Clinical Trial: Long Term Fructose

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional




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.


Detailed Summary:
Sponsor: Augusta University




Current Primary Outcome: GI symptom score [ Time Frame: 8 weeks ]

Change in GI symptom score with alanine & placebo, when compared to the baseline


Original Primary Outcome: Same as current

Current Secondary Outcome: Fructose consumption [ Time Frame: 8 weeks ]

Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline


Original Secondary Outcome: Same as current

Information By: Augusta University




Dates:
Date Received: January 31, 2011
Date Started: February 2009
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014