Healthy VolunteersIG-DESSERTNCT05306106

Glycemic Index of Pastry

A study testing Glucose, truffle match and hazelnut chocolate cookie in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Glucose, truffle match and hazelnut chocolate cookie
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteFrance
Study dates: 6 Apr 2021to 6 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

France1 site

NutrInvest - Institut Pasteur de Lille
Lille, Nord, 59019

Other trials in France

About this study

Official title: Determination of the Glycemic Index of Pastry. A Randomized Study on Healthy Volunteers.

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.

Read the 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).

Conditions: Healthy Volunteers
Being tested: Glucose, truffle match, hazelnut chocolate cookie, Paris Brest style eclair, hazelnut chocolate finger
Keywords: pastry, glycemic index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlucoseOther
Each subject will consume the reference product during visits V1 and V5. A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume the glucose solution. The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
truffle matchOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 221.2 g of truffle match (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
hazelnut chocolate cookieOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 142.8 g of hazelnut chocolate cookie (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
Paris Brest style eclairOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 277.7 g of Paris Brest style eclair (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
hazelnut chocolate fingerOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 312.5 g of hazelnut chocolate finger (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
lemon fingerOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 263.1 g of lemon finger (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.
elderflower madeleineOther
The products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list.
During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 294.1 g of elderflower madeleine (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.

Study groups in NCT05306106
Study group	Role	What they receive
Glucose	Other	The control product, said to be the reference product, is an oral solution of 50 g of glucose. Receives: Other: Glucose
a truffle match	Other	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. Receives: Other: truffle match
a hazelnut chocolate cookie	Other	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. Receives: Other: hazelnut chocolate cookie
a Paris Brest style eclair	Other	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. Receives: Other: Paris Brest style eclair
a hazelnut chocolate finger	Other	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. Receives: Other: hazelnut chocolate finger
a lemon finger	Other	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. Receives: Other: lemon finger
a elderflower madeleine	Other	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. Receives: Other: elderflower madeleine

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycemia: 7-point kinetics
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
Measured: 0 min
Glycemia: 7-point kinetics
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
Measured: 15 min
Glycemia: 7-point kinetics
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
Measured: 30 min
Glycemia: 7-point kinetics
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
Measured: 45 min
Glycemia: 7-point kinetics
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
Measured: 60 min
Glycemia: 7-point kinetics
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
Measured: 90 min
Glycemia: 7-point kinetics
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
Measured: 120 min

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 20216 Jul 2021

First posted31 Mar 2022
Study start6 Apr 2021
Primary completion6 Jul 2021
Study completion6 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: monocentric, randomized, cross-over and ambulatory study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05306106
Sponsor's protocol ID: 2020-A03161-38
Acronym: IG-DESSERT
Status last verified: Mar 2022
First submitted: 11 Oct 2021
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of the Glycemic Index of Pastry. A Randomized Study on Healthy Volunteers.
ClinicalTrials.gov ID: NCT05306106
Acronym / sponsor ID: IG-DESSERT / 2020-A03161-38
Conditions: Healthy Volunteers
Keywords: pastry, glycemic index
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Institut Pasteur de LilleUniversity, hospital or other
Study start: 6 Apr 2021 (actual)
Primary completion: 6 Jul 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 31 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 7
Model description: monocentric, randomized, cross-over and ambulatory study

Arm	Type	Receives
Glucose	Other	Other: GlucoseThe control product, said to be the reference product, is an oral solution of 50 g of glucose.
a truffle match	Other	Other: truffle matchThe 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	Other	Other: hazelnut chocolate cookieThe 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	Other	Other: Paris Brest style eclairThe 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	Other	Other: hazelnut chocolate fingerThe 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 lemon finger	Other	Other: lemon fingerThe 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	Other	Other: elderflower madeleineThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlucoseEach subject will consume the reference product during visits V1 and V5. A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume the glucose solution. The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	Glucose
truffle matchThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 221.2 g of truffle match (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a truffle match
hazelnut chocolate cookieThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 142.8 g of hazelnut chocolate cookie (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a hazelnut chocolate cookie
Paris Brest style eclairThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 277.7 g of Paris Brest style eclair (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a Paris Brest style eclair
hazelnut chocolate fingerThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 312.5 g of hazelnut chocolate finger (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a hazelnut chocolate finger
lemon fingerThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 263.1 g of lemon finger (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a lemon finger
elderflower madeleineThe products evaluated are pastries from the Mademoiselle Desserts range. The amounts consumed will be calculated for each of the pastries so that 50 g of carbohydrate is ingested per intake. Subjects may consume 200 mL of water after ingesting the pastries. During visits V2 to V4 and V6 to V8, the subject will consume successively the pastries which will have been assigned to him randomly and according to the randomization list. During the visit : A venous catheter will be placed by a medical biology technician and a blood sample will be taken immediately after placement: this is the first sample at T = 0 min. Then, the subject will have a maximum of 10 minutes to consume 294.1 g of elderflower madeleine (contained 50 g of glucose). The technician will then take blood samples at T = 15, T = 30, T = 45, T = 60, T = 90 and T = 120 minutes.	Other	a elderflower madeleine

Primary outcome

Glycemia: 7-point kinetics
Time frame: 0 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
Glycemia: 7-point kinetics
Time frame: 15 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
Glycemia: 7-point kinetics
Time frame: 30 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
Glycemia: 7-point kinetics
Time frame: 45 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
Glycemia: 7-point kinetics
Time frame: 60 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
Glycemia: 7-point kinetics
Time frame: 90 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
Glycemia: 7-point kinetics
Time frame: 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

5 secondary outcomes

Peak blood sugar (Cmax-Gly)
Time frame: 0, 15, 30, 45, 60, 90 and 120 min
The time to onset of the blood sugar peak (Tmax-Gly)
Time frame: 0, 15, 30, 45, 60, 90 and 120 min
Insulin index
Time frame: 0, 15, 30, 45, 60, 90 and 120 min
Peak insulinemia (Cmax-Ins)
Time frame: 0, 15, 30, 45, 60, 90 and 120 min
The time to onset of peak insulinemia (Tmax-Ins)
Time frame: 0, 15, 30, 45, 60, 90 and 120 min

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Individual participant dataSharing planned: Undecided

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Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Michel LECERF, MD principal investigator

Institut Pasteur de Lille - NutrInvest

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Glucose, truffle match and hazelnut chocolate cookie in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemia: 7-point kinetics (time frame: 0 min). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05306106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.