NCT03508154

Brief Summary

This study is an open-label with a randomized, cross-over design using standard GI methodology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

15 days

First QC Date

April 16, 2018

Last Update Submit

May 25, 2018

Conditions

Glycemic Index

Outcome Measures

Primary Outcomes (1)

  • Blood glucose response curve

    area under the curve

    0 to 120 minutes

Study Arms (3)

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

Control Meal 1OTHER

carbohydrate test meal

Control Meal 1
Control Meal 2OTHER

carbohydrate test meal

Control Meal 2
Experimental Nutritional ProductOTHER

ready to drink nutritional formulation

Experimental Nutritional Product

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

Study Officials

  • Anne Dumas

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

May 7, 2018

Primary Completion

May 22, 2018

Study Completion

May 22, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

CA(1)