Clinical trial NCT02538653: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorder; Carbohydrate, Absorption, Intestine
Keywords: glycemic & insulin response, SDS, cereal product, Nutrition
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: TREATMENT

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.

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.

Primary outcomes:
measure: Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
timeFrame: 2 hours after food consumption
Secondary outcomes:
measure: 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.
timeFrame: 4 hours after food consumption
measure: 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.
timeFrame: 4 hours after food consumption
Other outcomes:
measure: The plasma glucose peak value and the time for this latter will also be calculated.
timeFrame: 4 hours after food consumption
measure: The plasma insulin peak value and the time for this latter will also be calculated.
timeFrame: 4 hours after food consumption
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Jennie Brand Miller
role: PRINCIPAL_INVESTIGATOR
References: