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

Not Applicable

Terminated

• Conditions: Dietary Fructose Intolerance
• Interventions: Dietary Supplement: Metamucil; Dietary Supplement: supplemental L-alanine

• Registration Number: NCT01288495
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Metamucil	Subjects will consume the placebo prior to eating fructose-containing foods.
L-alanine	supplemental L-alanine	Subjects will consume l-alanine prior to eating fructose-containing foods.

Primary Outcome Measures

Name	Time	Method
GI symptom score	4 weeks	Change in GI symptom score with alanine \& placebo, when compared to the baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States