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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dietary Fructose Intolerance

Intervention / Treatment
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* Dietary Supplement: supplemental L-alanine
* Dietary Supplement: Metamucil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-99 years 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: Cognitive impairment or any other inability to provide informed consent Prisoners GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy Antibiotics in the previous 6 weeks History of bacterial overgrowth or lactose intolerance Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc. Known food allergies Medication use: opioids, Tegaserod, laxatives, enemas An allergy or intolerance to any fiber supplements or other dietary nutritional supplements such as: psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel). Difficulty swallowing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-alanine<br>Subjects will consume l-alanine prior to eating fructose-containing foods. | Dietary Supplement: supplemental L-alanine<br>* Subjects will consume l-alanine prior to eating fructose-containing foods.<br>|
| Placebo Comparator: Placebo<br>Subjects will consume the placebo prior to eating fructose-containing foods. | Dietary Supplement: Metamucil<br>* Subjects will consume the placebo prior to eating fructose-containing foods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI symptom score | Change in GI symptom score with alanine & placebo, when compared to the baseline | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructose consumption | Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline using prospective food diaries | 4 weeks | 
| Breath hydrogen and methane | Changes in Breath hydrogen and/or methane values with Alanine and Placebo when compared with baseline | 4 weeks | 
| Quality of life (SF-12) | Changes in SF-12 scores between baseline and after alanine and placebo | 4 weeks |