Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products

Mondelez International

Status: Completed

Conditions: Metabolic Disorder

Treatments: Other: Product E: NP-0152; Other: Product D: NP-0151; Other: Glucose solution; Other: Product A: NP-0148; Other: Product B: NP-0149; Other: Product C: NP-0150

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02650674

KBE043

Details and patient eligibility

About

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.

Full description

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 18-45 years.
• Non-smoker.
• BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
• Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
• Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
• Healthy subjects with:

Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).

• Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
• 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))
• Able to fast for at least 10 hours the night before each test session.
• Able to refrain from eating legumes and drinking alcohol the day before each test session.
• Subject covered by social security or covered by a similar system
• Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
• Subject having given written consent to take part in the study.

Exclusion criteria

• Following a restrictive diet.
• Family history of Diabetes Mellitus or obesity
• Suffering from any clinical, physical or mental illness.
• Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
• Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
• Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
• Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
• Subject having taken part in another clinical trial within the last week.
• Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
• Subject undergoing general anaesthesia in the month prior to inclusion.
• 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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24 participants in 6 patient groups

Product A: NP-0148

Experimental group

Description:

Cereal product belVita Milk \& Cereals - High in SDS

Treatment:

Other: Product A: NP-0148

Product B: NP-0149

Experimental group

Description:

Cereal product belVita Honey \& Nuts - High in SDS

Treatment:

Other: Product B: NP-0149

Product C: NP-0150

Experimental group

Description:

Cereal product belVita Mixed Berry - High in SDS

Treatment:

Other: Product C: NP-0150

Product D: NP-0151

Experimental group

Description:

Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat

Treatment:

Other: Product D: NP-0151

Product E: NP-0152

Experimental group

Description:

Cereal product Kellogg's Trésor Duo Choco - Low in SDS

Treatment:

Other: Product E: NP-0152

Glucose reference

Experimental group

Description:

Glucose solution performed on three occasions

Treatment:

Other: Glucose solution