The Effect of a Carbohydrate Drink on Cognitive Function... | NCT02045342

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

NCT02045342

Sponsor

University of Western Ontario, Canada

Status

Unknown status

Last Update Posted

Jan 24, 2014Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Fatigue

Interventions

Carbohydrate drink
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 23, 2014

First Posted Date

Jan 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2014

Last Update Posted Date

Jan 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbohydrate drink	Experimental	Ingest 500ml (1g/kg) prior to metabolic measures.	Other: Carbohydrate drink Other: Placebo
Placebo	Placebo Comparator	Ingest 500ml of placebo prior to metabolic measures.	Other: Carbohydrate drink Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbohydrate drink	Other	Ingest 500ml (1g/kg) prior to metabolic measures.	Carbohydrate drink Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen Consumption		Four 10 minute measures throughout 90 min protocol (1 day).

Secondary Outcomes

Measure	Description	Time Frame
Appetite ratings		Four appetite ratings throughout 90 min protocol (1 day).
Cognitive function		2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Lemon, PhD	Contact	519 661 2111	88139	plemon@uwo.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Exercise Nutrition Research Laboratory, Western University		London	Ontario	N6A 3K7	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided