- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045342
The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
January 23, 2014 updated by: University of Western Ontario, Canada
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Exercise Nutrition Research Laboratory, Western University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbohydrate drink
Ingest 500ml (1g/kg) prior to metabolic measures.
|
Ingest 500ml (1g/kg) prior to metabolic measures.
Ingest 500ml of placebo prior to metabolic measures.
|
|
Placebo Comparator: Placebo
Ingest 500ml of placebo prior to metabolic measures.
|
Ingest 500ml (1g/kg) prior to metabolic measures.
Ingest 500ml of placebo prior to metabolic measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oxygen Consumption
Time Frame: Four 10 minute measures throughout 90 min protocol (1 day).
|
Four 10 minute measures throughout 90 min protocol (1 day).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Appetite ratings
Time Frame: Four appetite ratings throughout 90 min protocol (1 day).
|
Four appetite ratings throughout 90 min protocol (1 day).
|
|
Cognitive function
Time Frame: 2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
|
2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
January 22, 2014
First Submitted That Met QC Criteria
January 23, 2014
First Posted (Estimate)
January 24, 2014
Study Record Updates
Last Update Posted (Estimate)
January 24, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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