Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

March 27, 2023 updated by: Paulic Meunerie SA

Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers

The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.

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.
20

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.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
        • Centre de recherche clinique - Centre Hospitalo Universitaire

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a Body Mass Index (BMI) between 18.5 and 30 kg/m²
  • Non-smoker for more than three months
  • Having signed the informed consent form
  • Likely to follow the constraints generated by the study (one morning per week for 9 weeks)
  • Social insurance

Exclusion Criteria:

  • Pregnant woman
  • Subject with a known progressive somatic or psychiatric disease
  • Fasting blood glucose greater than 6.1 mmol/L (1.10 g/L), postprandial blood glucose greater than 7.7 mmol/L (1.4 g/L) or known diabetes treated or untreated
  • Hyperinsulinemia or a history of insulinoma
  • HbA1c greater than 7 %
  • History of hypercholesterolemia, hypertension, diabetes or glucose intolerance
  • History of food allergy or digestive pathology likely to affect digestion or absorption
  • Renal failure
  • ASAT or ALAT elevation beyond 1.5 times the upper limit
  • Subject consuming more than three glasses per day of alcohol or suffering from various addictions
  • Weight change of more than 3 kg in the last three months
  • Person participating in another clinical study, or in a period of exclusion from another study
  • Person deprived of liberty or under judicial protection

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

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.
Placebo Comparator: Control IG100
1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates
Other: Standard white bread
Bread to be consumed within 10 minutes after 10h fasting
Experimental: Reference WB
1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates
Other: Experimental white bread
Bread to be consumed within 10 minutes after 10h fasting
Active Comparator: Reference HFB
1 small bread loaf using T55 standard white flour supplemented with 11 % standard wheat bran (6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates
Other: Standard High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting
Experimental: Qualista HFB 01
1 small bread loaf using T55 Qualista white flour supplemented with 13 % untreated Qualista wheat bran (6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates
Other: Experimental High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting
Experimental: Qualista HFB 02
1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment A - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates
Other: Experimental High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting
Experimental: Qualista HFB 03
1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment B - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates
Other: Experimental High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting
Experimental: Qualista HFB 04
1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment C - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates
Other: Experimental High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting

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
Measure Description
Time Frame
Glycaemic index
Time Frame: glycemia measured over 120 minutes
percentage area under the curve compared to standard white bread as 100% reference
glycemia measured over 120 minutes

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.
Paulic Meunerie SA

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.
Institut Polytechnique UniLaSalle

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 (Actual)

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, 2022

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.
November 8, 2022

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.
November 8, 2022

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).
May 9, 2022

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.
May 9, 2022

First Posted (Actual)

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.
May 13, 2022

Study Record Updates

Last Update Posted (Actual)

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.
March 28, 2023

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.
March 27, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • Qualista-IG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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