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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Disorder; Carbohydrate, Absorption, Intestine
• Intervention / Treatment: Other: Sandwich biscuit high in SDS; Other: Co-extruded cereal low in SDS

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2006
      • University of Sydney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Sandwich biscuit high in SDS; Consumption of the high SDS product (50g) alone with a glass of water
Active Comparator: 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.	Other: Co-extruded cereal low in SDS; Consumption of the low SDS product (48.3 g) alone with a glass of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
The plasma glucose peak value and the time for this latter will also be calculated.	4 hours after food consumption
The plasma insulin peak value and the time for this latter will also be calculated.	4 hours after food consumption

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: University of Sydney
• Investigators: Principal Investigator: Jennie Brand Miller, University of Sydney

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: glycemic & insulin response, SDS, cereal product, Nutrition
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: KBE042