Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Primary Purpose
Metabolism and Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
High-SDS biscuit
Low-SDS extruded cereals
Sponsored by
About this trial
This is an interventional prevention trial for Metabolism and Nutrition Disorders focused on measuring Nutrition, glycemic response, cereal products
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 < 6.1 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.
Sites / Locations
- Human Nutrition Unit, The University of Sydney
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-SDS biscuit
Low-SDS breakfast cereals
Arm Description
50 g of moist biscuit with high-SDS content and low GI with a glass of water
42 g of extruded cereals with no SDS and medium to high GI with a glass of water
Outcomes
Primary Outcome Measures
Glycemic Response over 2 hours
iAUC of glycemia over 2 first hours of postprandial period
Secondary Outcome Measures
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
Blood glucose kinetic
Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)
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.
Blood insulin kinetic
Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)
Blood glucose peak
Maximal concentration and delta between maximum concentration and baseline value for glycemia
Blood insulin peak
Maximal concentration and delta between maximum concentration and baseline value for insulinemia
Full Information
NCT ID
NCT02538640
First Posted
August 31, 2015
Last Updated
October 30, 2015
Sponsor
Mondelēz International, Inc.
Collaborators
University of Sydney
1. Study Identification
Unique Protocol Identification Number
NCT02538640
Brief Title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Official Title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorders
Keywords
Nutrition, glycemic response, cereal products
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-SDS biscuit
Arm Type
Experimental
Arm Description
50 g of moist biscuit with high-SDS content and low GI with a glass of water
Arm Title
Low-SDS breakfast cereals
Arm Type
Active Comparator
Arm Description
42 g of extruded cereals with no SDS and medium to high GI with a glass of water
Intervention Type
Other
Intervention Name(s)
High-SDS biscuit
Intervention Description
Consumption of the high-SDS product (50g) alone with a glass of water
Intervention Type
Other
Intervention Name(s)
Low-SDS extruded cereals
Intervention Description
Consumption of the low-SDS product (42g) alone with a glass of water
Primary Outcome Measure Information:
Title
Glycemic Response over 2 hours
Description
iAUC of glycemia over 2 first hours of postprandial period
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Glycemic response
Description
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
Title
Blood glucose kinetic
Description
Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)
Time Frame
4 hours
Title
Insulinemic response
Description
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.
Time Frame
4 hours
Title
Blood insulin kinetic
Description
Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)
Time Frame
4 hours
Title
Blood glucose peak
Description
Maximal concentration and delta between maximum concentration and baseline value for glycemia
Time Frame
4 hours
Title
Blood insulin peak
Description
Maximal concentration and delta between maximum concentration and baseline value for insulinemia
Time Frame
4 hours
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 < 6.1 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.
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
Human Nutrition Unit, The University of Sydney
City
Sydney
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 and GI Consumed Alone.
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