Evaluation of Carbohydrates - Glycemic Index

Evaluation of Carbohydrates: Glycemic Index of Nutrition Product Formulation

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

Study Overview

• Status: Completed
• Conditions: Glycemic Index
• Intervention / Treatment: Other: Control Meal 1; Other: Control Meal 2; Other: Experimental Nutritional Product

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Meal 1; Control carbohydrate solution	Other: Control Meal 1; carbohydrate test meal
Active Comparator: Control Meal 2; Control carbohydrate solution	Other: Control Meal 2; carbohydrate test meal
Experimental: Experimental Nutritional Product; Study nutritional formulation	Other: Experimental Nutritional Product; ready to drink nutritional formulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Anne Dumas, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): May 22, 2018
• Study Completion (Actual): May 22, 2018

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: DA19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No