Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota. (ROQ_NUTRIFLORE)

July 9, 2013 updated by: Nealth Sarl

Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.

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." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93009
        • Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 20 to 50 years,
  • BMI 18 to 25 kg/m2,
  • absence of known or scalable organic or psychiatric disease
  • no history of chronic gastrointestinal disease
  • having a bowel regularity (1-3 defecation per day, of normal consistency),
  • person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women)
  • having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine)
  • 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)
  • 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 vegetarian or vegan diet
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NUTRIOSE
group of volunteers fed with NUTRIOSE
Dietary supplement: NUTRIOSE FB06
15g/day NUTRIOSE FB06
Active Comparator: GLUCIDEX
gruop of volunteers fed with GLUCIDEX
Dietary supplement: GLUCIDEX 21
15g/day GLUCIDEX 21

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clostridium Perfringens rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
digestive tolerance
Time Frame: J0 to J28 (every day)
J0 to J28 (every day)
stool pH
Time Frame: D0 ; D14; D28
D0 ; D14; D28
total stool flora
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Bacteroides rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Eubacterium rectal rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Clostridium coccoides rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Clostridium leptum rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Bifidobacteria rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Lactobacteria rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Streptococcus rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Enterococcus rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Bacteroidetes rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Actinobacteria rate in stool
Time Frame: D0 ; D14; D28
D0 ; D14; D28
Firmicutes rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
E. Coli rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Clostridium difficile rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Faecalibacterium prausnitzii rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Clostridium difficile typa A and B rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
E. Coli EIEC + EPEC (eae gene) rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Shigella + E. Coli EIEC (ipaH gene) rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Listeria Monocytogenes rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28
Yersinia Enterocolitica rate in stool
Time Frame: D0 ; D14 ; D28
D0 ; D14 ; D28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nealth Sarl

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roquette Frères

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert BENAMOUZIG, MD,PhD, Centre de Recherche en Nutrition Humaine d'Ile-de-France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROQ_NUTRIFLORE10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings