Clinical trial NCT01044680: Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men
Official title: The Effects of NUTRIOSE®FB Dietary Fiber Supplementation on the Satiety, Body Fat Distribution, and Metabolic Syndrome Biomarkers of Overweight Adult Chinese Men 20-35 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overweight
Metabolic Syndrome X
Keywords: fiber
metabolic syndrome
overweight
satiety
Lead sponsor: Roquette Freres
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2010-01-08
Enrollment: 120
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body composition, satiety, and determinants of metabolic syndrome in overweight men.

Detailed description: Previous trials of fiber supplementation have yielded equivocal results on body composition, satiety, and determinants of metabolic syndrome. This double-blind, randomized, placebo-controlled study was conducted to determine the effects of a proprietary soluble dextrin dietary fiber supplement (NUTRIOSE®) on these parameters in overweight males.

Eligibility criteria: Inclusion Criteria:

* males 20-35 years
* 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:

* current or recent dietary fiber supplementation
* 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

Primary outcomes:
measure: Determinants of metabolic syndrome
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji University Medical College
Study officials:
affiliation: Tongji University Medical College
name: Shuguang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.