their environmental impact. The calculation of the environmental impact will be made based on
      the calculation of the total, green, blue, and gray water footprint, using the Water
      Footprint Assessment method for Mexico. Likewise, the greenhouse gas emissions of foods will
      be calculated, using the Life Cycle Assessment method for food production and processing
      through pre-quantified databases. The prices and cultural characteristics of the main
      consumed foods in Mexico will be included. Prices will be obtained based on fieldwork in
      supermarkets, and a review of supermarket databases, while cultural aspects will be
      determined based on a literature review of the traditional Mexican diet.

      Once sustainability dimensions are calculated, a sustainable recipe book will be developed,
      including examples of food plans with individualization options. These food plans will be
      made up of a distribution of equivalent food rations and examples of menus that meet the
      nutritional and sustainability characteristics of the Mexican population, with adaptation
      options.

      Stage 3: Identify content and implementation options:

      Step 7: Behavior change techniques:

      Specific behavior change techniques will be used covering the selected intervention functions
      as follows:

        -  Education: successive approximations in the workshops addressing the target objectives.

        -  Persuasion: Nudges, risk, and benefits communication.

        -  Incentivization, coercion, and monitoring: messaging, remainders, and token economy
           through food registers by writing and photos on the mobile application.

        -  Social support: forum in the mobile app where participants can share pictures of their
           foods and their physical activity performance. Also, will be able to like the photos of
           other participants and comment on the photos. Also, a chat for the resolution of doubts
           between user and administrator will be included in the mobile application.

      Step 8: Mode of delivery:

      The mode of delivery will be digital since a mobile application is being designed and the
      workshops will be delivered on digital platforms in videos.

      2.2 Stage 2: Application of the sustainable-psycho-nutritional intervention program 2.2.1
      Participants Once the intervention program has been designed, it will be applied to a sample
      of Mexican young adults from the south of Jalisco, randomly divided into two groups: an
      experimental group (n=50) and a control group (n=50). This is based on recommendations for
      group designs in behavior modification programs. The sample size is according to the minimum
      suggested for nutritional interventions, and taking into account the possible desertion of
      the participants during the intervention, which can amount to more than 50% of the initial
      sample. It will be included a population between 18 and 35 years old, with Body Mass Index
      (BMI) values from 18.5 to 40, with or without risk factors for the development of chronic
      diseases, but without diagnosis with previous pharmacological treatment. The inclusion,
      exclusion, and elimination criteria will be detailed in further sections. Also, for being
      included in the study cut-off points to identify inadequate consumption and physical activity
      were established. The population will be invited to participate through social networks and
      posters at strategic points, such as Universities, gyms, and the downtown city. Young adults
      were selected as the population for this study since they are already considered adults who
      make autonomous food decisions, but at the same time, their young age makes them susceptible
      to behavioral modification. In addition, they represent parents or future parents, as well as
      the active population of Mexico, so providing nutritional-sustainable education to these
      people could generate long-term benefits for their health and that of their families.

      2.2.2 Procedure: Participants will be evaluated following the nutritional care process model.
      The first evaluation will be performed at the beginning of the intervention at baseline, and
      according to individual requirements, the behavioral objectives will be individually adapted
      and will be addressed for 7 weeks, considering 2 objectives per week, thus providing 2 weekly
      educational workshops. Also, personalized food plans will be prescribed, according to the
      linear programming optimization performed at MATLAB®.

      After 7 weeks of educational and nutritional intervention, at week 8, the experimental
      population will be divided into two sub-groups, where one group will stop being intervened
      completely (n = 25), and another will continue to receive messages through the mobile
      application (n = 25) for 8 weeks. Finally, at week 15, a final evaluation will be carried
      out. Participants will be evaluated in regard to Anthropometric, Biochemical, Clinical,
      Dietetics, Environmental, Socioeconomic level, and cultural aspects, Nutritional-sustainable
      knowledge, Behavioral aspects, and Physical activity (ABCD-ESNBP). These aspects will be
      evaluated according to the nutritional care process model, thus identifying the problem of
      the population, establishing the etiology, and stating the signs and symptoms.

      2.2.3 Sustainable-psycho-nutritional indicators: The ABCD-ESNBP indicators will be included
      in a complete clinical history that will be uploaded to the mobile application and will be
      evaluated according to the outcomes section.

      2.3 Stage 3: Effects of the sustainable-psycho-nutritional intervention program: As the last
      stage of this protocol, the corresponding laboratory analyses, and statistical tests will be
      carried out.

      2.3.1 Metabolic biomarkers analysis: For the analysis of metabolic biomarkers, colorimetric
      enzymatic methods will be used using the Spinreact® S. A/S A. U (Girona, Spain) laboratory
      kits, for fasting glucose determination (Cat. No. 1001190), TC (Cat. No. 41022), LDL-C (Cat.
      No. BSIS51-E), HDL-C (Cat. No. BSIS37-E) and TG (Cat. No. 1001313). The reference points for
      glucose values and lipid profiles will be taken from the regulations in force in Mexico.

      2.3.2 Gut microbiota analysis: For the analysis of the gut microbiota, the real-time
      quantitative polymerase chain reaction (qPCR) method will be followed. First, DNA will be
      extracted from the collected stool samples, following the protocol for rapid purification of
      genomic DNA from stool samples. The Qiagen brand commercial kit (1066790ES, USA) will be
      used. This procedure integrates two stages: lysis and separation of impurities from stool
      samples, for which Inhibitex Buffer will be used and DNA purification will be carried out by
      means of centrifugation columns. Once the bacterial DNA samples are obtained, they will be
      stored and labeled in sterile plastic microtubes (Eppendorf 1.6 mL) at a temperature of -80°C
      until further analysis.

      Next, the purity of the DNA will be verified, and its concentration will be determined using
      a NanoDrop Lite spectrophotometer (Thermo Scientific, Waltham, MA, USA). 1 µL of the DNA
      stock of each sample will be placed on the lens of the equipment and the sample will be read
      at a wavelength of 260 nm for DNA quantification and at 280 nm for protein quantification.
      The purity will be determined by calculating the index performed by the team, by dividing the
      reading at 260 nm by the reading at 280 nm and will be considered acceptable in a range of
      1.5 to 2. The concentration of the purified coproDNA sample will be measured by their
      absorbance ratio of 260/280 nm using the same spectrophotometer. This analysis corresponds to
      the absorbance index of nucleic acids and provides the final concentration in ng/µL.

      Once the previous analyzes have been completed, the identification of the gut microbiota will
      be carried out using the qPCR molecular technique, on the StepOne Applied BioSystems
      platform, using the SYBR Green reagent as DNA detection chemistry. This reagent is considered
      an agent that intercalates into the DNA double helix and fluoresces as the DNA copies are
      synthesized. Therefore, at a higher concentration of the DNA of interest (bacterial), the
      equipment will record a higher fluorescence signal. In this case, the analysis of interest
      will be carried out in the V3-V4 hypervariable region of the bacterial 16S rRNA gene. For
      this analysis, specific primers will be used. The bacterial load and relative abundance of
      the main bacteria present in the intestine (Firmicutes and Bacteroidetes) will be determined,
      as well as those related to particular types of diets, for example, Lactobacillus and
      Bifidobacterium that are related to healthy, vegetarian, and Mediterranean diets,
      Faecalibacterium prausnitzii that is related to healthy diets and an anti-inflammatory
      effect, as well as Akkermansia muciniphila, which besides of being related to
      anti-inflammatory effects is associated to the consumption of the Mexican pre-Hispanic diet.
      The presence of Prevotella copri will also be identified, which is one of the bacteria most
      related to plant-based diets and is considered anti-inflammatory and glucose modulator. The
      presence of Bilophila wadsworthia will also be identified, as it is related to diets with a
      high content of foods of animal origin, mainly dairy and meat, as well as in westernized
      diets. Likewise, the presence of Clostridium coccoides will be analyzed, as it is related to
      obesity and a high fat intake. Also, Streptococcus thermophilus will be included because it
      is related to dairy consumption. The exact procedure to follow regarding the qPCR run, as
      well as the specific conditions and temperatures of the analysis, are presented in a previous
      Mexican investigation.

      2.3.3 Evaluation of the adherence to the program: To measure the adherence of the intervened
      population to the program, an adapted questionnaire will be applied, which will consist of
      the contrast of the recommendations provided with the performance of the behaviors to
      promote. For example, questions about the type and intensity of physical activity performed
      and the amount and frequency of consumption of each of the foods included in the behavioral
      objectives will be included.

      2.3.4 Statistical analyses: The distribution of the data will be analyzed with the Kolmogorov
      Smirnov test. Descriptive analysis will be performed, including means, standard deviations,
      and medians. Next, the effects of the program on the selected variables will be assessed by
      comparing them between evaluations and between groups with t-student tests for paired and
      unpaired data, respectively, if a normal distribution is found. For no normally distributed
      data, the Wilcoxon test (repetitive measures) and the U de Mann Whitney test (independent
      groups) will be used. For no categorical variables, the chi-squared test will be used.
      Correlation analyses will also be performed, considering Pearson correlation for normally
      distributed data and Spearman correlations for no normally distributed data. Likewise,
      simple, and multiple linear regression models will be carried out, as well as binary logistic
      regression analysis reporting odds ratios, to identify relationships and risks between
      variables. Statistical analysis will be performed at the STATA V12® program.

      2.4 Ethical and biosafety considerations: This project has been already evaluated and
      approved by the Ethics Committee of the Center for Studies and Research in Behavior, of the
      University Center for Biological and Agricultural Sciences (CUCBA) from the University of
      Guadalajara with the number CUCBA/CEIC/CE/002/2022 and by the Technical Research Committee of
      the University Center of the South (CUSUR), with the number 2021D001. This protocol is also
      registered on Clinical Trials.gov (ID: NCT05457439). When performing the intervention, the
      Declaration of Helsinki and biosafety protocols of the Secretary of Health of Mexico will be
      followed all the time. All participants will sign an informed consent and their identities
      will be protected by the Federal Law on Protection of Personal Data Held by Private Parties.

      Both due to regulations in research with human beings, and due to the situation of the
      COVID-19 pandemic, a strict biosafety protocol will be followed, where mouth covers will be
      always worn, both by the evaluating staff and by the participants. Likewise, the sample
      collection personnel will wear protective glasses and sterile gloves and constant
      disinfection of the work area will be carried out. In addition, hazardous biological waste
      will be disposed of in a special trash can in accordance with the provisions of the Ministry
      of Health.

      3. Discussion: By developing this program, the first bases for the Mexican population (and
      future populations) to achieve a healthy and sustainable diet will be generated. Which can
      have positive effects on health outcomes and decrease the environmental impact of food
      consumption; thus addressing two of the main problems afflicting the world population. Also,
      a new concept is being proposed: The Sustainable-Psycho-Nutrition, which is an approach based
      on behavioral science that integrates the psychological, social, cultural, economic,
      nutritional, and environmental aspects of eating behavior, whose objective is to generate the
      necessary bases to carry out behavioral change interventions, to guide the eating behavior of
      the population, towards sustainable eating behaviors. Within this term, the
      nutritional-ecological education concept is also being launched, whose objective is to get
      people to acquire and performed the appropriate behavioral repertoire to determine what, how
      much, when, and how to eat, in relation to when, how much, and how energy is spent to
      maintain or recover their physical well-being, considering at all times the environmental
      impact of their behaviors and selecting the most sustainable foods, regarding the
      environment, culture, economy, preferences, food security, health, nutrition, among other
      factors.

      Besides those aspects, the mobile application that is currently being developed is going to
      be a tool that will facilitate the promotion of sustainable diets first at the national level
      in Mexico, and forward, worldwide. Also, the first sustainable food guide for Mexico's
      context will be generated. Which will consider not only sustainability aspects but
      psychological and behavioral aspects. Moreover, the workshops, recipes, and food plans that
      are going to be created will serve as tools for the health and environmental sector of the
      country to promote the consumption of sustainable diets. Finally, the link between gut
      microbiota and sustainable diets is a new aspect that this study will be characterized for
      the first time, specifically for the Mexican population. Finally, this project intends to
      bring attention to the importance of considering behavioral interventions and techniques for
      promoting sustainable diets.
    


Study Type

Interventional


Primary Outcome

Change from Baseline Gut Microbiota at week 8 and 15

Secondary Outcome

 Change from Signs of nutrient deficiencies or excess at week 8 and 15

Condition

Gut Microbiota

Intervention

Sustainable diet promotion through behavioral change intervention

Study Arms / Comparison Groups

 Experimental Group
Description:  Will be evaluated at baseline and will be intervened for 7 weeks, receiving educational workshops twice a week, addressing the target behaviors. They will also be prescribed a personalized food plan, will receive daily messages through the mobile application, and will have a doubt resolution chat. They will have a digital forum to post photos and comments about their food intake, and physical activity performance, and to like and comment on other participants' photos. They will be asked to enter food records and photos of their food intake into the mobile application, for which they will receive points for performing the expected behavior in a token economy. They will have access to their data for auto-monitoring. In week 8, the experimental group will be evaluated and divided into two sub-groups. One will be completely stopped intervening (n = 25) and one will continue receiving messages through the mobile app, but will no longer have workshops and food plan prescriptions (n = 25).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

100

Start Date

August 2022

Completion Date

December 2023

Primary Completion Date

January 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Being between 18 and 35 years old

          -  Being Mexican

          -  Reside in the South of Jalisco for at least 1 year

          -  Levels of physical activity below what is recommended and what is established as a
             criterion for inclusion in the study

          -  Consuming amounts of food below or above that established as criteria for inclusion in
             the study or in a lesser or greater frequency than recommended, according to the type
             of food

          -  Have a Smartphone

          -  Not having consumed antibiotics at least 3 months before the intervention

          -  Have a BMI between 18.5 and 40

          -  Not having a medical diagnosis of chronic disease under pharmacological treatment

          -  Not having a medical diagnosis of gastrointestinal disease

        Exclusion Criteria:

          -  Not signing the informed consent

          -  Not accepting to donate blood and/or stool samples

          -  Not being able to stand up to take anthropometric data

          -  Perform levels of physical activity above the minimum established as criteria for
             inclusion in the study

          -  Consume adequate levels of the foods to be promoted in the intervention program

          -  Being pregnant or lactating

          -  Suffer from a chronic disease such as type 2 diabetes mellitus, arterial hypertension,
             dyslipidemia, under medication

          -  Suffering from an autoimmune disease such as type 1 diabetes, hypo or hyperthyroidism

          -  Having a gastrointestinal disease such as Crohn's disease, ulcerative colitis, etc.

          -  Having used antibiotics less than 3 months ago

          -  Taking antidepressant medications or corticosteroids

          -  Consume probiotics or nutritional supplements, except protein powder
      

Gender

All

Ages

18 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Fatima E Housni, PhD, +523411017629, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT05457439

Organization ID

CIP/T/04/22


Responsible Party

Principal Investigator

Study Sponsor

University of Guadalajara

Collaborators

 Universidad de Granada

Study Sponsor

Fatima E Housni, PhD, Principal Investigator, University of Guadalajara


Verification Date

July 2022