Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

NCT ID: NCT00616057

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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fructans supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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B

Maltodextrin, non digestible carbohydrate

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

A

fructans, non digestible carbohydrates fermented in the caeco-colon

Group Type EXPERIMENTAL

Synergy 1

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Synergy 1

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

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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inulin oligofructose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thissen Jean-Paul

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint Luc

Brussels, Branbant Wallon, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24969566 (View on PubMed)

Other Identifiers

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B40320072930

Identifier Type: -

Identifier Source: secondary_id

2007/21/NOV/300

Identifier Type: -

Identifier Source: org_study_id