- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278380
Different Glycemic Index (GI) Values in 7 Food Products
April 9, 2015 updated by: Danone Asia Pacific Holdings Pte, Ltd.
In-Vivo Glycemic Index (GI) and Insulinemic Index (II) Testing of 7 Test Foods in Total (5 Milk-based Beverage and 2 Standard Breakfast Items)
This study is initiated to investigate the glycemic index value of seven food products.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore
- Temasek Polytechnic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males or non-pregnant females at least 6 weeks postpartum, non-lactating and aged 21-60yrs old in both groups.
- They should not suffer from any chronic diseases.
- no known food allergy or intolerance.
- no medications known to affect glucose tolerance(excluding oral contraceptives). Note: stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
Exclusion Criteria:
- Age less than 21 years old and greater than 60 years old.
- known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- known history of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
- subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.,
- subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion and have no known food allergies.
- a major medical or surgical event requiring hospitalisation within the preceding 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
To compare the Glycemic Index value of seven test foods: Low GI standard Breakfast Medium GI standard Breakfast Nutritional pregnant milk supplement Nutritional product for diabetics Pregnant and lactation women milk powder Nutritional drinks for diabetics Test product |
Low GI Standard Breakfast
Medium GI Standard Breakfast
Nutritional pregnant milk supplement
Nutritional product for diabetics
Pregnant and lactation women milk powder
Nutritional drinks for diabetics
Test product not patented yet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic index values of all seven products
Time Frame: 120 minutes post administration
|
Glycemic index values at 120 minutes post adminstration.
|
120 minutes post administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kalpana Bhaskaran, Dr, Temasek Polytechnic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
September 12, 2014
First Submitted That Met QC Criteria
October 27, 2014
First Posted (Estimate)
October 30, 2014
Study Record Updates
Last Update Posted (Estimate)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- GDM.1.C/D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.