Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616057

Acronym

FRUCTOB

Enrollment

Registered

2008-02-15

Start date

2008-02-29

Completion date

2011-06-30

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

fructans supplementation

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.

Interventions

DIETARY_SUPPLEMENTSynergy 1

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

DIETARY_SUPPLEMENTmaltodextrin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
gut microbiota composition	3 months	HITChip analysis (phylogenetic profiling by DNA microarray)

Secondary

Measure	Time frame	Description
gut microbial-related metabolites (in urine and plasma)	3 months	NMR spectroscopic analysis of urine and plasma metabolic profiles
metabolic parameters (weight, BMI, glycemia, fat mass,...)	3 months	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026