Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Obesity Clinical Trial

— FRUCTOB  

Official title:

Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616057
• Other study ID #: 2007/21/NOV/300
• Secondary ID: B40320072930
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: July 4, 2012
• Start date: February 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Commission d'Ethique Biomédicale Hospitalo-facultaire
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Synergy 1
8 grams/day during the first week and then 8 grams twice a day during 3 months
• maltodextrin
8 grams/day during the first week and then 8 grams twice a day during 3 months

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint Luc	Bruxelles	Branbant Wallon

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota composition	HITChip analysis (phylogenetic profiling by DNA microarray)	3 months	No
Secondary	gut microbial-related metabolites (in urine and plasma)	NMR spectroscopic analysis of urine and plasma metabolic profiles	3 months	No
Secondary	metabolic parameters (weight, BMI, glycemia, fat mass,...)		3 months	No