Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Synergy 1
* Dietary Supplement: maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br>Maltodextrin, non digestible carbohydrate | Dietary Supplement: maltodextrin<br>* 8 grams/day during the first week and then 8 grams twice a day during 3 months<br>|
| Experimental: A<br>fructans, non digestible carbohydrates fermented in the caeco-colon | Dietary Supplement: Synergy 1<br>* 8 grams/day during the first week and then 8 grams twice a day during 3 months<br>* Other names: oligofructose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota composition | HITChip analysis (phylogenetic profiling by DNA microarray) | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fructans supplementation