Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

Sponsor

Paulic Meunerie SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05372666

Collaborator

Institut Polytechnique UniLaSalle (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Standard white bread Other: Experimental white bread Other: Standard High-fiber bread Other: Experimental High-fiber bread	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Latin square randomization for test products following reference treatment (as per standard protocol)Latin square randomization for test products following reference treatment (as per standard protocol)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Glycaemic index [glycemia measured over 120 minutes]
percentage area under the curve compared to standard white bread as 100% reference

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de recherche clinique - Centre Hospitalo Universitaire	Amiens		France	80000

Sponsors and Collaborators

Paulic Meunerie SA
Institut Polytechnique UniLaSalle

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paulic Meunerie SA

ClinicalTrials.gov Identifier:

NCT05372666

Other Study ID Numbers:

Qualista-IG

First Posted:

May 13, 2022

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 13, 2022