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

NCT02538640 | Completed

• 1 other identifier: KBE040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism and Nutrition Disorders

Keywords

Nutrition, glycemic response, cereal products

Outcome Measures

Primary Outcomes (1)

• Glycemic Response over 2 hours

  iAUC of glycemia over 2 first hours of postprandial period

  2 hours

Secondary Outcomes (6)

• Glycemic response

  4 hours

• Blood glucose kinetic

  4 hours

• Insulinemic response

  4 hours

• Blood insulin kinetic

  4 hours

• Blood glucose peak

  4 hours

Study Arms (2)

High-SDS biscuit

EXPERIMENTAL

50 g of moist biscuit with high-SDS content and low GI with a glass of water

Other: High-SDS biscuit

Low-SDS breakfast cereals

ACTIVE COMPARATOR

42 g of extruded cereals with no SDS and medium to high GI with a glass of water

Other: Low-SDS extruded cereals

Interventions

High-SDS biscuit OTHER

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

High-SDS biscuit

Low-SDS extruded cereals OTHER

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

Low-SDS breakfast cereals

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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 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.

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• University of Sydney: collaborator

Study Sites (1)

Human Nutrition Unit, The University of Sydney

Sydney, 2006, Australia

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Jennie Brand Miller

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

AU (1)