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

Phase 2
Completed
Conditions
Overweight
Metabolic Syndrome X
Interventions
Dietary Supplement: NUTRIOSE
Dietary Supplement: Placebo
Registration Number
NCT01044680
Lead Sponsor
Roquette Freres
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
120
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NutrioseNUTRIOSE17 g NUTRIOSE consumed twice daily for 12 weeks
PlaceboPlacebo17 g maltodextrin consumed twice daily for 12 weeks
Primary Outcome Measures
NameTimeMethod
Determinants of metabolic syndrome12 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tongji University Medical College

🇨🇳

Shanghai, China

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