NCT02650674

Brief Summary

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

October 30, 2015

Last Update Submit

September 13, 2017

Conditions

Metabolic Disorder

Keywords

glycemic & insulin responseSDScereal productNutritionCarbohydrateAbsorptionIntestine

Outcome Measures

Primary Outcomes (1)

  • Glycaemic index values of five cereal products

    Determination of GI in both Caucasian and Asian subjects

    2 hours after food consumption

Secondary Outcomes (15)

  • Glycaemic response assessed by the glycemic index (GI) values of five cereal products

    2 hours after food consumption

  • Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products

    2 hours after food consumption

  • Glycaemic response assessed by the kinetic of glycemia over the 120 minutes

    2 hours after food consumption

  • Glycaemic response assessed by the peak value of glycemia

    2 hours after food consumption

  • Glycaemic response assessed by the delta value between baseline and peak values of glycemia

    2 hours after food consumption

  • +10 more secondary outcomes

Study Arms (6)

Product A: NP-0148

EXPERIMENTAL

Cereal product belVita Milk \& Cereals - High in SDS

Other: Product A: NP-0148

Product B: NP-0149

EXPERIMENTAL

Cereal product belVita Honey \& Nuts - High in SDS

Other: Product B: NP-0149

Product C: NP-0150

EXPERIMENTAL

Cereal product belVita Mixed Berry - High in SDS

Other: Product C: NP-0150

Product D: NP-0151

EXPERIMENTAL

Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat

Other: Product D: NP-0151

Product E: NP-0152

EXPERIMENTAL

Cereal product Kellogg's Trésor Duo Choco - Low in SDS

Other: Product E: NP-0152

Glucose reference

EXPERIMENTAL

Glucose solution performed on three occasions

Other: Glucose solution

Interventions

Product A: NP-0148OTHER

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product A: NP-0148
Glucose solutionOTHER

Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times

Glucose reference
Product B: NP-0149OTHER

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product B: NP-0149
Product C: NP-0150OTHER

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product C: NP-0150
Product D: NP-0151OTHER

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product D: NP-0151
Product E: NP-0152OTHER

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product E: NP-0152

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18-45 years.
  • Non-smoker.
  • BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
  • Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
  • Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
  • Healthy subjects with:
  • Normal glucose tolerance 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 to interfere with metabolism or dietary habits
  • Subject having given written consent to take part in the study.

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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

MeSH Terms

Conditions

Metabolic Diseases

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
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

January 8, 2016

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

AU(1)