- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015490
The Impact of the Physiological Response to Sugar on Brain Activity and Behavior
The goal of this pilot study is to test the feasibility of assessing how biological factors and chemical properties of sugars may influence metabolism and food reward in humans. The main questions it aims to answer are:
- Can differences in appetitive responses and neural activations to sucrose (table sugar) and its chemical components (glucose and fructose) be measured and quantified?
- Are there detectable differences in how combinations of sugars and non-nutritive sweeteners commonly found in our food supply influence appetitive responses and neural activation?
This study is a crossover design, meaning every participant will complete every condition. Participants will consume beverages containing sucrose, glucose, or fructose, which are each novelly flavored, 6 times within a week. During one of the consumption times, energy expenditure, carbohydrate oxidation, and blood glucose will be measured in the lab before and for 2 hours after consumption. After participants have consumed each condition, they will undergo a tasting task in the MRI scanner, neural responses to receipt of the beverages are measured. Another group of participants will undergo the same study design but with sucrose, high fructose corn syrup, or sucrose + non-nutritive sweetener as the conditions.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Conditioned Stimulus: Sucrose (aim 1)
- Other: Conditioned Stimulus: Glucose (aim 1)
- Other: Conditioned Stimulus: Fructose (aim 1)
- Other: Conditioned Stimulus: Sucrose (aim 2)
- Other: Conditioned Stimulus: High Fructose Corn Syrup (aim 2)
- Other: Conditioned Stimulus: Sucrose + Non-nutritive Sweetener (aim 2)
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra DiFeliceantonio, PhD
- Phone Number: 540-526-2285
- Email: dife@vtc.vt.edu
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Fralin Biomedical Research Institute at Virginia Tech Carilion
-
Contact:
- Alexandra DiFeliceantonio, PhD
- Phone Number: 540-526-2285
- Email: dife@vtc.vt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI between 18.5-25 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 (FBRI) at Virginia Tech Carilion
- Weigh at least 110 lbs
Exclusion Criteria:
- Current inhaled nicotine use
- History of alcohol dependence.
- Current or past diagnosis of cardiometabolic disease or problems, including diabetes, endocrine, heart, or thyroid problems, that may influence study outcomes
- Hemoglobin A1C >5.7%
- Taking medications known to influence study measures (including attention-deficit/hyperactivity disorder (ADHD), allergy, antidepressant, antipsychotic, anxiolytic, birth control, blood pressure, blood glucose, cholesterol, thyroid, sleep, or weight loss medications)
- Active medical or neurologic disorder, including cardiometabolic conditions or gastrointestinal conditions that may influence study outcomes
- Recent change in body weight (gain or loss of > 5 lbs within the past 3 months)
- 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. (Note: This is an fMRI-specific exclusion criterion. Participants may be allowed to participate in all other study sessions and measures that do not involve fMRI.)
- Contraindications for bioelectrical impedance analysis, specifically implanted devices
- Use of substances (or combinations of substances) in doses and frequencies that could influence neural outcomes of study.
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: Conditioned Stimulus: Sucrose (aim 1)
Participants will undergo exposure sessions with flavored beverage solutions containing 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 measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
Experimental: Conditioned Stimulus: Glucose (aim 1)
Participants will undergo exposure sessions with flavored beverage solutions containing glucose.
|
Participants will consume flavored beverage solutions containing 110 calories of glucose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
Experimental: Conditioned Stimulus: Fructose (aim 1)
Participants will undergo exposure sessions with flavored beverage solutions containing fructose.
|
Participants will consume flavored beverage solutions containing 110 calories of fructose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
Experimental: Conditioned Stimulus: Sucrose (aim 2)
Participants will undergo exposure sessions with flavored beverage solutions containing 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 measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
Experimental: Conditioned Stimulus: High Fructose Corn Syrup (aim 2)
Participants will undergo exposure sessions with flavored beverage solutions containing high fructose corn syrup.
|
Participants will consume flavored beverage solutions containing 110 calories of high fructose corn syrup in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
Experimental: Conditioned Stimulus: Sucrose + Non-nutritive Sweetener (aim 2)
Participants will undergo exposure sessions with flavored beverage solutions containing sucrose and a non-nutritive sweetener.
|
Participants will consume flavored beverage solutions containing a non-nutritive sweetener and 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 measurements inside a metabolic chamber over a 2-hour period.
The other 5 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference- liking
Time Frame: Immediately after informed consent and in the post-test session approximately 5 weeks later
|
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.
|
Immediately after informed consent and in the post-test session approximately 5 weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Test Measure of Preference- wanting
Time Frame: At the end of study; approximately 5 weeks after first session
|
Subjective ratings of liking 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 study; approximately 5 weeks after first session
|
Post-Test Measure of Preference - wanting (ad libitum)
Time Frame: At the end of study; approximately 5 weeks after first session
|
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 study; approximately 5 weeks after first session
|
Post-Test Measure of Preference- wanting (forced choice)
Time Frame: At the end of study; approximately 5 weeks after first session
|
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 study; approximately 5 weeks after first session
|
Blood oxygen level-dependent (BOLD) response to beverages
Time Frame: At the end of study; approximately 5 weeks after first session
|
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 study; approximately 5 weeks after first session
|
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 2 hours after consumption of intervention beverages in one 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 and after consumption of intervention beverages in an exposure session.
|
Each week for 3 weeks during the 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- #23-297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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