Trial | NCT01910558  Report issue

Official Title

The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    starch ...

  • Study Participants

    0
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
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.
Study Started
Oct 31
2013
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Apr 27
2016
Estimate

Dietary Supplement Digestible starch

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch

Dietary Supplement Alpha-cyclodextrin and digestible starch

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch

Dietary Supplement Alpha-cyclodextrin

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin

Alpha-cyclodextrin and digestible starch Active Comparator

Supplementation with three grams alpha cyclodextrin with three grams of digestible starch

Alpha-cyclodextrin Experimental

Supplementation with six grams of alpha-cyclodextrin

Digestible Starch Placebo Comparator

Supplementation with six grams of digestible starch

Criteria 

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
No Results Posted