Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome (FRUCTOB)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: maltodextrin; Dietary Supplement: Synergy 1

Study type: Interventional

Funder types: Other

Identifiers

NCT00616057

B40320072930

2007/21/NOV/300

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

B

Placebo Comparator group

Description:

Maltodextrin, non digestible carbohydrate

Treatment:

Dietary Supplement: maltodextrin

A

Experimental group

Description:

fructans, non digestible carbohydrates fermented in the caeco-colon

Treatment:

Dietary Supplement: Synergy 1