NCT06015490

Brief Summary

The goal of this pilot study is to test the feasibility of assessing how biological factors and chemical properties of sugars may influence metabolism and food reward in humans. The main questions it aims to answer are: • Can differences in appetitive responses and neural activations to sucrose (table sugar) and its chemical components (glucose and fructose) be measured and quantified? This study is a crossover design, meaning every participant will complete every condition. Participants will consume beverages containing sucrose, glucose, or fructose, which are each novelly flavored, 6 times within a week. During one of the consumption times, energy expenditure, carbohydrate oxidation, and blood glucose will be measured in the lab before and for 2 hours after consumption. After participants have consumed each condition, they will undergo a tasting task in the MRI scanner, neural responses to receipt of the beverages are measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 11, 2025

Completed
Last Updated

September 11, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

May 3, 2023

Results QC Date

July 1, 2025

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Preference- Subjective Liking Ratings for Each Beverage on a Scale

    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.

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

Secondary Outcomes (6)

  • Post-Test Measure of Preference- Subjective Wanting Ratings for Each Beverage on a Scale

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

  • Post-Test Measure of Preference - Wanting (ad Libitum Intake): The Amount Consumed of Each Beverage is Reported as the Outcome

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

  • Post-Test Measure of Preference- Wanting (Forced Choice): Number of Participants Who Chose Each Indicated Beverage

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

  • Blood Oxygen Level-dependent (BOLD) Response to Beverages

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

  • Blood Glucose Response to Beverages

    Each week for 3 weeks during the study

  • +1 more secondary outcomes

Study Arms (6)

Sucrose, then Glucose, then Fructose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Sucrose, then Fructose, then Glucose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Glucose, then Fructose, then Sucrose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Glucose, then Sucrose, then Fructose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Fructose, then Glucose, then Sucrose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Fructose, then Sucrose, then Glucose

EXPERIMENTAL

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.

Other: Sucrose drinkOther: Glucose drinkOther: Fructose drink

Interventions

Participants will consume flavored beverage solutions containing 110 calories of sucrose in 6 exposure sessions within 1 week. One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period. The other 5 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.

Also known as: Flavored beverage solution with 110 calories of sucrose
Fructose, then Glucose, then SucroseFructose, then Sucrose, then GlucoseGlucose, then Fructose, then SucroseGlucose, then Sucrose, then FructoseSucrose, then Fructose, then GlucoseSucrose, then Glucose, then Fructose

Participants will consume flavored beverage solutions containing 110 calories of glucose in 6 exposure sessions within 1 week. One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period. The other 5 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.

Also known as: Flavored beverage solution with 110 calories of glucose
Fructose, then Glucose, then SucroseFructose, then Sucrose, then GlucoseGlucose, then Fructose, then SucroseGlucose, then Sucrose, then FructoseSucrose, then Fructose, then GlucoseSucrose, then Glucose, then Fructose

Participants will consume flavored beverage solutions containing 110 calories of fructose in 6 exposure sessions within 1 week. One exposure session will include pre- and post-consumption blood draws and indirect calorimetry measurements inside a metabolic chamber over a 2-hour period. The other 5 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.

Also known as: Flavored beverage solution with 110 calories of fructose
Fructose, then Glucose, then SucroseFructose, then Sucrose, then GlucoseGlucose, then Fructose, then SucroseGlucose, then Sucrose, then FructoseSucrose, then Fructose, then GlucoseSucrose, then Glucose, then Fructose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.5-25 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 (FBRI) at Virginia Tech Carilion
  • Weigh at least 110 lbs

You may not qualify if:

  • Current inhaled nicotine use
  • History of alcohol dependence.
  • Current or past diagnosis of cardiometabolic disease or problems, including diabetes, endocrine, heart, or thyroid problems, that may influence study outcomes
  • Hemoglobin A1C \>5.7%
  • Taking medications known to influence study measures (including attention-deficit/hyperactivity disorder (ADHD), allergy, antidepressant, antipsychotic, anxiolytic, birth control, blood pressure, blood glucose, cholesterol, thyroid, sleep, or weight loss medications)
  • Active medical or neurologic disorder, including cardiometabolic conditions or gastrointestinal conditions that may influence study outcomes
  • 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
  • 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 bioelectrical impedance analysis, specifically implanted devices
  • Use of substances (or combinations of substances) in doses and frequencies that could influence neural outcomes of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at Virginia Tech Carilion

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Food PreferencesAppetitive Behavior

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorBehavior, Animal

Results Point of Contact

Title
Alexandra DiFeliceantonio
Organization
Virginia Polytechnic Institute and State University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2023

First Posted

August 29, 2023

Study Start

September 1, 2023

Primary Completion

July 22, 2024

Study Completion

July 22, 2024

Last Updated

September 11, 2025

Results First Posted

September 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations