Different Glycemic Index (GI) Values in 7 Food Products

Glycemic Index Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278380
• Other study ID #: GDM.1.C/D
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: April 9, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is initiated to investigate the glycemic index value of seven food products.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glycemic Index

Intervention

Other:
• Low GI Standard Breakfast
Low GI Standard Breakfast
• Medium GI Standard Breakfast
Medium GI Standard Breakfast
• Enfamama A+
Nutritional pregnant milk supplement
• Glucerna Triple Care
Nutritional product for diabetics
• Dumex Precima
Pregnant and lactation women milk powder
• Diasip
Nutritional drinks for diabetics
• Test product
Test product not patented yet

Locations

Country	Name	City	State
Singapore	Temasek Polytechnic	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic index values of all seven products	Glycemic index values at 120 minutes post adminstration.	120 minutes post administration	No