Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

Paulic Meunerie

Status: Completed

Conditions: Healthy

Treatments: Other: Experimental High-fiber bread; Other: Standard white bread; Other: Experimental white bread; Other: Standard High-fiber bread

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05372666

Qualista-IG

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

20 participants in 7 patient groups, including a placebo group

Control IG100

Placebo Comparator group

Description:

1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates

Treatment:

Other: Standard white bread

Reference WB

Experimental group

Description:

1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates

Treatment:

Other: Experimental white bread

Reference HFB

Active Comparator group

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

Treatment:

Other: Standard High-fiber bread

Qualista HFB 01

Experimental group

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

Treatment:

Other: Experimental High-fiber bread

Qualista HFB 02

Experimental group

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

Treatment:

Other: Experimental High-fiber bread

Qualista HFB 03

Experimental group

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

Treatment:

Other: Experimental High-fiber bread

Qualista HFB 04

Experimental group

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

Treatment:

Other: Experimental High-fiber bread