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Evaluation of Carbohydrates - Glycemic Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508154
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
This study is an open-label with a randomized, cross-over design using standard GI methodology.

Condition or disease Intervention/treatment Phase
Glycemic Index Other: Control Meal 1 Other: Control Meal 2 Other: Experimental Nutritional Product Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Carbohydrates: Glycemic Index of Nutrition Product Formulation
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Blood glucose response curve [ Time Frame: 0 to 120 minutes ]
    area under the curve


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508154


Locations
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Canada, Ontario
Glycemic Index Laboratories Inc.
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Anne Dumas Abbott Nutrition
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03508154    
Other Study ID Numbers: DA19
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No