Investigation of Alanine in Fructose Intolerance: A Dose Ranging Study
Recruitment status was: Recruiting
Over the past few decades, fructose is increasingly being used as a sweetener/ additive in a variety of foods. Incomplete absorption of fructose has been implicated as a cause of gastrointestinal symptoms. In tertiary care centers, the prevalence of fructose malabsorption in subjects with unexplained GI symptoms is thought to be between 11-50%, when assessed with breath tests following administration of 25 grams of fructose in a 10% solution. Restriction of dietary fructose has been shown to improve symptoms in these patients to an extent. Currently, there are no therapeutic agents that improve intestinal fructose absorption and thereby decrease symptoms. Studies in the pediatric population have shown that fructose absorption in the small intestine is increased in the presence of glucose or amino acids, especially alanine.
The investigators' objective is to assess whether co-administration of an oral solution of L-alanine facilitates fructose absorption and decreases gastrointestinal (GI) symptoms associated with fructose malabsorption in subjects undergoing standard fructose breath test when compared to placebo.
Methods and analysis:
The investigators propose a randomized, double-blind study in 40 subjects with known fructose intolerance. After an overnight fast, each subject will receive an oral solution of 12.5 grams of alanine in 125cc of water or placebo. Next, the subject will receive an oral solution of 25 grams of fructose in a 10% solution. Serum, urine and breath samples will be collected at baseline and at 30-minute intervals for 4 hours. GI symptoms will also be assessed and recorded at 30 minute intervals using a standard questionnaire. Repeated measures ANOVA will be used to compare the data obtained during the study protocol with the baseline (pre-study) data.
Co-administration of alanine with fructose may improve fructose absorption and decrease symptoms in subjects with fructose intolerance.
Hypothesis: Ingestion of alanine along with fructose, will facilitate intestinal absorption of fructose in subjects with fructose malabsorption.
Aim: To investigate the effects of co-administration of equi-molar doses of alanine on a) the absorption of fructose and b) the occurrence of GI symptoms in subjects with fructose malabsorption.
|Fructose Intolerance||Dietary Supplement: Placebo Dietary Supplement: Alanine||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Investigation of Alanine in Fructose Intolerance: A Randomized, Double Blind, Dose Ranging, Placebo Controlled Study|
- Decrease breath Hydrogen and/or Methane production [ Time Frame: less than 6 months ]
- Occurrence or severity of GI symptoms during the test [ Time Frame: less than 6 months ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Subjects will receive placebo (mix of sugar and salt).
Dietary Supplement: Placebo
Subjects will receive placebo (mix of sugar and salt) 20 minutes before consuming fructose.
Experimental: Alanine - 12.5
Subjects will receive 12.5 grams of alanine
Dietary Supplement: Alanine
Subjects will receive 12.5 grams of alanine 20 minutes before consuming fructose.
Experimental: Alanine - 25
Subjects will receive 25 grams of alanine.
Dietary Supplement: Alanine
Subjects will receive 25 grams of alanine 20 minutes before consuming fructose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185210
|Contact: Satish SC Rao, MDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Satish SC Rao, MD 319-353-6602 firstname.lastname@example.org|
|Principal Investigator:||Satish Rao, Md, PhD||University of Iowa|