Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men

Overweight Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044680
• Other study ID #: 06-10- CN-Roquette-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 6, 2010
• Last updated: January 7, 2010
• Start date: October 2006
• Est. completion date: February 2007

Study information

• Verified date: January 2010
• Source: Roquette Freres
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Overweight
• Syndrome

Intervention

Dietary Supplement:
• NUTRIOSE
17 grams of NUTRIOSE consumed twice daily for 12 weeks
• Placebo
17 g maltodextrin consumed twice daily for 12 weeks

Locations

Country	Name	City	State
China	Tongji University Medical College	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Roquette Freres	Sprim Advanced Life Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Epub 2006 Feb 15. — View 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. — View 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. Epub 2005 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determinants of metabolic syndrome		12 weeks	No