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