Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.

NCT ID: NCT02538640

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-10-31

Brief Summary

This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.

Detailed Description

This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.

Conditions

Metabolism and Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High-SDS biscuit

50 g of moist biscuit with high-SDS content and low GI with a glass of water

Group Type: EXPERIMENTAL

High-SDS biscuit

Intervention Type: OTHER

Consumption of the high-SDS product (50g) alone with a glass of water

Low-SDS breakfast cereals

42 g of extruded cereals with no SDS and medium to high GI with a glass of water

Group Type: ACTIVE_COMPARATOR

Low-SDS extruded cereals

Intervention Type: OTHER

Consumption of the low-SDS product (42g) alone with a glass of water

Interventions

High-SDS biscuit

Consumption of the high-SDS product (50g) alone with a glass of water

Intervention Type: OTHER

Low-SDS extruded cereals

Consumption of the low-SDS product (42g) alone with a glass of water

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged between 18-45 years.
• Non-smoker.
• BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
• Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
• Healthy subjects with:

• Normal glucose tolerance (fasting blood glucose < 6.0 mmol/L during the first test session and results of oral glucose tolerance test conducted within the last 30 days within recommendations (fasting blood glucose < 6.1 mmol/L, 120 minute glucose < 8.9 mmol/L))
• 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 tointerfere 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)
• Subject from the Australian Aboriginal ethnicity.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennie Brand Miller

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Human Nutrition Unit, The University of Sydney

Sydney, , Australia

Countries

Australia

Other Identifiers

KBE040

Identifier Type: -

Identifier Source: org_study_id