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Experimental Alanine for Fructose Intolerance
N/A
Waitlist Available
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial suggests that alanine may have a role in the management of dietary fructose intolerance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GI symptom score
Secondary outcome measures
Breath hydrogen and methane
Fructose consumption
Quality of Life (SF-12)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental AlanineExperimental Treatment1 Intervention
L-alanine, USP (Spectrum® Chemicals and Laboratory Products, Gardena, CA) will be packaged and dispensed by one member of the research staff who will have no other role in the study. A one-month supply will be dispensed to the subjects.
Meal L-Alanine Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops
Group II: PlaceboPlacebo Group1 Intervention
Psyllium powder is used as the placebo. A member of the research staff will package and dispense L-alanine and placebo in similar containers. A standard measuring spoon will be provided to the subject for preparing the placebo solution. Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
Meal Placebo Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alanine
2013
N/A
~130
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
210 Previous Clinical Trials
84,963 Total Patients Enrolled
3 Trials studying Fructose Intolerance
1,195 Patients Enrolled for Fructose Intolerance
Frequently Asked Questions
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