Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome (FRUCTOB)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Synergy 1
maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring fructans supplementation
Eligibility Criteria
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
Sites / Locations
- Cliniques universitaires Saint Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
B
A
Arm Description
Maltodextrin, non digestible carbohydrate
fructans, non digestible carbohydrates fermented in the caeco-colon
Outcomes
Primary Outcome Measures
gut microbiota composition
HITChip analysis (phylogenetic profiling by DNA microarray)
Secondary Outcome Measures
gut microbial-related metabolites (in urine and plasma)
NMR spectroscopic analysis of urine and plasma metabolic profiles
metabolic parameters (weight, BMI, glycemia, fat mass,...)
Full Information
NCT ID
NCT00616057
First Posted
February 4, 2008
Last Updated
July 4, 2012
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT00616057
Brief Title
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
Acronym
FRUCTOB
Official Title
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
fructans supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Maltodextrin, non digestible carbohydrate
Arm Title
A
Arm Type
Experimental
Arm Description
fructans, non digestible carbohydrates fermented in the caeco-colon
Intervention Type
Dietary Supplement
Intervention Name(s)
Synergy 1
Other Intervention Name(s)
inulin, oligofructose
Intervention Description
8 grams/day during the first week and then 8 grams twice a day during 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
8 grams/day during the first week and then 8 grams twice a day during 3 months
Primary Outcome Measure Information:
Title
gut microbiota composition
Description
HITChip analysis (phylogenetic profiling by DNA microarray)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
gut microbial-related metabolites (in urine and plasma)
Description
NMR spectroscopic analysis of urine and plasma metabolic profiles
Time Frame
3 months
Title
metabolic parameters (weight, BMI, glycemia, fat mass,...)
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thissen Jean-Paul
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint Luc
City
Bruxelles
State/Province
Branbant Wallon
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
24969566
Citation
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.
Results Reference
derived
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Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
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