Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance
Primary Purpose
Dietary Fructose Intolerance
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
supplemental L-alanine
Metamucil
Sponsored by
About this trial
This is an interventional treatment trial for Dietary Fructose Intolerance
Eligibility Criteria
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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L-alanine
Placebo
Arm Description
Subjects will consume l-alanine prior to eating fructose-containing foods.
Subjects will consume the placebo prior to eating fructose-containing foods.
Outcomes
Primary Outcome Measures
GI symptom score
Change in GI symptom score with alanine & placebo, when compared to the baseline
Secondary Outcome Measures
Fructose consumption
Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline using prospective food diaries
Breath hydrogen and methane
Changes in Breath hydrogen and/or methane values with Alanine and Placebo when compared with baseline
Quality of life (SF-12)
Changes in SF-12 scores between baseline and after alanine and placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01288495
Brief Title
Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance
Official Title
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
PI moved institutions and changed study protocol
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Fructose Intolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-alanine
Arm Type
Experimental
Arm Description
Subjects will consume l-alanine prior to eating fructose-containing foods.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will consume the placebo prior to eating fructose-containing foods.
Intervention Type
Dietary Supplement
Intervention Name(s)
supplemental L-alanine
Intervention Description
Subjects will consume l-alanine prior to eating fructose-containing foods.
Intervention Type
Dietary Supplement
Intervention Name(s)
Metamucil
Intervention Description
Subjects will consume the placebo prior to eating fructose-containing foods.
Primary Outcome Measure Information:
Title
GI symptom score
Description
Change in GI symptom score with alanine & placebo, when compared to the baseline
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fructose consumption
Description
Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline using prospective food diaries
Time Frame
4 weeks
Title
Breath hydrogen and methane
Description
Changes in Breath hydrogen and/or methane values with Alanine and Placebo when compared with baseline
Time Frame
4 weeks
Title
Quality of life (SF-12)
Description
Changes in SF-12 scores between baseline and after alanine and placebo
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
12. IPD Sharing Statement
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Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance
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