Clinical trial NCT05306106: Glycemic Index of Pastry
Official title: Determination of the Glycemic Index of Pastry. A Randomized Study on Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: pastry
glycemic index
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: monocentric, randomized, cross-over and ambulatory study
Primary purpose: OTHER

Brief summary: In the early 1980s and following the first publications by Jenkins et al., The notion of glycemic index (GI) appeared with the aim of classifying the different sources of carbohydrates in our diet according to their effect on the post-prandial glycemic response. Since these years, many studies have been designed to determine the usefulness of the glycemic index and indicate that a low glycemic index for a food, a dish, a meal or a diet is associated with a decreased risk of metabolic pathologies (diabetes, hypertriglyceridemia), degenerative (cardiovascular diseases) or overload (obesity). This justifies the interest in favoring foods with a low glycemic index in healthy subjects.

A review confirmed the mechanistic link between postprandial blood sugar and the variability of blood sugar, making it possible, on the one hand, to maintain good glucose homeostasis and, on the other hand, to prevent pathologies such as obesity, diabetes and cardio-vascular diseases. The EFSA also considers that reducing the increase in blood sugar in the post-meal phase can be considered a physiological benefit, especially in subjects with glucose intolerance.

Post-meal blood sugar depends on many factors including the glycemic index of foods eaten during the meal. Knowing the glycemic index of foods is therefore very useful.

Mademoiselle Dessert offers pastries with a low glycemic index. The objective of this study is thus to determine the glycemic index of 6 pastries in order to inform consumers on these pastries glycemic index.

Detailed description: The study will be carried out on healthy volunteers, aged from 18 to 65 with a body mass index (BMI) between 18 and 30 kg/m² (limits included).

The main objective of the study is to determine the glycemic index of 6 pastries in healthy volunteers with 7 kinetic points (0, 15, 30, 45, 60, 90 and 120 min).

Eligibility criteria: Inclusion Criteria:

* Man or woman ;
* Aged 18 to 65 (limits included);
* Having a body mass index (BMI) between 18 and 30 kg / m² (limits included);
* Agreeing to maintain their lifestyle (sport and diet) for the duration of the study;
* Agreeing not to smoke on the morning of each visit (before and during the visit).

Exclusion Criteria:

* Fasting blood glucose ≥ 6.1 mmol / L (or 1.10 g / L);
* Fasting triglycerides ˃ 2 g / L;
* Hyperinsulinemia (20 mIU / L) or history of insulinoma;
* Elevation of transaminases beyond 2x the upper limit;
* Subject presenting episodes of functional post-meal hypoglycaemia;
* Diabetic subject whether or not treated;
* Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating);
* Subject presenting an immunodeficiency or any other serious pathology (cancer, hemopathy);
* Subject with a history of hypercholesterolemia and high blood pressure;
* Subject with renal failure;
* Subject with an allergy / intolerance to one of the constituents of the products under study;
* Subject with an intestinal pathology likely to modify digestion or absorption (Crohn's disease, etc.);
* Subject consuming more than 3 glasses of alcohol per day for men and more than 2 glasses per day for women;
* Subject not having a stable weight for the last 3 months (± 5%);
* Woman pregnant or planning to be during the study period, breastfeeding woman.

Primary outcomes:
measure: Glycemia: 7-point kinetics
timeFrame: 0 min
measure: Glycemia: 7-point kinetics
timeFrame: 15 min
measure: Glycemia: 7-point kinetics
timeFrame: 30 min
measure: Glycemia: 7-point kinetics
timeFrame: 45 min
measure: Glycemia: 7-point kinetics
timeFrame: 60 min
measure: Glycemia: 7-point kinetics
timeFrame: 90 min
measure: Glycemia: 7-point kinetics
timeFrame: 120 min
Secondary outcomes:
measure: Peak blood sugar (Cmax-Gly)
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min
measure: The time to onset of the blood sugar peak (Tmax-Gly)
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min
measure: Insulin index
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min
measure: Peak insulinemia (Cmax-Ins)
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min
measure: The time to onset of peak insulinemia (Tmax-Ins)
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel LECERF, MD
role: PRINCIPAL_INVESTIGATOR
References: