Evaluation of Fructanes Supplementation on Parameters of Metabolic Syndrome - Full Text View

Sponsored by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00616057

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 and diabetics patients is thus needed to study the effects of fructans in the target population.

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

MedlinePlus related topics: Diabetes Dietary Supplements Obesity

Drug Information available for: Inulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Fructanes Supplementation on Parameters of Metabolic Syndrome

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

gut microflora in faeces [ Time Frame: 3 months ] [ Designated as safety issue: No ]
gut peptides in serum [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Placebo Comparator Maltodextrin, non digestible carbohydrate	Dietary Supplement: maltodextrin 8 grams/day during the first week and then 8 grams twice a day during 3 months
A: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI>25 kg/m2
fasted glycemia > 126 mg/dl and/or fed glycemia (2 hours post-prandial)> 200 mg/dl
Hb1ac < 6.5%

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

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

Locations

Belgium, Branbant Wallon
Cliniques universitaires Saint Luc	Recruiting
Bruxelles, Branbant Wallon, Belgium, 1200
Contact: Thissen Jean-Paul, Pr. +3227645469 jeanpaul.thissen@uclouvain.be

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

Responsible Party:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain ( Professor Jean-Paul Thissen )
Study ID Numbers:	2007/21/NOV/300, B40320072930
Study First Received:	February 4, 2008
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00616057
Health Authority:	Belgium: Commission d'Ethique Biomédicale Hospitalo-facultaire

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

fructans supplementation

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Diabetes Mellitus

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009