Evaluation of Carbohydrates - Glycemic Index | NCT03508154

Studies
Evaluation of Carbohydrates - Glycemic Index

NCT03508154

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Glycemic Index

Interventions

Control Meal 1
Control Meal 2
Experimental Nutritional Product

Countries

Canada

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

May 2018

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

May 7, 2018Actual

Primary Completion Date

May 22, 2018Actual

Completion Date

May 22, 2018Actual

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

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

May 25, 2018

Last Update Posted Date

May 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Meal 1	Active Comparator	Control carbohydrate solution	Other: Control Meal 1
Control Meal 2	Active Comparator	Control carbohydrate solution	Other: Control Meal 2
Experimental Nutritional Product	Experimental	Study nutritional formulation	Other: Experimental Nutritional Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control Meal 1	Other	carbohydrate test meal	Control Meal 1
Control Meal 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood glucose response curve	area under the curve	0 to 120 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects are males or non-pregnant females in good health
Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

Subjects with any type of food allergy or known history of AIDS, hepatitis, diabetes or a heart condition
Subjects taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Dumas	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glycemic Index Laboratories Inc.		Toronto	Ontario	M5C 2N8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided