Glycaemic Index of Fibre-rich Flours in Healthy Volunteers
Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers
| Sponsors |
Lead Sponsor: Paulic Meunerie SA Collaborator: Institut Polytechnique UniLaSalle |
|---|---|
| Source | Paulic Meunerie SA |
| Brief 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. |
| Overall Status | Recruiting | ||||
|---|---|---|---|---|---|
| Start Date | 2022-05-01 | ||||
| Completion Date | 2022-12-01 | ||||
| Primary Completion Date | 2022-11-01 | ||||
| Phase | N/A | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 20 |
| Condition | |
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| Intervention |
Intervention Type: Other Intervention Name: Standard white bread Description: Bread to be consumed within 10 minutes after 10h fasting Arm Group Label: Control IG100 Intervention Type: Other Intervention Name: Experimental white bread Description: Bread to be consumed within 10 minutes after 10h fasting Arm Group Label: Reference WB Intervention Type: Other Intervention Name: Standard High-fiber bread Description: Bread to be consumed within 10 minutes after 10h fasting Arm Group Label: Reference HFB Intervention Type: Other Intervention Name: Experimental High-fiber bread Description: Bread to be consumed within 10 minutes after 10h fasting |
| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: 40 Years Healthy Volunteers: Accepts Healthy Volunteers |
| Overall Contact |
Last Name: Flore DEPEINT, PhD Phone: +33 344067592 Email: [email protected] |
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| Location |
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| Location Countries |
France |
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| Verification Date |
2022-05-01 |
| Responsible Party |
Type: Sponsor |
| Has Expanded Access | No |
| Number Of Arms | 7 |
| Arm Group |
Label: Control IG100 Type: Placebo Comparator Description: 1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates Label: Reference WB Type: Experimental Description: 1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates Label: Reference HFB Type: Active Comparator Description: 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 Label: Qualista HFB 01 Type: Experimental Description: 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 Label: Qualista HFB 02 Type: Experimental Description: 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 Label: Qualista HFB 03 Type: Experimental Description: 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 Label: Qualista HFB 04 Type: Experimental Description: 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 |
| Patient Data | Undecided |
| Study Design Info |
Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Latin square randomization for test products following reference treatment (as per standard protocol) Primary Purpose: Other Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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