Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372666
• Other study ID #: Qualista-IG
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: March 2023
• Source: Paulic Meunerie SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Standard white bread
Bread to be consumed within 10 minutes after 10h fasting
• Experimental white bread
Bread to be consumed within 10 minutes after 10h fasting
• Standard High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting
• Experimental High-fiber bread
Bread to be consumed within 10 minutes after 10h fasting

Locations

Country	Name	City	State
France	Centre de recherche clinique - Centre Hospitalo Universitaire	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Paulic Meunerie SA	Institut Polytechnique UniLaSalle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic index	percentage area under the curve compared to standard white bread as 100% reference	glycemia measured over 120 minutes