Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance

Brief Title

Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance

Official Title

Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Crossover Study

Brief Summary

      Data suggest that alanine may facilitate the intestinal absorption of fructose in patients
      with DFI and thereby may decrease GI symptoms.

      We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks
      that contain foods with free fructose or high fructose content will decrease GI symptoms in
      subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose.

      Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or
      placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a
      randomized, double blind, cross over study.

      Methods: We propose to investigate the effects of co-administration of equi-molar doses of
      L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose
      intolerance, in a randomized, double blind, cross over study.

      Data Analysis: The primary outcome measure will be a comparison of baseline breath sample
      values and study visit breath sample values. Additionally, we will assess subject-reported
      occurence and severity of nine gastrointestinal symptoms during the test on a visual analog
      scale (VAS).

      Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve
      with ingestion of supplemental L-alanine (along with foods containing free fructose or high
      fructose content). We additionally expect treatment of DFI with administration of L-alanine
      powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for
      patients.
    



Study Type

Interventional


Primary Outcome

GI symptom score

Secondary Outcome

 Fructose consumption

Condition

Dietary Fructose Intolerance

Intervention

supplemental L-alanine

Study Arms / Comparison Groups

 L-alanine
Description:  Subjects will consume l-alanine prior to eating fructose-containing foods.

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

Dietary Supplement

Estimated Enrollment

15

Start Date

February 2009

Completion Date

December 2011

Primary Completion Date

December 2011

Eligibility Criteria

        Inclusion Criteria:

          1. Age between 18-99 years

          2. Diagnosis of fructose malabsorption (positive breath test after ingestion of 25 grams
             of fructose defined as either (a) ≥ 20 ppm rise of breath H2/CH4/both over baseline
             values or a successive rise of ≥ 5 ppm over baseline and in 3 consecutive breath
             samples)

        Exclusion Criteria:

          1. Cognitive impairment or any other inability to provide informed consent

          2. Prisoners

          3. GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy

          4. Antibiotics in the previous 6 weeks

          5. History of bacterial overgrowth or lactose intolerance

          6. Major co-morbid illnesses, including chronic pancreatitis, celiac disease,
             inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc.

          7. Known food allergies

          8. Medication use: opioids, Tegaserod, laxatives, enemas

          9. An allergy or intolerance to any fiber supplements or other dietary nutritional
             supplements such as: psyllium (Metamucil), Maltodextrin, Citric Acid, and
             methylcellulose (Citrucel).

         10. Difficulty swallowing
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01288495

Organization ID

Long Term Fructose


Responsible Party

Principal Investigator

Study Sponsor

Augusta University


Study Sponsor

, , 


Verification Date

April 2020