Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

NCT05372666 | Completed

• 1 other identifier: Qualista-IG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Glycaemic index

  percentage area under the curve compared to standard white bread as 100% reference

  glycemia measured over 120 minutes

Study Arms (7)

Control IG100

PLACEBO COMPARATOR

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

Other: Standard white bread

Reference WB

EXPERIMENTAL

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

Other: Experimental white bread

Reference HFB

ACTIVE COMPARATOR

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

Qualista HFB 01

EXPERIMENTAL

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

Qualista HFB 02

EXPERIMENTAL

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

Qualista HFB 03

EXPERIMENTAL

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

Qualista HFB 04

EXPERIMENTAL

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

Interventions

Standard white bread OTHER

Bread to be consumed within 10 minutes after 10h fasting

Control IG100

Experimental white bread OTHER

Bread to be consumed within 10 minutes after 10h fasting

Reference WB

Standard High-fiber bread OTHER

Bread to be consumed within 10 minutes after 10h fasting

Reference HFB

Experimental High-fiber bread OTHER

Bread to be consumed within 10 minutes after 10h fasting

Qualista HFB 01; Qualista HFB 02; Qualista HFB 03; Qualista HFB 04

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 deprived of liberty or under judicial protection

Sponsors & Collaborators

• Paulic Meunerie SA: lead
• Institut Polytechnique UniLaSalle: collaborator

Study Sites (1)

Centre de recherche clinique - Centre Hospitalo Universitaire

Amiens, 80000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: June 1, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

FR (1)