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Completed

NCT Number: NCT01897662

Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity 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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Bondy, Seine-Saint-Denis, 93143, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • negative serology for hepatitis B/C and HIV
  • who signed the informed consent form

Exclusion criteria

  • 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
  • Inclusion in another clinical study
  • 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.

Treatment and study plan

Nutriose FB06

Dietary Supplement

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

GLUCIIDEX 21

Dietary Supplement

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

Primary outcomes

  1. body weight

    Time frame: D-7; D28; D56; D84

Secondary outcomes

  1. satiety

    Time frame: D-7; D28; D56; D84

  2. energy intake

    Time frame: D-7; D28; D56; D84

  3. BMI

    Time frame: D-7; D28; D56; D84

    Body Mass Index

  4. body fat

    Time frame: D-7; D28; D56; D84

    measured by DEXA

  5. waist size

    Time frame: D-7; D28; D56; D84

  6. glycemia

    Time frame: D-7; D28; D56; D84

  7. insulinemia

    Time frame: D-7; D28; D56; D84

  8. total cholesterol

    Time frame: D-7; D28; D56; D84

  9. LDL cholesterol

    Time frame: D-7; D28; D56; D84

  10. HDL cholesterol

    Time frame: D-7; D28; D56; D84

  11. triglyceridemia

    Time frame: D-7; D28; D56; D84

  12. HOMA

    Time frame: D-7; D28; D56; D84

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

  13. microbiota

    Time frame: D-7; D28; D56; D84

    measured by RT-PCR

  14. blood pressure

    Time frame: D-7; D28; D56; D84

  15. digestive tolerance

    Time frame: D-7; D28; D56; D84

    measured with daily questionnaires

Sponsors and collaborators

Lead sponsor

Nealth Sarl

Network

Collaborators

  • Roquette Freres

Registry information

Official study title

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

Acronym: ROQ_NUTRIMETAB

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2013
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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