- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200845
The Role of Altered Nutrient Partitioning in Food Reward
Obesity remains a public health epidemic despite substantial advances in treatment strategies and therapies in the last decade. Effective strategies to support maintenance of improved metabolic health and reduced body weight are still needed.
Signals from the gut to the brain are important in regulating metabolism and energy balance and have been linked with food reward and preference in metabolically healthy individuals with normal body mass index. In particular, post-ingestive signaling related to glucose metabolism has been linked with food reward and preference. However, not much is known about how these gut and brain signals interact to influence eating behaviors in states of obesity or altered metabolic health. In addition, evidence in rodent models and human studies indicates obesity is associated with a blunted brain response to foods compared with normal body weight. However, whether altered nutrient utilization, termed metabolic inflexibility, influences the relationship between obesity and food reward has yet to be studied.
The overall objective of this proof-of-concept pilot study is to assess the feasibility of measuring reward response following a flavor-nutrient conditioning paradigm across the normal to obese body mass index (BMI) range and in states of altered metabolic health. The aims of this study are: 1) to determine whether differences in reinforcement learning/flavor-nutrient conditioning of carbohydrate can be measured across the body mass index range; and 2) to determine the feasibility of assessing metabolic flexibility and whether a relationship between metabolic flexibility and calorie-predictive reward can be detected.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose
- Other: Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose
- Other: High-Fat Test Meal Inside a Metabolic Chamber
- Other: High-Carbohydrate Test Meal Inside a Metabolic Chamber
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at Virginia Tech Carilion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI between 18.5-40 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
- Specific to fMRI scan only: BMI between 25-35 kg/m2
Exclusion Criteria:
- Current inhaled nicotine use
- History of alcohol dependence.
- Current or past diagnosis of diabetes or thyroid problems.
- Glycated hemoglobin (Hemoglobin A1C) >5.7%
- Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
- Active medical or neurologic disorder.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conditioned Stimulus+ (CS+) and High Fat Test Meal First
Participants will undergo exposure sessions with flavored beverage solutions containing sucrose first.
They will also undergo the high fat meal test session inside the metabolic chamber first.
Then, they will undergo exposure sessions with flavored beverages containing sucralose and the high carbohydrate test meal session.
|
Participants will consume flavored beverage solutions containing 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
A high-fat test meal (60% fat, 20% carbohydrate) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
A high-carbohydrate test meal (60% carbohydrate, 20% fat) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
|
Experimental: Conditioned Stimulus+ (CS+) and High Carbohydrate Test Meal First
Participants will undergo exposure sessions with flavored beverage solutions containing sucrose first.
They will also undergo the high carbohydrate meal test session inside the metabolic chamber first.
Then, they will undergo exposure sessions with flavored beverages containing sucralose and the high fat test meal session.
|
Participants will consume flavored beverage solutions containing 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
A high-fat test meal (60% fat, 20% carbohydrate) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
A high-carbohydrate test meal (60% carbohydrate, 20% fat) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
|
Experimental: Conditioned Stimulus- (CS-) and High Fat Test Meal First
Participants will undergo exposure sessions with flavored beverage solutions containing sucralose first.
They will also undergo the high fat meal test session inside the metabolic chamber first.
Then, they will undergo exposure sessions with flavored beverages containing sucrose and the high carbohydrate test meal session.
|
Participants will consume flavored beverage solutions containing 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
A high-fat test meal (60% fat, 20% carbohydrate) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
A high-carbohydrate test meal (60% carbohydrate, 20% fat) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
|
Experimental: Conditioned Stimulus- (CS-) and High Carbohydrate Test Meal First
Participants will undergo exposure sessions with flavored beverage solutions containing sucralose first.
They will also undergo the high carbohydrate meal test session inside the metabolic chamber first.
Then, they will undergo exposure sessions with flavored beverages containing sucrose and the high fat test meal session.
|
Participants will consume flavored beverage solutions containing 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
Participants will consume flavored beverage solutions sweetened with sucralose to match the sweetness of 75 calories of sucrose in 6 exposure sessions within 1 week.
One exposure session will include pre- and post-consumption blood draws over a 2-hour period, and one exposure session will include indirect calorimetry measurement pre- and post-consumption.
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.
A high-fat test meal (60% fat, 20% carbohydrate) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
A high-carbohydrate test meal (60% carbohydrate, 20% fat) will be provided after a 1-hour baseline measurement of substrate oxidation during a 6-hour metabolic chamber stay.
Postprandial substrate oxidation will be measured for 5 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference- liking
Time Frame: 15-minute measurement
|
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.
|
15-minute measurement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference- wanting
Time Frame: 15-minute measurement
|
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.
|
15-minute measurement
|
Change in preference- wanting
Time Frame: 30-minute measurement
|
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.
|
30-minute measurement
|
Change in preference- wanting
Time Frame: 5-minute measurement
|
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.
|
5-minute measurement
|
Blood oxygen level-dependent (BOLD) response to beverages
Time Frame: 30-minute measurement
|
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.
|
30-minute measurement
|
Substrate oxidation response to test meals
Time Frame: 6-hour measurement
|
Indirect calorimetry in a metabolic chamber will be used to assess substrate oxidation response to high-fat and high-carbohydrate test meals.
|
6-hour measurement
|
Blood glucose response to beverages
Time Frame: 2-hour measurement
|
Blood glucose will be assessed at baseline and at set time points for 2 hours after consumption of intervention beverages in one exposure session.
|
2-hour measurement
|
Blood insulin response to beverages
Time Frame: 2-hour measurement
|
Blood insulin will be assessed at baseline and at set time points for 2 hours after consumption of intervention beverages in an exposure session.
|
2-hour measurement
|
Energy expenditure in response to beverages
Time Frame: 1.5-hour measurement
|
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.
|
1.5-hour measurement
|
Respiratory exchange ratio in response to beverages
Time Frame: 1.5-hour measurement
|
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.
|
1.5-hour measurement
|
Substrate oxidation in response to beverages
Time Frame: 1.5-hour measurement
|
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.
|
1.5-hour measurement
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 21-964
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.
Clinical Trials on Overweight and Obesity
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
-
National Taiwan University HospitalCompleted
Clinical Trials on Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose
-
Virginia Polytechnic Institute and State UniversityRecruitingFood Preferences | Appetitive BehaviorUnited States