Overweight and ObesityNCT05200845
The Role of Altered Nutrient Partitioning in Food Reward
A study testing Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose, Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose and High-Fat Test Meal Inside a Metabolic Chamber in people with Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose, Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose and High-Fat Test Meal Inside a Metabolic Chamber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at Virginia Tech Carilion
Roanoke, Virginia, 24016
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose, Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose, High-Fat Test Meal Inside a Metabolic Chamber, High-Carbohydrate Test Meal Inside a Metabolic Chamber, fMRI Scan
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucroseOther
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.
Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucraloseOther
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.
High-Fat Test Meal Inside a Metabolic ChamberOther
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.
High-Carbohydrate Test Meal Inside a Metabolic ChamberOther
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.
fMRI ScanOther
A subset of participants with BMI > 25 will be invited to complete an functional magnetic resonance imaging (fMRI) scan as a feasibility measure. 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. Because this is feasibility-based measure, the outcome is a count of participants who completed this task.
| Study group | Role | What they receive |
|---|---|---|
| Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal | Experimental | Participants will undergo exposure sessions with flavored beverage solutions containing sucrose first. Then, they will undergo exposure sessions with flavored beverages containing sucralose. Participants will undergo the high fat meal test session inside the metabolic chamber first. Then they will undergo the high carbohydrate test meal session. Receives: 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; Other: fMRI Scan |
| Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal | Experimental | Participants will undergo exposure sessions with flavored beverage solutions containing sucralose first. Then, they will undergo exposure sessions with flavored beverages containing sucrose. Participants will undergo the high fat meal test session inside the metabolic chamber first. Then they will undergo the high carbohydrate test meal session. Receives: 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; Other: fMRI Scan |
| Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal | Experimental | Participants will undergo exposure sessions with flavored beverage solutions containing sucralose first. Then, they will undergo exposure sessions with flavored beverages containing sucrose. Participants will undergo the high carbohydrate meal test session inside the metabolic chamber first. Then they will undergo the high fat test meal session. Receives: 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; Other: fMRI Scan |
| Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal | Experimental | Participants will undergo exposure sessions with flavored beverage solutions containing sucrose first. Then, they will undergo exposure sessions with flavored beverages containing sucralose. Participants will undergo the high carbohydrate meal test session inside the metabolic chamber first. Then they will undergo the high fat test meal session. Receives: 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; Other: fMRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preference- Liking
Subjective ratings of liking of flavors used in the intervention were 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.
Measured: Baseline and at 4 weeks
Secondary outcomes (10)
Post-test Preference - Wanting
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.
Measured: Baseline and at 4 weeks
Change in Preference- Wanting
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. Total beverage intake over 30 minutes is reported as the outcome.
Measured: 30-minute measurement
Change in Preference- Wanting
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. The outcome variable is a count of number of participants who chose each beverage condition during the forced choice test.
Measured: 5-minute measurement
Blood Oxygen Level-dependent (BOLD) Response to Beverages
In a post-test session, functional magnetic resonance imaging (fMRI) scans were performed while beverages (without calories) used during the intervention and a tasteless solution 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. Only participants with BMI > 25 were invited to complete this portion of the study, per our protocol. In total, participants receive the CS+, CS-, and tasteless (control) solutions 24 times over the course of 2 runs. Contrasts of interest are the blood oxygen level-dependent (BOLD) response of CS+>tasteless solution and CS->tasteless solution deliveries. Parameter estimates for these contrasts are extracted and reported. A positive outcome reflects greater whole-brain BOLD response for the CS condition compared with a tasteless solution.
Measured: 30-minute measurement that occurs during the post-test, approximately 4 weeks after the first study session
Substrate Oxidation Response to Test Meals
Indirect calorimetry in a metabolic chamber will be used to assess substrate oxidation response to high-fat and high-carbohydrate test meals.
Measured: 6-hour measurement
Blood Glucose Response to Beverages
Blood glucose will be assessed at baseline and at set time points for 1 hour after consumption of intervention beverages in one exposure session.
Measured: 2-hour measurement
Blood Insulin Response to Beverages
Blood insulin will be assessed at baseline and at set time points for 2 hours after consumption of intervention beverages in an exposure session.
Measured: 2-hour measurement
Energy Expenditure in Response to Beverages
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.
Measured: 1.5-hour measurement
Respiratory Exchange Ratio in Response to Beverages
Indirect calorimetry will be used to determine respiratory exchange ratio (RER) at baseline (for 30 minutes) and for 1 hour after consumption of intervention beverages in an exposure session. Areas under the curve for change in RER were calculated for each condition and presented as outcomes.
Measured: 1.5-hour measurement
Substrate Oxidation in Response to Beverages
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.
Measured: 1.5-hour measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start23 Feb 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Alexandra DiFeliceantonio, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200845
- Sponsor's protocol ID
- 21-964
- Status last verified
- Aug 2025
- First submitted
- 17 Dec 2021
- Last updated
- 8 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Altered Nutrient Partitioning in Food Reward
- ClinicalTrials.gov ID
- NCT05200845
- Acronym / sponsor ID
- 21-964
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal | Experimental | 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, Other: fMRI ScanParticipants will undergo exposure sessions with flavored beverage solutions containing sucrose first. Then, they will undergo exposure sessions with flavored beverages containing sucralose. Participants will undergo the high fat meal test session inside the metabolic chamber first. Then they will undergo the high carbohydrate test meal session. |
| Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal | Experimental | 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, Other: fMRI ScanParticipants will undergo exposure sessions with flavored beverage solutions containing sucralose first. Then, they will undergo exposure sessions with flavored beverages containing sucrose. Participants will undergo the high fat meal test session inside the metabolic chamber first. Then they will undergo the high carbohydrate test meal session. |
| Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal | Experimental | 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, Other: fMRI ScanParticipants will undergo exposure sessions with flavored beverage solutions containing sucralose first. Then, they will undergo exposure sessions with flavored beverages containing sucrose. Participants will undergo the high carbohydrate meal test session inside the metabolic chamber first. Then they will undergo the high fat test meal session. |
| Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal | Experimental | 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, Other: fMRI ScanParticipants will undergo exposure sessions with flavored beverage solutions containing sucrose first. Then, they will undergo exposure sessions with flavored beverages containing sucralose. Participants will undergo the high carbohydrate meal test session inside the metabolic chamber first. Then they will undergo the high fat test meal session. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucroseParticipants 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. | Other | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal, Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal |
| Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucraloseParticipants 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. | Other | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal, Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal |
| High-Fat Test Meal Inside a Metabolic ChamberA 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. | Other | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal, Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal |
| High-Carbohydrate Test Meal Inside a Metabolic ChamberA 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. | Other | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal, Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal |
| fMRI ScanA subset of participants with BMI > 25 will be invited to complete an functional magnetic resonance imaging (fMRI) scan as a feasibility measure. 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. Because this is feasibility-based measure, the outcome is a count of participants who completed this task. | Other | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal, Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal, Conditioned Stimulus- (CS-)Then Conditioned Stimulus+ (CS+) and High Carb Meal Then High Fat Meal |
Primary outcome
Change in Preference- Liking
Time frame: Baseline and at 4 weeks
Subjective ratings of liking of flavors used in the intervention were 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.
10 secondary outcomes
Post-test Preference - Wanting
Time frame: Baseline and at 4 weeks
Change in Preference- Wanting
Time frame: 30-minute measurement
Change in Preference- Wanting
Time frame: 5-minute measurement
Blood Oxygen Level-dependent (BOLD) Response to Beverages
Time frame: 30-minute measurement that occurs during the post-test, approximately 4 weeks after the first study session
Substrate Oxidation Response to Test Meals
Time frame: 6-hour measurement
Blood Glucose Response to Beverages
Time frame: 2-hour measurement
Blood Insulin Response to Beverages
Time frame: 2-hour measurement
Energy Expenditure in Response to Beverages
Time frame: 1.5-hour measurement
Respiratory Exchange Ratio in Response to Beverages
Time frame: 1.5-hour measurement
Substrate Oxidation in Response to Beverages
Time frame: 1.5-hour measurement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose, Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose and High-Fat Test Meal Inside a Metabolic Chamber in people with Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Preference- Liking (time frame: Baseline and at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.