Trial Outcomes & Findings for The Impact of the Physiological Response to Sugar on Brain Activity and Behavior (NCT NCT06015490)

NCT ID: NCT06015490

Last Updated: 2025-09-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Immediately after informed consent and in the post-test session approximately 5 weeks later

Results posted on

2025-09-11

Participant Flow

Participant milestones

Participant milestones
Measure
Sucrose, Then Glucose, Then Fructose
Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.
Sucrose, Then Fructose, Then Glucose
Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.
Glucose, Then Fructose, Then Sucrose
Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.
Glucose, Then Sucrose, Then Fructose
Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.
Fructose, Then Glucose, Then Sucrose
Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.
Fructose, Then Sucrose, Then Glucose
Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.
First CS Intervention (1 Week)
STARTED
1
2
0
1
1
2
First CS Intervention (1 Week)
COMPLETED
1
2
0
1
1
2
First CS Intervention (1 Week)
NOT COMPLETED
0
0
0
0
0
0
Second CS Intervention (1 Week)
STARTED
1
2
0
1
1
2
Second CS Intervention (1 Week)
COMPLETED
1
2
0
1
1
1
Second CS Intervention (1 Week)
NOT COMPLETED
0
0
0
0
0
1
Third CS Intervention (1 Week)
STARTED
1
2
0
1
1
1
Third CS Intervention (1 Week)
COMPLETED
1
2
0
1
1
1
Third CS Intervention (1 Week)
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of the Physiological Response to Sugar on Brain Activity and Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sucrose, Then Glucose, Then Fructose
n=1 Participants
Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.
Sucrose, Then Fructose, Then Glucose
n=2 Participants
Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.
Glucose, Then Fructose, Then Sucrose
Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.
Glucose, Then Sucrose, Then Fructose
n=1 Participants
Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.
Fructose, Then Glucose, Then Sucrose
n=1 Participants
Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.
Fructose, Then Sucrose, Then Glucose
n=2 Participants
Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.
Total
n=7 Participants
Total of all reporting groups
Age, Continuous
25 years
STANDARD_DEVIATION 0 • n=99 Participants
28.5 years
STANDARD_DEVIATION 0.7 • n=107 Participants
42 years
STANDARD_DEVIATION 0 • n=7 Participants
31 years
STANDARD_DEVIATION 0 • n=31 Participants
22 years
STANDARD_DEVIATION 1.4 • n=30 Participants
28.4 years
STANDARD_DEVIATION 6.9 • n=3 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
1 Participants
n=30 Participants
2 Participants
n=3 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
1 Participants
n=30 Participants
5 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
2 Participants
n=30 Participants
7 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
2 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
2 Participants
n=30 Participants
4 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Region of Enrollment
United States
1 participants
n=99 Participants
2 participants
n=107 Participants
1 participants
n=7 Participants
1 participants
n=31 Participants
2 participants
n=30 Participants
7 participants
n=3 Participants

PRIMARY outcome

Timeframe: Immediately after informed consent and in the post-test session approximately 5 weeks later

Subjective ratings of liking of flavors used in the intervention will be assessed at baseline and after the intervention. The generalized Labeled Magnitude Scale will be used. The scale is anchored by descriptors of "Most Disliked Sensation Imaginable" and "Most Liked Sensation Imaginable" at the lower and upper ends, respectively. The score is determined by the place on the scale participants select (range of scale is 0-100). An increase in score from baseline to post-intervention indicates an increase in liking.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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- Subjective Liking Ratings for Each Beverage on a Scale
-12.8 units on a scale
Standard Deviation 26.3
-12.0 units on a scale
Standard Deviation 26.2
-12.6 units on a scale
Standard Deviation 26.3

SECONDARY outcome

Timeframe: At the end of study; approximately 5 weeks after first session

Subjective ratings of liking of flavors used in the intervention will be assessed at baseline and after the intervention. A Visual Analog Scale will be used. Participants select a place on the line that corresponds with their subjective rating, and the score is determined by the place selected (range of scores is 0-100). The line is anchored by polar opposite descriptors ("Do not want at all" and "Want very much"). An increase in score from baseline to post-intervention indicates and increase in wanting.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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 Measure of Preference- Subjective Wanting Ratings for Each Beverage on a Scale
42 units on a scale
Standard Deviation 12.7
54.8 units on a scale
Standard Deviation 12.5
46.9 units on a scale
Standard Deviation 14.5

SECONDARY outcome

Timeframe: At the end of study; approximately 5 weeks after first session

Ad libitum intake will be used as a measure of wanting in a post-test session. Participants will be provided each beverage used during the intervention and asked to drink as much or as little of them as they would like over a 30-minute period.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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 Measure of Preference - Wanting (ad Libitum Intake): The Amount Consumed of Each Beverage is Reported as the Outcome
67.8 ml consumed
Standard Deviation 98.1
66.0 ml consumed
Standard Deviation 99.1
66.3 ml consumed
Standard Deviation 98.5

SECONDARY outcome

Timeframe: At the end of study; approximately 5 weeks after first session

Population: In the post-test session, participants are asked to choose among the Glucose, Sucrose, and Fructose Drinks which they would like to take home in a forced choice test. Participants are only allowed to choose one of the three conditions.

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.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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 Measure of Preference- Wanting (Forced Choice): Number of Participants Who Chose Each Indicated Beverage
1 Participants
3 Participants
2 Participants

SECONDARY outcome

Timeframe: At the end of study; approximately 5 weeks after first session

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. Participants receive the glucose, sucrose, fructose, and tasteless (control) solutions 18 times each over the course of 2 runs. Contrasts of interest are the blood oxygen level-dependent (BOLD) response of glucose+\>tasteless solution, sucrose\>tasteless solution, and fructose\>tasteless deliveries. Parameter estimates for these contrasts are extracted and reported. A positive outcome reflects greater whole-brain BOLD response for the sugar condition compared with a tasteless solution.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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.
Blood Oxygen Level-dependent (BOLD) Response to Beverages
0.005 arbitrary units
Standard Deviation 0.085
0.109 arbitrary units
Standard Deviation 0.186
0.050 arbitrary units
Standard Deviation 0.210

SECONDARY outcome

Timeframe: Each week for 3 weeks during the study

Population: One participant withdrew from the study prior to the glucose and sucrose drink sessions but completed the fructose drink session.

Blood glucose will be assessed at baseline and at set time points for 2 hours after consumption of intervention beverages (baseline, 5-, 20-, 40-, 60-, 90-, and 120-minutes after drink consumption)in one exposure session. Area under the curve is calculated using these time points and reported as the outcome measure.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=6 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.
Fructose Drink
n=7 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.
Sucrose Drink
n=6 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.
Blood Glucose Response to Beverages
16821.25 mg/dl*min
Standard Deviation 4861.348755
11484.58334 mg/dl*min
Standard Deviation 1468.61789
13760.66666 mg/dl*min
Standard Deviation 3813.485448

SECONDARY outcome

Timeframe: Each week for 3 weeks during the study

Population: Technical challenges with equipment and data collection resulted in lower sample size for analysis for this outcome.

Indirect calorimetry will be used to determine energy expenditure at baseline and for 120 minutes after consumption of condition beverages in an exposure session. Area under the curve is calculated as a change from baseline energy expenditure using minute-by-minute resolution across 120 minutes and reported as the outcome measure.

Outcome measures

Outcome measures
Measure
Glucose Drink
n=5 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.
Fructose Drink
n=6 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.
Sucrose Drink
n=6 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.
Energy Expenditure in Response to Beverages
-0.89 kcal/min*min
Standard Deviation 6.63
0.940 kcal/min*min
Standard Deviation 6.14
1.89 kcal/min*min
Standard Deviation 3.86

Adverse Events

Sucrose Drink

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fructose Drink

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Glucose Drink

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexandra DiFeliceantonio

Virginia Polytechnic Institute and State University

Phone: 540-526-2285

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place