The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion (FAT ABSORBER)

Pennington Biomedical Research Center

Status: Withdrawn

Conditions: Obesity; Cardiovascular Disease

Treatments: Dietary Supplement: Alpha-cyclodextrin and digestible starch; Dietary Supplement: Digestible starch; Dietary Supplement: Alpha-cyclodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT01910558

PBRC 2013-043

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Alpha-cyclodextrin and digestible starch

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Alpha-cyclodextrin

Alpha-cyclodextrin

Experimental group

Description:

Supplementation with six grams of alpha-cyclodextrin

Treatment:

Dietary Supplement: Alpha-cyclodextrin and digestible starch

Digestible Starch

Placebo Comparator group

Description:

Supplementation with six grams of digestible starch

Treatment:

Dietary Supplement: Digestible starch