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
Measure Time Frame
Glycaemic index glycemia measured over 120 minutes
Enrollment 20
Condition
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]

Location
Facility: Status: Contact: Investigator: Centre de recherche clinique - Centre Hospitalo Universitaire Laurence LEPILLIEZ [email protected] Sandrine SORIOT-THOMAS, MD Principal Investigator
Location Countries

France

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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