- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053294
Neural and Metabolic Factors in Carbohydrate Reward (CARB)
Neural and Metabolic Factors in Carbohydrate Reward: An Examination of Speed
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra G DiFeliceantonio, PhD
- Phone Number: 5405262285
- Email: dife@vt.edu
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Fralin Biomedical Research Institute at VTC
-
Contact:
- Alexandra G DiFeliceantonio, PhD
- Phone Number: 540-526-2285
- Email: dife@vt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI between 18.5-30 kg/m2
- Not pregnant or planning to become pregnant during study participation
- Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
- Able to speak and write in English
Exclusion Criteria:
- Current inhaled nicotine use
- History of alcohol dependence.
- Current or past diagnosis of diabetes or thyroid problems.
- Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
- Active medical or neurologic disorder.
- Current shift work (typical pattern of work/activity overnight)
- Previous weight loss surgery
- Adherence to a special diet within the past 3 months (e.g., low-carb or ketogenic diet, exclusion of food groups/specific macronutrients, intermittent fasting, etc.)
- Allergy to any food or ingredient included in the study diets, meals, or beverages
- Currently pregnant or planning to become pregnant during study participation
- Claustrophobia
- Contraindications for MRI, including pacemaker, aneurysm clips, neurostimulators, cochlear or other implants, metal in eyes, regular work with steel, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CS- First
Participants who receive the conditional stimulus (CS) - first.
|
Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of sucrose.
Participants will consume flavored beverage solutions containing 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of maltodextrin.
Participants will consume flavored beverage solutions containing 110 calories of maltodexrin in 6 exposure sessions within 1 week.One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
|
Experimental: CS+Fast First
Participants who receive the CS+Fast First
|
Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of sucrose.
Participants will consume flavored beverage solutions containing 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of maltodextrin.
Participants will consume flavored beverage solutions containing 110 calories of maltodexrin in 6 exposure sessions within 1 week.One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
|
Experimental: CS+Slow First
Participants who receive the CS+Slow First
|
Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of sucrose.
Participants will consume flavored beverage solutions containing 110 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
(CS+): Flavored beverage solution with 110 calories of maltodextrin.
Participants will consume flavored beverage solutions containing 110 calories of maltodexrin in 6 exposure sessions within 1 week.One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurement over a 2-hour period.
The other 4 exposure sessions will occur at specified times outside the laboratory sessions.
Subjective ratings of internal state (i.e., hunger, fullness, and thirst) will be collected throughout each exposure.
Subjective ratings of liking and wanting of each beverage will also be assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference- liking
Time Frame: at the end of the study; 5 weeks after start of study
|
Subjective ratings of liking of flavors used in the intervention will be assessed at baseline and after the intervention. The generalized Labeled Magnitude Scale will be used. The scale is anchored by descriptors of "Most Disliked Sensation Imaginable" and "Most Liked Sensation Imaginable" at the lower and upper ends, respectively. The score is determined by the place on the scale participants select (range of scale is 0-100). An increase in score from baseline to post-intervention indicates an increase in liking. |
at the end of the study; 5 weeks after start of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference- wanting, ad lib intake
Time Frame: at the end of the study; 5 weeks after start of study
|
Ad libitum intake will be used as a measure of wanting in a post-test session.
Participants will be provided each beverage used during the intervention and asked to drink as much or as little of them as they would like over a 30- minute period.
|
at the end of the study; 5 weeks after start of study
|
Change in preference- wanting, forced choice
Time Frame: at the end of the study; 5 weeks after start of study
|
Forced choice will be used as a measure of wanting in a post-test session.
Participants will be provided each of the beverages used during the intervention and asked to choose 1 to take home with them.
|
at the end of the study; 5 weeks after start of study
|
Blood oxygen level-dependent (BOLD) response to beverages
Time Frame: at the end of the study; 5 weeks after start of study
|
In a post-test session, functional magnetic resonance imaging (fMRI) scans will be performed while beverages (without calories) used during the intervention are delivered through a custom manifold fitted to a head coil and connected to a pump system that allows precisely timed and measured delivery of liquids.
|
at the end of the study; 5 weeks after start of study
|
Blood glucose response to beverages
Time Frame: Each week for 3 weeks during the study
|
Blood glucose will be assessed at baseline and at set time points for 1 hour after consumption of intervention beverages in one exposure session.
|
Each week for 3 weeks during the study
|
Blood insulin response to beverages
Time Frame: Each week for 3 weeks during the study
|
Blood insulin will be assessed at baseline and at set time points for 2 hours after consumption of intervention beverages in an exposure session.
|
Each week for 3 weeks during the study
|
Energy expenditure in response to beverages
Time Frame: Each week for 3 weeks during the study
|
Indirect calorimetry will be used to determine energy expenditure at baseline (for 30 minutes) and for 1 hour after consumption of intervention beverages in an exposure session.
|
Each week for 3 weeks during the study
|
Respiratory exchange ratio in response to beverages
Time Frame: Each week for 3 weeks during the study
|
Indirect calorimetry will be used to determine respiratory exchange ratio at baseline (for 30 minutes) and for 1 hour after consumption of intervention beverages in an exposure session.
|
Each week for 3 weeks during the study
|
Substrate oxidation in response to beverages
Time Frame: Each week for 3 weeks during the study
|
Indirect calorimetry will be used to determine substrate oxidation at baseline (for 30 minutes) and for 1 hour after consumption of intervention beverages in an exposure session.
|
Each week for 3 weeks during the study
|
Change in preference- wanting, rated
Time Frame: at the end of the study; 5 weeks after start of study
|
Subjective ratings of wanting of flavors used in the intervention will be assessed at baseline and after the intervention.
A Visual Analog Scale will be used.
Participants select a place on the line that corresponds with their subjective rating, and the score is determined by the place selected (range of scores is 0-100).
The line is anchored by polar opposite descriptors ("Do not want at all" and "Want very much").
An increase in score from baseline to post-intervention indicates and increase in wanting.
|
at the end of the study; 5 weeks after start of study
|
Collaborators and Investigators
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
Other Study ID Numbers
- 19-927
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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