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

Metabolism and Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538640
• Other study ID #: KBE040
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: October 30, 2015
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorders
• Nutrition Disorders

Intervention

Other:
• High-SDS biscuit
Consumption of the high-SDS product (50g) alone with a glass of water
• Low-SDS extruded cereals
Consumption of the low-SDS product (42g) alone with a glass of water

Locations

Country	Name	City	State
Australia	Human Nutrition Unit, The University of Sydney	Sydney

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Response over 2 hours	iAUC of glycemia over 2 first hours of postprandial period	2 hours	No
Secondary	Glycemic response	Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed	4 hours	No
Secondary	Blood glucose kinetic	Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)	4 hours	No
Secondary	Insulinemic response	Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.	4 hours	No
Secondary	Blood insulin kinetic	Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)	4 hours	No
Secondary	Blood glucose peak	Maximal concentration and delta between maximum concentration and baseline value for glycemia	4 hours	No
Secondary	Blood insulin peak	Maximal concentration and delta between maximum concentration and baseline value for insulinemia	4 hours	No