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The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

NCT01910558 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-04-27

No results posted yet for this study

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

Conditions

Interventions

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

DIETARY_SUPPLEMENT

Digestible starch

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

Sponsors & Collaborators

  • Quest Nutrition LLC

    collaborator UNKNOWN

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Frank L Greenway, M.D. · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910558 on ClinicalTrials.gov