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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Dietary Fructose Intolerance

In brief

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.

Key facts

Study ID

NCT01288495

Run by

Augusta University

People needed

15

Starts

2009-02-01

Expected to finish

2011-12-01

Last updated by the study team

2020-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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