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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01910558
• Collaborator: Quest Nutrition LLC (Other)
• Enrollment: 0
• Location: 1
• Arms: 3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Cardiovascular Disease	Dietary Supplement: Alpha-cyclodextrin and digestible starch; Dietary Supplement: Alpha-cyclodextrin; Dietary Supplement: Digestible starch	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alpha-cyclodextrin and digestible starch Supplementation with three grams alpha cyclodextrin with three grams of digestible starch	Dietary Supplement: Alpha-cyclodextrin; Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
Experimental: Alpha-cyclodextrin Supplementation with six grams of alpha-cyclodextrin	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
Placebo Comparator: Digestible Starch Supplementation with six grams of digestible starch	Dietary Supplement: Digestible starch; Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Quest Nutrition LLC

Investigators

• Principal Investigator: Frank L Greenway, M.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of α-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.
• 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.

• Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT01910558
• Other Study ID Numbers: PBRC 2013-043
• First Posted: Jul 29, 2013
• Last Update Posted: Apr 27, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Frank Greenway, Principal Investigator, Pennington Biomedical Research Center: Alpha-cyclodextrin; Dietary fiber; Fecal fat; Saturated fat
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 27, 2016