ObesityFRUCTOBNCT00616057
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
A study testing Synergy 1 and maltodextrin in people with Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Synergy 1 and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI>30 kg/m2
Who cannot join
- 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
Show all 10Show fewer
- pregnant women
- anti-diabetics drugs ou slimming drugs
- previous bariatric surgery
- severe oesophagus reflux
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint Luc
Brussels, Branbant Wallon, 1200
About this study
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.
- Conditions
- Obesity
- Being tested
- Synergy 1, maltodextrin
- Keywords
- fructans supplementation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synergy 1Dietary supplement
Also called inulin, oligofructose
8 grams/day during the first week and then 8 grams twice a day during 3 months
maltodextrinDietary supplement
8 grams/day during the first week and then 8 grams twice a day during 3 months
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Maltodextrin, non digestible carbohydrate Receives: Dietary Supplement: maltodextrin |
| A | Experimental | fructans, non digestible carbohydrates fermented in the caeco-colon Receives: Dietary Supplement: Synergy 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota composition
HITChip analysis (phylogenetic profiling by DNA microarray)
Measured: 3 months
Secondary outcomes (2)
gut microbial-related metabolites (in urine and plasma)
NMR spectroscopic analysis of urine and plasma metabolic profiles
Measured: 3 months
metabolic parameters (weight, BMI, glycemia, fat mass,...)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thissen Jean-Paul, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616057
- Sponsor's protocol ID
- 2007/21/NOV/300
- Other IDs
- B40320072930
- Acronym
- FRUCTOB
- Status last verified
- Jul 2012
- First submitted
- 4 Feb 2008
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24969566
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00616057
- Acronym / sponsor ID
- FRUCTOB / 2007/21/NOV/300
- Conditions
- Obesity
- Keywords
- fructans supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Dietary Supplement: maltodextrinMaltodextrin, non digestible carbohydrate |
| A | Experimental | Dietary Supplement: Synergy 1fructans, non digestible carbohydrates fermented in the caeco-colon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI>30 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synergy 1Also: inulin, oligofructose8 grams/day during the first week and then 8 grams twice a day during 3 months | Dietary supplement | A |
| maltodextrin8 grams/day during the first week and then 8 grams twice a day during 3 months | Dietary supplement | B |
Primary outcome
gut microbiota composition
Time frame: 3 months
HITChip analysis (phylogenetic profiling by DNA microarray)
2 secondary outcomes
gut microbial-related metabolites (in urine and plasma)
Time frame: 3 months
metabolic parameters (weight, BMI, glycemia, fat mass,...)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Derived from this study: PubMed 24969566Salazar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thissen Jean-Paul principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synergy 1 and maltodextrin in people with Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota composition (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00616057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012.