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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00616057
First received: February 4, 2008
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Synergy 1
Dietary Supplement: maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • gut microbiota composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HITChip analysis (phylogenetic profiling by DNA microarray)


Secondary Outcome Measures:
  • gut microbial-related metabolites (in urine and plasma) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    NMR spectroscopic analysis of urine and plasma metabolic profiles

  • metabolic parameters (weight, BMI, glycemia, fat mass,...) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Maltodextrin, non digestible carbohydrate
Dietary Supplement: maltodextrin
8 grams/day during the first week and then 8 grams twice a day during 3 months
Experimental: A
fructans, non digestible carbohydrates fermented in the caeco-colon
Dietary Supplement: Synergy 1
8 grams/day during the first week and then 8 grams twice a day during 3 months
Other Names:
  • inulin
  • oligofructose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00616057

Locations
Belgium
Cliniques universitaires Saint Luc
Bruxelles, Branbant Wallon, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Thissen Jean-Paul Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00616057     History of Changes
Other Study ID Numbers: 2007/21/NOV/300, B40320072930
Study First Received: February 4, 2008
Last Updated: July 4, 2012
Health Authority: Belgium: Commission d'Ethique Biomédicale Hospitalo-facultaire

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
fructans supplementation

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014