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Completed

NCT Number: NCT02538640

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Unit, The University of Sydney

Sydney, 2006, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-SDS biscuit

Other

Consumption of the high-SDS product (50g) alone with a glass of water

Low-SDS extruded cereals

Other

Consumption of the low-SDS product (42g) alone with a glass of water

Primary outcomes

  1. Glycemic Response over 2 hours

    Time frame: 2 hours

    iAUC of glycemia over 2 first hours of postprandial period

Secondary outcomes

  1. Glycemic response

    Time frame: 4 hours

    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

  2. Blood glucose kinetic

    Time frame: 4 hours

    Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)

  3. Insulinemic response

    Time frame: 4 hours

    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. Blood insulin kinetic

    Time frame: 4 hours

    Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)

  5. Blood glucose peak

    Time frame: 4 hours

    Maximal concentration and delta between maximum concentration and baseline value for glycemia

  6. Blood insulin peak

    Time frame: 4 hours

    Maximal concentration and delta between maximum concentration and baseline value for insulinemia

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • University of Sydney

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2015
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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