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

NCT ID: NCT02538653

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

Brief Summary

This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.

Detailed Description

This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content. It is a laboratory-based research study with an open cross-over design, including 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 2 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list.

Conditions

Metabolic Disorder; Carbohydrate, Absorption, Intestine

Study Design

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

Study Groups

Sandwich biscuits high in SDS

50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.

Group Type: EXPERIMENTAL

Sandwich biscuit high in SDS

Intervention Type: OTHER

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

Co-extruded cereals low in SDS

48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.

Group Type: ACTIVE_COMPARATOR

Co-extruded cereal low in SDS

Intervention Type: OTHER

Consumption of the low SDS product (48.3 g) alone with a glass of water

Interventions

Sandwich biscuit high in SDS

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

Intervention Type: OTHER

Co-extruded cereal low in SDS

Consumption of the low SDS product (48.3 g) 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 < 6.0 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

University of Sydney

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

KBE042

Identifier Type: -

Identifier Source: org_study_id