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OpenTrials
Completed

NCT Number: NCT05372666

Glycaemic Index of Fibre-rich Flours 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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche clinique - Centre Hospitalo Universitaire

Amiens, 80000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard white bread

Other

Bread to be consumed within 10 minutes after 10h fasting

Experimental white bread

Other

Bread to be consumed within 10 minutes after 10h fasting

Standard High-fiber bread

Other

Bread to be consumed within 10 minutes after 10h fasting

Experimental High-fiber bread

Other

Bread to be consumed within 10 minutes after 10h fasting

Primary outcomes

  1. Glycaemic index

    Time frame: glycemia measured over 120 minutes

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

Sponsors and collaborators

Lead sponsor

Paulic Meunerie SA

Industry

Collaborators

  • Institut Polytechnique UniLaSalle

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 13, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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