Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: maltodextrin; Dietary Supplement: Synergy 1

• Registration Number: NCT00616057
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... Some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation.

In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al, Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in healthy human. An intervention study in obese patients is thus needed to study the effects of fructans in the target population.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2010-05
• Study Completion: 2011-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• BMI>30 kg/m2

Exclusion Criteria

• acute or chronic evoluting disease
• alcohol consumption > 30 units/week
• more than 30 minutes of sports 3 times/week
• usual consumption of pre/probiotics or fibers supplement
• recent consumption of antibiotics
• slimming diet or unusual diet
• pregnant women
• anti-diabetics drugs ou slimming drugs
• previous bariatric surgery
• severe oesophagus reflux

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	maltodextrin	Maltodextrin, non digestible carbohydrate
A	Synergy 1	fructans, non digestible carbohydrates fermented in the caeco-colon

Primary Outcome Measures

Name	Time	Method
gut microbiota composition	3 months	HITChip analysis (phylogenetic profiling by DNA microarray)

Secondary Outcome Measures

Name	Time	Method
gut microbial-related metabolites (in urine and plasma)	3 months	NMR spectroscopic analysis of urine and plasma metabolic profiles
metabolic parameters (weight, BMI, glycemia, fat mass,...)	3 months

Trial Locations

Locations (1)

Cliniques universitaires Saint Luc; 🇧🇪 Bruxelles, Branbant Wallon, Belgium