NCT00616057

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

February 4, 2008

Last Update Submit

July 4, 2012

Conditions

Obesity

Keywords

fructans supplementation

Outcome Measures

Primary Outcomes (1)

  • gut microbiota composition

    HITChip analysis (phylogenetic profiling by DNA microarray)

    3 months

Secondary Outcomes (2)

  • gut microbial-related metabolites (in urine and plasma)

    3 months

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

    3 months

Study Arms (2)

B

PLACEBO COMPARATOR

Maltodextrin, non digestible carbohydrate

Dietary Supplement: maltodextrin

A

EXPERIMENTAL

fructans, non digestible carbohydrates fermented in the caeco-colon

Dietary Supplement: Synergy 1

Interventions

Synergy 1DIETARY_SUPPLEMENT

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

Also known as: inulin, oligofructose
A
maltodextrinDIETARY_SUPPLEMENT

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, Branbant Wallon, 1200, Belgium

Location

Related Publications (1)

  • Salazar N, Dewulf EM, Neyrinck AM, Bindels LB, Cani PD, Mahillon J, de Vos WM, Thissen JP, Gueimonde M, de Los Reyes-Gavilan CG, Delzenne NM. Inulin-type fructans modulate intestinal Bifidobacterium species populations and decrease fecal short-chain fatty acids in obese women. Clin Nutr. 2015 Jun;34(3):501-7. doi: 10.1016/j.clnu.2014.06.001. Epub 2014 Jun 11.

    PMID: 24969566DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Inulinoligofructosemaltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Thissen Jean-Paul

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2011

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

BE(1)