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OpenTrials
Completed

NCT Number: NCT00616057

Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint Luc

Brussels, Branbant Wallon, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synergy 1

Dietary Supplement

8 grams/day during the first week and then 8 grams twice a day during 3 months

Other names: inulin, oligofructose

Maltodextrin

Dietary Supplement

8 grams/day during the first week and then 8 grams twice a day during 3 months

Primary outcomes

  1. gut microbiota composition

    Time frame: 3 months

    HITChip analysis (phylogenetic profiling by DNA microarray)

Secondary outcomes

  1. gut microbial-related metabolites (in urine and plasma)

    Time frame: 3 months

    NMR spectroscopic analysis of urine and plasma metabolic profiles

  2. metabolic parameters (weight, BMI, glycemia, fat mass,...)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: FRUCTOB

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 15, 2008
Registry last updated
Jul 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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