The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
NCT ID: NCT01910558
Last Updated: 2016-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Alpha-cyclodextrin and digestible starch
Supplementation with three grams alpha cyclodextrin with three grams of digestible starch
Alpha-cyclodextrin
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
Alpha-cyclodextrin
Supplementation with six grams of alpha-cyclodextrin
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
Digestible Starch
Supplementation with six grams of digestible starch
Digestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch
Interventions
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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
Alpha-cyclodextrin
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
Digestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch
Eligibility Criteria
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Inclusion Criteria
* Weight ≥ 65 kg for females, and ≥ 55 kg for males
Exclusion Criteria
* Diabetes Mellitus
* Any medication to reduce lipids
* History of gastrointestinal surgery, except for cholecystectomy or appendectomy
* History of malabsorption
18 Years
60 Years
ALL
Yes
Sponsors
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Quest Nutrition LLC
UNKNOWN
Pennington Biomedical Research Center
OTHER
Responsible Party
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Frank Greenway
Principal Investigator
Principal Investigators
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Frank L Greenway, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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PBRC 2013-043
Identifier Type: -
Identifier Source: org_study_id
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