Clinical trial NCT01910558: The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
Official title: The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Keywords: Alpha-cyclodextrin
Dietary fiber
Fecal fat
Saturated fat
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Quest Nutrition LLC
First posted: 2013-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Fecal Fat Excretion compared at three time periods.
timeFrame: Assessment of change at each fourth, fifth, and sixth day of each feeding period.
Secondary outcomes:
measure: Adverse events
timeFrame: The duration of the 18 days in the study.
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.
citation: Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687.
citation: Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012.