The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
| Status: | Terminated |
|---|---|
| Conditions: | Obesity Weight Loss, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | December 2015 |
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
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
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.
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.
Inclusion Criteria:
- BMI between 20 and 30 kg/m2 inclusive
- Weight ≥ 65 kg for females, and ≥ 55 kg for males
Exclusion Criteria:
- Pregnant or nursing.
- Diabetes Mellitus
- Any medication to reduce lipids
- History of gastrointestinal surgery, except for cholecystectomy or appendectomy
- History of malabsorption
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