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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at Virginia Tech Carilion | Roanoke | Virginia | 24016 | United States |
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16 of 20 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria and 1 declined to participate.
20 individuals were screened for eligibility between February 1, 2022 and May 1, 2023 in Roanoke, VA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucrose first. Then, they underwent exposure sessions with flavored beverages containing sucralose. Participants underwent the high fat meal test session inside the metabolic chamber first. Then they underwent the high carbohydrate test meal session. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 |
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| 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. |
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| Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose | Other | 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. |
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| High-Fat Test Meal Inside a Metabolic Chamber | Other | 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. |
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| High-Carbohydrate Test Meal Inside a Metabolic Chamber | Other | 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. |
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| fMRI Scan | Other | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1.5-hour measurement |
| FG001 | Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucralose first. Then, they underwent exposure sessions with flavored beverages containing sucrose. Participants underwent the high fat meal test session inside the metabolic chamber first. Then they underwent the high carbohydrate test meal session. |
| FG002 | Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Carb Meal Then High Fat Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucralose first. Then, they underwent exposure sessions with flavored beverages containing sucrose. Participants underwent the high carbohydrate meal test session inside the metabolic chamber first. Then they underwent the high fat test meal session. |
| FG003 | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucrose first. Then, they underwent exposure sessions with flavored beverages containing sucralose. Participants underwent the high carbohydrate meal test session inside the metabolic chamber first. Then they underwent the high fat test meal session. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucrose first. Then, they underwent exposure sessions with flavored beverages containing sucralose. Participants underwent the high fat meal test session inside the metabolic chamber first. Then they underwent the high carbohydrate test meal session. |
| BG001 | Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucralose first. Then, they underwent exposure sessions with flavored beverages containing sucrose. Participants underwent the high fat meal test session inside the metabolic chamber first. Then they underwent the high carbohydrate test meal session. |
| BG002 | Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Carb Meal Then High Fat Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucralose first. Then, they underwent exposure sessions with flavored beverages containing sucrose. Participants underwent the high carbohydrate meal test session inside the metabolic chamber first. Then they underwent the high fat test meal session. |
| BG003 | Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal | Participants underwent exposure sessions with flavored beverage solutions containing sucrose first. Then, they underwent exposure sessions with flavored beverages containing sucralose. Participants underwent the high carbohydrate meal test session inside the metabolic chamber first. Then they underwent the high fat test meal session. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and at 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and at 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ml | 30-minute measurement |
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| Secondary | 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. | In the post-test session, participants are asked to choose between the CS+ and CS- beverage which they would like to take home in a forced choice test. | Posted | Count of Participants | Participants | 5-minute measurement |
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| Secondary | 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. | The sample size is smaller for this measure due to the feasibility assessment nature of the measure. Only a subset of our recruited participants were invited to complete this measure. Only individuals with BMI > 25 were recruited for this portion of the study. | Posted | Mean | Standard Deviation | arbitrary units | 30-minute measurement that occurs during the post-test, approximately 4 weeks after the first study session |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | fat oxidation grams/min*min | 6-hour measurement |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | mg/dl*min | 2-hour measurement |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | uIU/ml*min | 2-hour measurement |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | kcal/min*min | 1.5-hour measurement |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | ratio*minutes | 1.5-hour measurement |
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| Secondary | 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. | Smaller sample size due to missing data | Posted | Mean | Standard Deviation | carbohydrate oxidation grams/min*min | 1.5-hour measurement |
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7 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conditioned Stimulus+ (CS+) | Participants underwent exposure sessions with flavored beverage solutions containing sucrose. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Conditioned Stimulus- (CS-) | Participants underwent exposure sessions with flavored beverage solutions containing sucralose. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | High Fat Test Meal | Participants underwent the high fat meal test session inside a metabolic chamber. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | High Carbohydrate Test Meal | Participants underwent the high carbohydrate meal test session inside a metabolic chamber. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra DiFeliceantonio | Virginia Tech | 540-526-2285 | dife@vt.edu |
| Oct 10, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | Conditioned Stimulus - (CS-) | In a post-test, beverages (without calories) used during the intervention were 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 during functional magnetic resonance imaging (fMRI). Liquids delivered include the CS+ and CS- conditions (without calories) and a tasteless solution. Per our study protocol, the purpose of the fMRI scan is to assess feasibility, and only participants with BMI > 25 kg/m2 were asked to complete this portion of the protocol. Outcomes presented here are blood oxygen-level dependent (BOLD) response for contrasts of CS->tasteless solution deliveries. |
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