Clinical trial NCT02538640: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism and Nutrition Disorders
Keywords: Nutrition, glycemic response, cereal products
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Sydney
First posted: 2015-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Glycemic Response over 2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: Glycemic response
timeFrame: 4 hours
measure: Blood glucose kinetic
timeFrame: 4 hours
measure: Insulinemic response
timeFrame: 4 hours
measure: Blood insulin kinetic
timeFrame: 4 hours
measure: Blood glucose peak
timeFrame: 4 hours
measure: Blood insulin peak
timeFrame: 4 hours
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Human Nutrition Unit, The University of Sydney
Study officials:
affiliation: University of Sydney
name: Jennie Brand Miller
role: PRINCIPAL_INVESTIGATOR
References: