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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Standard white bread; Other: Experimental white bread; Other: Standard High-fiber bread; Other: Experimental High-fiber bread

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Paulic Meunerie SA
• Collaborators: Institut Polytechnique UniLaSalle

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID 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