Glycemic Index of Pastry

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Glucose; Other: lemon finger; Other: Paris Brest style eclair; Other: truffle match; Other: hazelnut chocolate cookie; Other: elderflower madeleine; Other: hazelnut chocolate finger

• Registration Number: NCT05306106
• Lead Sponsor: Institut Pasteur de Lille

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).

Study Timeline

• Study Start: 2021-04-06
• Primary Completion: 2021-07-06
• Study Completion: 2021-07-06
• Study First Submitted: 2021-10-11
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose	Glucose	The control product, said to be the reference product, is an oral solution of 50 g of glucose.
a lemon finger	lemon finger	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.
a Paris Brest style eclair	Paris Brest style eclair	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.
a truffle match	truffle match	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.
a hazelnut chocolate cookie	hazelnut chocolate cookie	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.
a elderflower madeleine	elderflower madeleine	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.
a hazelnut chocolate finger	hazelnut chocolate finger	The products evaluated are pastries from the Mademoiselle Desserts range, namely a truffle match, a hazelnut chocolate cookie, a Paris Brest style eclair, a hazelnut chocolate finger, a lemon finger and an elderflower madeleine.

Primary Outcome Measures

Name	Time	Method
Glycemia: 7-point kinetics	120 min	Blood glucose kinetics over 2 hours, performed from 7 blood samples and at 7 different times: T = 0, T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 min, on each test product and on the reference product (glucose).; Visits V1 to V8

Secondary Outcome Measures

Name	Time	Method
Insulin index	0, 15, 30, 45, 60, 90 and 120 min	For each product and from the glycemia and insulinemia dosage curves: insulin index Visits V1 to V8
Peak blood sugar (Cmax-Gly)	0, 15, 30, 45, 60, 90 and 120 min	For each product and from the glycemia and insulinemia dosage curves: peak blood sugar (Cmax-Gly).; Visits V1 to V8
The time to onset of the blood sugar peak (Tmax-Gly)	0, 15, 30, 45, 60, 90 and 120 min	For each product and from the glycemia and insulinemia dosage curves: the time to onset of the blood sugar peak (Tmax-Gly). Visits V1 to V8
Peak insulinemia (Cmax-Ins)	0, 15, 30, 45, 60, 90 and 120 min	For each product and from the glycemia and insulinemia dosage curves: peak insulinemia (Cmax-Ins).; Visits V1 to V8
The time to onset of peak insulinemia (Tmax-Ins)	0, 15, 30, 45, 60, 90 and 120 min	For each product and from the glycemia and insulinemia dosage curves: the time to onset of peak insulinemia (Tmax-Ins). Visits V1 to V8

Trial Locations

Locations (1)

NutrInvest - Institut Pasteur de Lille; 🇫🇷 Lille, Nord, France