The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance

Fatigue Clinical Trial

Official title:

The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02045342
• Other study ID #: 104111
• Status: Not yet recruiting
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 23, 2014
• Start date: January 2014

Study information

• Verified date: January 2014
• Source: University of Western Ontario, Canada
• Contact: Peter Lemon, PhD
• Phone: 519 661 2111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Carbohydrate drink
Ingest 500ml (1g/kg) prior to metabolic measures.
• Placebo
Ingest 500ml of placebo prior to metabolic measures.

Locations

Country	Name	City	State
Canada	Exercise Nutrition Research Laboratory, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption		Four 10 minute measures throughout 90 min protocol (1 day).	No
Secondary	Appetite ratings		Four appetite ratings throughout 90 min protocol (1 day).	No
Secondary	Cognitive function		2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).	No