Different Glycemic Index (GI) Values in 7 Food Products | NCT02278380

Studies
Different Glycemic Index (GI) Values in 7 Food Products

NCT02278380

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Glycemic Index

Interventions

Low GI Standard Breakfast
Medium GI Standard Breakfast
Enfamama A+
Glucerna Triple Care
Dumex Precima
Diasip
Test product

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Oct 27, 2014

First Posted Date

Oct 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Other	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	Other: Low GI Standard Breakfast Other: Medium GI Standard Breakfast Other: Enfamama A+ Other: Glucerna Triple Care Other: Dumex Precima Other: Diasip Other: Test product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low GI Standard Breakfast	Other	Low GI Standard Breakfast	Arm 1
Medium GI Standard Breakfast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic index values of all seven products	Glycemic index values at 120 minutes post adminstration.	120 minutes post administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided