AzTrials
AzTrials

OverweightPhase 1ROQ_NUTRIMETABNCT01897662

Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects

A Phase 1 study testing NUTRIOSE FB06 and GLUCIIDEX 21 in people with Overweight, run by Nealth Sarl at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight
What is being tested?
NUTRIOSE FB06 and GLUCIIDEX 21
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteFrance
Study dates
Apr 2012to Jun 2013
Phase
Phase 1
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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy people
  • aged between 20 and 50 years
  • BMI between 27 and 29 kg/m2
  • without metabolic syndrome
  • no pregnant nor nursing women
  • covered by Social Security
Show all 10Show fewer
  • negative serology for hepatitis B/C and HIV
  • who signed the informed consent form
  • subjects receiving over 4,500 Euros in the last 12 months (including the present study)
  • subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

Who cannot join

  • persons abusing drugs (laxatives, anti-diarrheal, agents acting on satiety)
  • person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
  • person intolerant to gluten and / or allergic to wheat flour
  • person in diet during the last 3 months
  • person in vegetarian or vegan diet
  • person who donated blood during the 3 months preceding the study

Trial locations and contacts

1 site in 1 country.

France1 site

  • CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier

    Bondy, Seine-Saint-Denis, 93143

Other trials in France

About this study

Official title: Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.

The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.

Conditions
Overweight
Being tested
NUTRIOSE FB06, GLUCIIDEX 21
Keywords
overweight, satiety, functional food, food intake, digestive tolerance
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUTRIOSE FB06Dietary supplement

    14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day

  • GLUCIIDEX 21Dietary supplement

    7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day

Study groups in NCT01897662
Study groupRoleWhat they receive
NUTRIOSEExperimentalGroup of volunteers fed with NUTRIOSE
Receives: Dietary Supplement: NUTRIOSE FB06
GLUCIDEXActive comparatorGroup of volunteers fed with GLUCIDEX
Receives: Dietary Supplement: GLUCIIDEX 21

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    Measured: D-7; D28; D56; D84

Secondary outcomes (15)

  1. satiety

    Measured: D-7; D28; D56; D84

  2. energy intake

    Measured: D-7; D28; D56; D84

  3. BMI

    Body Mass Index

    Measured: D-7; D28; D56; D84

  4. body fat

    measured by DEXA

    Measured: D-7; D28; D56; D84

  5. waist size

    Measured: D-7; D28; D56; D84

  6. glycemia

    Measured: D-7; D28; D56; D84

  7. insulinemia

    Measured: D-7; D28; D56; D84

  8. total cholesterol

    Measured: D-7; D28; D56; D84

  9. LDL cholesterol

    Measured: D-7; D28; D56; D84

  10. HDL cholesterol

    Measured: D-7; D28; D56; D84

  11. triglyceridemia

    Measured: D-7; D28; D56; D84

  12. HOMA

    homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion)

    Measured: D-7; D28; D56; D84

  13. microbiota

    measured by RT-PCR

    Measured: D-7; D28; D56; D84

  14. blood pressure

    Measured: D-7; D28; D56; D84

  15. digestive tolerance

    measured with daily questionnaires

    Measured: D-7; D28; D56; D84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

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 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897662
Sponsor's protocol ID
ROQ_NUTRIMETAB10
Other IDs
2011-A00062-39
Acronym
ROQ_NUTRIMETAB
Status last verified
Jul 2013
First submitted
9 Jul 2013
Last updated
12 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

    PubMed 21164548

  • Slavin JL, Savarino V, Paredes-Diaz A, Fotopoulos G. A review of the role of soluble fiber in health with specific reference to wheat dextrin. J Int Med Res. 2009 Jan-Feb;37(1):1-17. doi: 10.1177/147323000903700101.

    PubMed 19215668

  • Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE(R) dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

    PubMed 21591985

  • Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24. doi: 10.1128/AEM.71.5.2318-2324.2005.

    PubMed 15870317

  • Suzuki K, Simpson KA, Minnion JS, Shillito JC, Bloom SR. The role of gut hormones and the hypothalamus in appetite regulation. Endocr J. 2010;57(5):359-72. doi: 10.1507/endocrj.k10e-077. Epub 2010 Apr 14.

    PubMed 20424341

  • Ruskone-Fourmestraux A, Attar A, Chassard D, Coffin B, Bornet F, Bouhnik Y. A digestive tolerance study of maltitol after occasional and regular consumption in healthy humans. Eur J Clin Nutr. 2003 Jan;57(1):26-30. doi: 10.1038/sj.ejcn.1601516.

    PubMed 12548293

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NUTRIOSE FB06 and GLUCIIDEX 21 in people with Overweight, run by Nealth Sarl at 1 site in France.

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 10 inclusion and 6 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 12 Jul 2013. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

body weight (time frame: D-7; D28; D56; D84). 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 NCT01897662, which also lists 6 linked publications.

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 12 Jul 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in