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

Primary Purpose

Metabolic Disorder; Carbohydrate, Absorption, Intestine

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sandwich biscuit high in SDS
Co-extruded cereal low in SDS
Sponsored by
Mondelēz International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Disorder; Carbohydrate, Absorption, Intestine focused on measuring glycemic & insulin response, SDS, cereal product, Nutrition

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Sydney

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sandwich biscuits high in SDS

Co-extruded cereals low in SDS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 31, 2015
Last Updated
September 13, 2017
Sponsor
Mondelēz International, Inc.
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02538653
Brief Title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
Official Title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mondelēz International, Inc.
Collaborators
University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disorder; Carbohydrate, Absorption, Intestine
Keywords
glycemic & insulin response, SDS, cereal product, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sandwich biscuits high in SDS
Arm Type
Experimental
Arm Description
50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.
Arm Title
Co-extruded cereals low in SDS
Arm Type
Active Comparator
Arm Description
48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.
Intervention Type
Other
Intervention Name(s)
Sandwich biscuit high in SDS
Intervention Description
Consumption of the high SDS product (50g) alone with a glass of water
Intervention Type
Other
Intervention Name(s)
Co-extruded cereal low in SDS
Intervention Description
Consumption of the low SDS product (48.3 g) alone with a glass of water
Primary Outcome Measure Information:
Title
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
Time Frame
2 hours after food consumption
Secondary Outcome Measure Information:
Title
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.
Time Frame
4 hours after food consumption
Title
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.
Time Frame
4 hours after food consumption
Other Pre-specified Outcome Measures:
Title
The plasma glucose peak value and the time for this latter will also be calculated.
Time Frame
4 hours after food consumption
Title
The plasma insulin peak value and the time for this latter will also be calculated.
Time Frame
4 hours after food consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie Brand Miller
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia

12. IPD Sharing Statement

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

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