Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men
NCT ID: NCT01044680
Last Updated: 2010-01-08
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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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2006-10-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Nutriose
17 g NUTRIOSE consumed twice daily for 12 weeks
NUTRIOSE
17 grams of NUTRIOSE consumed twice daily for 12 weeks
Placebo
17 g maltodextrin consumed twice daily for 12 weeks
Placebo
17 g maltodextrin consumed twice daily for 12 weeks
Interventions
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NUTRIOSE
17 grams of NUTRIOSE consumed twice daily for 12 weeks
Placebo
17 g maltodextrin consumed twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* body mass index of 24-28 kg/m2
* current employment and residence at one of three manufacturing plants with a controlled setting and with similar regimented working conditions 7 days a week
Exclusion Criteria
* use of lipid-lowering/hypertension medication
* current insulin injection use
* contraindication to fiber supplements, e.g. Crohn's disease
* allergy to wheat products
* recent or current antibiotic use
20 Years
35 Years
MALE
Yes
Sponsors
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Sprim Advanced Life Sciences
OTHER
Roquette Freres
INDUSTRY
Responsible Party
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Roquette Freres
Principal Investigators
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Shuguang Li, MD
Role: PRINCIPAL_INVESTIGATOR
Tongji University Medical College
Locations
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Tongji University Medical College
Shanghai, , China
Countries
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References
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Pasman W, Wils D, Saniez MH, Kardinaal A. Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. Eur J Clin Nutr. 2006 Aug;60(8):1024-34. doi: 10.1038/sj.ejcn.1602418. Epub 2006 Feb 15.
van den Heuvel EG, Wils D, Pasman WJ, Saniez MH, Kardinaal AF. Dietary supplementation of different doses of NUTRIOSE FB, a fermentable dextrin, alters the activity of faecal enzymes in healthy men. Eur J Nutr. 2005 Oct;44(7):445-51. doi: 10.1007/s00394-005-0552-0. Epub 2005 Feb 9.
van den Heuvel EG, Wils D, Pasman WJ, Bakker M, Saniez MH, Kardinaal AF. Short-term digestive tolerance of different doses of NUTRIOSE FB, a food dextrin, in adult men. Eur J Clin Nutr. 2004 Jul;58(7):1046-55. doi: 10.1038/sj.ejcn.1601930.
Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.
Other Identifiers
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06-10- CN-Roquette-01
Identifier Type: -
Identifier Source: org_study_id
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