Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers

Mondelez International

Status: Completed

Conditions: Insulinemia; Glycaemia

Treatments: Other: Food Product D: Crackers Nature; Other: Food Product E: Breakfast Biscuit; Other: Reference Glucose; Other: Food Product F: White Bread; Other: Food Product A: Corn Flakes; Other: Food Product B: Ginger Bread; Other: Food Product C:Sandwiched Breakfast Biscuit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01870570

KBE019

Details and patient eligibility

About

The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

Full description

This study will be performed at 3 centers and 15 subjects will be recruited at each center.

Enrollment: 48 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 18-35 years inclusive.

2. Non-smoker.

3. BMI 19.0-25.0 kg/m2 inclusive.

4. Healthy subjects with:

   • Fasting plasma glucose < 5,6 mM (ADA criteria,2011)
   • Insulin resistance index based on homeostasis model assessment (HOMA-IR) <1.70
   • Fasting lipids: triglyceride <1.70mmol/L, LDL-cholesterol<5.00 mmol/L and HDL-cholesterol >1.03mmol/L for males or >1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
   • Gamma-GT, AST and ALT <1.5 times the upper limit of normal (ULN)
   • Complete blood count: Normal full blood count according to the investigator
   • Systolic blood pressure <130 mmHg
   • Diastolic blood pressure <85 mmHg
   • Resting heart rate 50-90 beats per minutes (after 3 minutes rest).

5. Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.

6. Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))

7. Able to fast for at least 10 hours the night before each test session.

8. Able to refrain from eating legumes and drinking alcohol the day before each test session.

9. Subject covered by social security or covered by a similar system

10. Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits

11. Subject having given written consent to take part in the study

Exclusion criteria

1. Following a restrictive or specific diet.
2. Suffering from any inflammatory or metabolic diseases
3. Suffering from mental illness.
4. Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
5. Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
6. Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
7. Subject having taken part in another clinical trial within the last week.
8. Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
9. Subject undergoing general anaesthesia in the month prior to inclusion.
10. Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 7 patient groups

Reference Glucose

Other group

Description:

Glucose Standard (50g of Glucose)

Treatment:

Other: Reference Glucose

Food Product A: Corn Flakes

Experimental group

Description:

Corn Flakes

Treatment:

Other: Food Product A: Corn Flakes

Food Product B: Ginger Bread

Experimental group

Description:

Ginger Bread

Treatment:

Other: Food Product B: Ginger Bread

Food Product C:Sandwiched Breakfast Biscuit

Experimental group

Description:

Sandwiched Breakfast Biscuit

Treatment:

Other: Food Product C:Sandwiched Breakfast Biscuit

Food Product D: Crackers Nature

Experimental group

Description:

Crackers Nature

Treatment:

Other: Food Product D: Crackers Nature

Food Product E: Breakfast Biscuit

Experimental group

Description:

Breakfast Biscuit

Treatment:

Other: Food Product E: Breakfast Biscuit

Food Product F: White Bread

Experimental group

Description:

White Bread

Treatment:

Other: Food Product F: White Bread