- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07255183
Glucose and Motivation States
Impact of Blood Glucose on Motivation States: A Double-Blind Placebo-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marcus Kilpatrick, PhD
- Phone Number: 813-362-6696
- Email: mkilpatrick@usf.edu
Study Contact Backup
- Name: Andrea Barrows, MS
- Phone Number: 813-974-8127
- Email: andreabarrows@usf.edu
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33620
- Recruiting
- University of South Florida
-
Contact:
- Marcus Kilpatrick, PhD
- Phone Number: 813-362-6696
- Email: mkilpatrick@usf.edu
-
Contact:
- Andrea Barrows, MS
- Phone Number: 813-974-8127
- Email: andreabarrows@usf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index 18-30 m/kg^2
- Health Status: generally healthy; no cardiopulmonary/metabolic/orthopedic disease or limitations
- Blood Pressure: excluded with SBP of 130+ mmHg or DBP of 80+ mmHg
- Glucose Status: excluded and instructed to seek medical consultation if fasting values are <70 mg/dl or >125 mg/dl; included but encouraged to seek medical consultation if fasting values are 100-125 mg/dl
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise + sugar drink
|
Exercise 30 minutes at moderate intensity (10% below ventilatory threshold)
Consume 250mL beverage (water + 6 tablespoons table sugar)
|
|
Placebo Comparator: Exercise + non-sugar drink
|
Exercise 30 minutes at moderate intensity (10% below ventilatory threshold)
Consume 250mL beverage (water + 1.5 teaspoons of stevia powder)
|
|
Active Comparator: Rest + sugar drink
|
Consume 250mL beverage (water + 6 tablespoons table sugar)
|
|
Placebo Comparator: Rest + non-sugar drink
|
Consume 250mL beverage (water + 1.5 teaspoons of stevia powder)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Motivation to Move
Time Frame: 60 minutes
|
Score on movement subscale of Cravings for Rest and Volitional Energy Expenditure Survey (0 is lowest, 100 is highest)
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State motivation to rest
Time Frame: 60 minutes
|
Score on rest subscale of Cravings for Rest and Volitional Energy Expenditure Survey (0 is lowest, 100 is highest)
|
60 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY009043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual deidentified participant data (including data dictionaries) will be shared. This includes individual participant data that underlie the results reported in any aspect of a published article (text, tables, figures, and appendices).
Other documents that will be available include the study protocol, statistical analysis plan, informed consent form, and analytic code. The data will be available immediately after publication with no end date. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to Dr. Garrett Ash at Yale University (garrett.ash@yale.edu). To gain access, data requesters will need to sign a data access agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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