Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance
Keywords
Abstract
Dates
Last Verified: | 06/30/2019 |
First Submitted: | 07/14/2019 |
Estimated Enrollment Submitted: | 07/14/2019 |
First Posted: | 07/16/2019 |
Last Update Submitted: | 04/12/2020 |
Last Update Posted: | 04/14/2020 |
Actual Study Start Date: | 01/06/2014 |
Estimated Primary Completion Date: | 12/29/2020 |
Estimated Study Completion Date: | 12/29/2020 |
Condition or disease
Intervention/treatment
Dietary Supplement: Placebo
Dietary Supplement: Experimental Alanine
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo 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 | Dietary Supplement: Placebo 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. |
Experimental: Experimental Alanine 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 | Dietary Supplement: Experimental Alanine Subjects will mix the alanine 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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) - Women of childbearing potential must agree to a urine pregnancy test before supplement is dispensed and to avoid pregnancy throughout the study. 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. - Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc. - Medication use: opioids, Tegaserod, laxatives, enemas - Difficulty Swallowing - Known food allergies or intolerance to any fiber supplements or other dietary nutritional supplements such as: Psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel). |
Outcome
Primary Outcome Measures
1. GI symptom score [4 weeks]
Secondary Outcome Measures
1. Fructose consumption [4 weeks]
2. Breath hydrogen and methane [4 weeks]
3. Quality of Life (SF-12) [4 weeks]