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

April 25, 2016 updated by: Frank Greenway, Pennington Biomedical Research Center
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Fat Excretion compared at three time periods.
Time Frame: 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
Assessment of change at each fourth, fifth, and sixth day of each feeding period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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.
The duration of the 18 days in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Quest Nutrition LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2013-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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