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

Not Applicable

Completed

• Conditions: Metabolic Disorder; Carbohydrate, Absorption, Intestine
• Interventions: Other: Sandwich biscuit high in SDS; Other: Co-extruded cereal low in SDS

• Registration Number: NCT02538653
• Lead Sponsor: Mondelēz International, Inc.

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sandwich biscuits high in SDS	Sandwich biscuit high in SDS	50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.
Co-extruded cereals low in SDS	Co-extruded cereal low in SDS	48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.

Primary Outcome Measures

Name	Time	Method
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products	2 hours after food consumption

Secondary Outcome Measures

Name	Time	Method
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 after food consumption
Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), over 3 hours (iAUC [0-180]), 4 hours (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 after food consumption

Trial Locations

Locations (1)

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia