HealthyNCT05372666
Glycaemic Index of Fibre-rich Flours in Healthy Volunteers
A study testing Standard white bread, Experimental white bread and Standard High-fiber bread in people with Healthy, run by Paulic Meunerie SA at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard white bread, Experimental white bread and Standard High-fiber bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 8 Nov 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de recherche clinique - Centre Hospitalo Universitaire
Amiens, 80000
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Standard white bread, Experimental white bread, Standard High-fiber bread, Experimental High-fiber bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard white breadOther
Bread to be consumed within 10 minutes after 10h fasting
Experimental white breadOther
Bread to be consumed within 10 minutes after 10h fasting
Standard High-fiber breadOther
Bread to be consumed within 10 minutes after 10h fasting
Experimental High-fiber breadOther
Bread to be consumed within 10 minutes after 10h fasting
| Study group | Role | What they receive |
|---|---|---|
| Control IG100 | Placebo comparator | 1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates Receives: Other: Standard white bread |
| Reference WB | Experimental | 1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates Receives: Other: Experimental white bread |
| Reference HFB | Active comparator | 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 Receives: Other: Standard High-fiber bread |
| Qualista HFB 01 | Experimental | 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 Receives: Other: Experimental High-fiber bread |
| Qualista HFB 02 | Experimental | 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 Receives: Other: Experimental High-fiber bread |
| Qualista HFB 03 | Experimental | 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 Receives: Other: Experimental High-fiber bread |
| Qualista HFB 04 | Experimental | 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 Receives: Other: Experimental High-fiber bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index
percentage area under the curve compared to standard white bread as 100% reference
Measured: glycemia measured over 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Jun 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Latin square randomization for test products following reference treatment (as per standard protocol)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulic Meunerie SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique UniLaSalle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372666
- Sponsor's protocol ID
- Qualista-IG
- Status last verified
- Mar 2023
- First submitted
- 9 May 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05372666
- Acronym / sponsor ID
- Qualista-IG
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Paulic Meunerie SAIndustry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique UniLaSalle
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 13 May 2022 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Latin square randomization for test products following reference treatment (as per standard protocol)
| Arm | Type | Receives |
|---|---|---|
| Control IG100 | Placebo comparator | Other: Standard white bread1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates |
| Reference WB | Experimental | Other: Experimental white bread1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates |
| Reference HFB | Active comparator | Other: Standard High-fiber bread1 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 |
| Qualista HFB 01 | Experimental | Other: Experimental High-fiber bread1 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 |
| Qualista HFB 02 | Experimental | Other: Experimental High-fiber bread1 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 |
| Qualista HFB 03 | Experimental | Other: Experimental High-fiber bread1 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 |
| Qualista HFB 04 | Experimental | Other: Experimental High-fiber bread1 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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 %
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 |
|---|---|---|
| Standard white breadBread to be consumed within 10 minutes after 10h fasting | Other | Control IG100 |
| Experimental white breadBread to be consumed within 10 minutes after 10h fasting | Other | Reference WB |
| Standard High-fiber breadBread to be consumed within 10 minutes after 10h fasting | Other | Reference HFB |
| Experimental High-fiber breadBread to be consumed within 10 minutes after 10h fasting | Other | Qualista HFB 01, Qualista HFB 02, Qualista HFB 03, Qualista HFB 04 |
Primary outcome
Glycaemic index
Time frame: glycemia measured over 120 minutes
percentage area under the curve compared to standard white bread as 100% reference
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 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard white bread, Experimental white bread and Standard High-fiber bread in people with Healthy, run by Paulic Meunerie SA 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 5 inclusion and 13 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 28 Mar 2023. 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. 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?
Glycaemic index (time frame: glycemia measured over 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.