The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
Primary Purpose
Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carbohydrate drink
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
Eligibility Criteria
Inclusion Criteria:
- healthy, 18 to 35 year old man or woman.
Exclusion Criteria:
- smoker
- pregnancy
- taking part in other research.
- followed a weight loss diet in the previous 6 months.
- history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
- neurological or psychiatric condition that may cause cognitive dysfunction.
Sites / Locations
- Exercise Nutrition Research Laboratory, Western University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Carbohydrate drink
Placebo
Arm Description
Ingest 500ml (1g/kg) prior to metabolic measures.
Ingest 500ml of placebo prior to metabolic measures.
Outcomes
Primary Outcome Measures
Oxygen Consumption
Secondary Outcome Measures
Appetite ratings
Cognitive function
Full Information
NCT ID
NCT02045342
First Posted
January 22, 2014
Last Updated
January 23, 2014
Sponsor
University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02045342
Brief Title
The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
Official Title
The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate drink
Arm Type
Experimental
Arm Description
Ingest 500ml (1g/kg) prior to metabolic measures.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ingest 500ml of placebo prior to metabolic measures.
Intervention Type
Other
Intervention Name(s)
Carbohydrate drink
Intervention Description
Ingest 500ml (1g/kg) prior to metabolic measures.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Ingest 500ml of placebo prior to metabolic measures.
Primary Outcome Measure Information:
Title
Oxygen Consumption
Time Frame
Four 10 minute measures throughout 90 min protocol (1 day).
Secondary Outcome Measure Information:
Title
Appetite ratings
Time Frame
Four appetite ratings throughout 90 min protocol (1 day).
Title
Cognitive function
Time Frame
2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy, 18 to 35 year old man or woman.
Exclusion Criteria:
smoker
pregnancy
taking part in other research.
followed a weight loss diet in the previous 6 months.
history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
neurological or psychiatric condition that may cause cognitive dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Lemon, PhD
Phone
519 661 2111
Ext
88139
Email
plemon@uwo.ca
Facility Information:
Facility Name
Exercise Nutrition Research Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
Phone
519 661 2111
Ext
88139
Email
plemon@uwo.ca
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
12. IPD Sharing Statement
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The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
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