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

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.

Study Overview

• Status: Completed
• Conditions: Metabolism and Nutrition Disorders
• Intervention / Treatment: Other: High-SDS biscuit; Other: Low-SDS extruded cereals

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2006
    • Human Nutrition Unit, The 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 < 6.1 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-SDS biscuit; 50 g of moist biscuit with high-SDS content and low GI with a glass of water	Other: High-SDS biscuit; Consumption of the high-SDS product (50g) alone with a glass of water
Active Comparator: Low-SDS breakfast cereals; 42 g of extruded cereals with no SDS and medium to high GI with a glass of water	Other: Low-SDS extruded cereals; Consumption of the low-SDS product (42g) alone with a glass of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Response over 2 hours	iAUC of glycemia over 2 first hours of postprandial period	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood glucose kinetic	Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)	4 hours
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
Blood insulin kinetic	Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)	4 hours
Blood glucose peak	Maximal concentration and delta between maximum concentration and baseline value for glycemia	4 hours
Blood insulin peak	Maximal concentration and delta between maximum concentration and baseline value for insulinemia	4 hours

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: August 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 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 (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Nutrition, glycemic response, cereal products
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: KBE040