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

Roquette

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight; Metabolic Syndrome X

Treatments: Dietary Supplement: NUTRIOSE; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01044680

06-10- CN-Roquette-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups, including a placebo group

Nutriose

Experimental group

Description:

17 g NUTRIOSE consumed twice daily for 12 weeks

Treatment:

Dietary Supplement: NUTRIOSE

Placebo

Placebo Comparator group

Description:

17 g maltodextrin consumed twice daily for 12 weeks

Treatment:

Dietary Supplement: Placebo