Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Standard white bread
* Other: Experimental white bread
* Other: Standard High-fiber bread
* Other: Experimental High-fiber bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Latin square randomization for test products following reference treatment (as per standard protocol)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control IG100<br>1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates | Other: Standard white bread<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Experimental: Reference WB<br>1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates | Other: Experimental white bread<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Active Comparator: Reference HFB<br>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<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Experimental: Qualista HFB 01<br>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<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Experimental: Qualista HFB 02<br>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<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Experimental: Qualista HFB 03<br>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<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|
| Experimental: Qualista HFB 04<br>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<br>* Bread to be consumed within 10 minutes after 10h fasting<br>|

What is the study measuring?
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Primary Outcome Measures

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