The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
- Conditions
- ObesityCardiovascular Disease
- Interventions
- Dietary Supplement: Alpha-cyclodextrin and digestible starchDietary Supplement: Alpha-cyclodextrinDietary Supplement: Digestible starch
- Registration Number
- NCT01910558
- Lead Sponsor
- Pennington Biomedical Research Center
- Brief Summary
Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control
- Detailed Description
Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- BMI between 20 and 30 kg/m2 inclusive
- Weight ≥ 65 kg for females, and ≥ 55 kg for males
- Pregnant or nursing.
- Diabetes Mellitus
- Any medication to reduce lipids
- History of gastrointestinal surgery, except for cholecystectomy or appendectomy
- History of malabsorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Alpha-cyclodextrin Alpha-cyclodextrin and digestible starch Supplementation with six grams of alpha-cyclodextrin Alpha-cyclodextrin and digestible starch Alpha-cyclodextrin Supplementation with three grams alpha cyclodextrin with three grams of digestible starch Digestible Starch Digestible starch Supplementation with six grams of digestible starch
- Primary Outcome Measures
Name Time Method Fecal Fat Excretion compared at three time periods. Assessment of change at each fourth, fifth, and sixth day of each feeding period. Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18
- Secondary Outcome Measures
Name Time Method Adverse events The duration of the 18 days in the study. Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated.
Trial Locations
- Locations (1)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States