Trial Outcomes & Findings for The Role of Altered Nutrient Partitioning in Food Reward (NCT NCT05200845)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and at 4 weeks

Results posted on

2025-09-08

Participant Flow

20 individuals were screened for eligibility between February 1, 2022 and May 1, 2023 in Roanoke, VA.

16 of 20 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria and 1 declined to participate.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	3	5	5	3
Overall Study COMPLETED	2	3	2	3
Overall Study NOT COMPLETED	1	2	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study stopped collecting pilot data for metabolic chamber	1	1	2	0
Overall Study Withdrawal by Subject	0	1	1	0

Baseline Characteristics

The Role of Altered Nutrient Partitioning in Food Reward

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Fat Meal Then High Carb Meal n=3 Participants 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.	Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Fat Meal Then High Carb Meal n=5 Participants 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.	Conditioned Stimulus- (CS-) Then Conditioned Stimulus+ (CS+), and High Carb Meal Then High Fat Meal n=5 Participants 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.	Conditioned Stimulus+ (CS+) Then Conditioned Stimulus- (CS-), and High Carb Meal Then High Fat Meal n=3 Participants 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.	Total n=16 Participants Total of all reporting groups
Age, Continuous	30.0 years STANDARD_DEVIATION 7.0 • n=5 Participants	26.2 years STANDARD_DEVIATION 5.8 • n=7 Participants	30.0 years STANDARD_DEVIATION 8.1 • n=5 Participants	30.0 years STANDARD_DEVIATION 6.7 • n=4 Participants	29.3 years STANDARD_DEVIATION 6.6 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	16 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conditioned Stimulus + (CS+) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.	Conditioned Stimulus - (CS-) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.
Change in Preference- Liking	6.5 units on a scale Standard Deviation 10.7	4.5 units on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline and at 4 weeks

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.

Outcome measures

Outcome measures
Measure	Conditioned Stimulus + (CS+) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.	Conditioned Stimulus - (CS-) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.
Post-test Preference - Wanting	50.6 units on a scale Standard Deviation 120.	47.7 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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. Total beverage intake over 30 minutes is reported as the outcome.

Outcome measures

Outcome measures
Measure	Conditioned Stimulus + (CS+) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.	Conditioned Stimulus - (CS-) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.
Change in Preference- Wanting	187.4 ml Standard Deviation 152.2	147.3 ml Standard Deviation 140.6

SECONDARY outcome

Timeframe: 5-minute measurement

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Conditioned Stimulus + (CS+) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.	Conditioned Stimulus - (CS-) n=15 Participants Participants complete behavioral preference tests for conditions at baseline and after the conditioning paradigm in a post-test. All participants complete all conditions in a cross-over design.
Change in Preference- Wanting	9 Participants	6 Participants

SECONDARY outcome

Timeframe: 30-minute measurement that occurs during the post-test, approximately 4 weeks after the first study session

Population: 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.

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.