Trial Outcomes & Findings for Young Adult Eating Habits (NCT NCT05550818)
NCT ID: NCT05550818
Last Updated: 2026-01-12
Results Overview
Brain response to milkshake was measured using functional magnetic resonance imaging (fMRI). On the first level a contrast of milkshake \> tasteless was built. The measures presented here are the beta values of the milkshake\>tasteless contrast extracted from an orbital frontal cortex apriori region of interest. The pre intervention beta values were subtracted from the post intervention values. Extracted beta values are by definition arbitrary units and are the standard measure for fMRI.
COMPLETED
NA
36 participants
4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
2026-01-12
Participant Flow
36 individuals were screened for eligibility between March 10, 2023 and September 1, 2024 in Blacksburg, VA.
33 of 36 participants were randomized. Of those not randomized, 1 did not meet inclusion criteria, 1 was lost to follow up, and 1 voluntarily withdrew due to time commitment.
Participant milestones
| Measure |
High Ultra Processed Food Diet First, Then No Ultra Processed Food Diet
Participants will consume a diet containing 81% total energy from UPF for 2 weeks.
High Ultra Processed Food Diet: Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 0% total energy from UPF for 2 weeks.
|
No Ultra Processed Food Diet First, Then Ultra Processed Food Diet
Participants will consume a diet containing 0% total energy from UPF for 2 weeks.
No Ultra Processed Food Diet: Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 81% total energy from UPF for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
High Ultra Processed Food Diet First, Then No Ultra Processed Food Diet
Participants will consume a diet containing 81% total energy from UPF for 2 weeks.
High Ultra Processed Food Diet: Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 0% total energy from UPF for 2 weeks.
|
No Ultra Processed Food Diet First, Then Ultra Processed Food Diet
Participants will consume a diet containing 0% total energy from UPF for 2 weeks.
No Ultra Processed Food Diet: Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 81% total energy from UPF for 2 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Young Adult Eating Habits
Baseline characteristics by cohort
| Measure |
High Ultra Processed Food Diet First
n=15 Participants
Participants will consume a diet containing 81% total energy from UPF for 2 weeks.
High Ultra Processed Food Diet: Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 0% total energy from UPF for 2 weeks.
|
No Ultra Processed Food Diet First
n=18 Participants
Participants will consume a diet containing 0% total energy from UPF for 2 weeks.
No Ultra Processed Food Diet: Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 81% total energy from UPF for 2 weeks.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.73 years
STANDARD_DEVIATION 2.15 • n=210 Participants
|
22.00 years
STANDARD_DEVIATION 1.97 • n=19 Participants
|
21.88 years
STANDARD_DEVIATION 2.03 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=210 Participants
|
12 Participants
n=19 Participants
|
22 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=210 Participants
|
16 Participants
n=19 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
2 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=210 Participants
|
13 Participants
n=19 Participants
|
23 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=210 Participants
|
18 participants
n=19 Participants
|
33 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)Population: Of the 28 participants that completed the study, 24 were analyzed. Data collection was not completed for one participant due to a power outage. 2 participants were excluded due to excess motion in the scanner. 1 participant was ill at the time of assessment.
Brain response to milkshake was measured using functional magnetic resonance imaging (fMRI). On the first level a contrast of milkshake \> tasteless was built. The measures presented here are the beta values of the milkshake\>tasteless contrast extracted from an orbital frontal cortex apriori region of interest. The pre intervention beta values were subtracted from the post intervention values. Extracted beta values are by definition arbitrary units and are the standard measure for fMRI.
Outcome measures
| Measure |
High Ultra Processed Food Diet
n=24 Participants
Participants will consume a diet containing 81% total energy from UPF for 2 weeks.
High Ultra Processed Food Diet: Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 0% total energy from UPF for 2 weeks.
|
No Ultra Processed Food Diet
n=24 Participants
Participants will consume a diet containing 0% total energy from UPF for 2 weeks.
No Ultra Processed Food Diet: Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
Next, participants will consume a diet containing 81% total energy from UPF for 2 weeks.
|
|---|---|---|
|
Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet
|
0.02 arbitrary units
Standard Deviation 0.51
|
0.13 arbitrary units
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)Participants will arrive at the laboratory in the fasted state for an ad libitum breakfast buffet meal. The buffet meal will contain a variety of food items that vary in macronutrient content and in their degree of processing (UPF, no UPF). The meal will consist of typical breakfast items in excess of what would normally be consumed. Participants will self-select foods over a 30-minute period. Food items will be weighed (±0.1 grams) prior to and after the completion of the meal to determine the amount consumed (g, kcal), calculated using NDSR nutritional analysis software.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)Participants will arrive at the laboratory in the fasted state for an ad libitum breakfast buffet meal. The buffet meal will contain a variety of food items that vary in macronutrient content and in their degree of processing (UPF, no UPF). The meal will consist of typical breakfast items in excess of what would normally be consumed. Participants will self-select foods over a 30-minute period. Meal eating rate (g/min, kcal/min) will be determined using meal start and stop times.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)At the ad libitum buffet meal, food selection will be determined by the number of items consumed from UPF vs no UPF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)At the ad libitum buffet meal, food selection will be determined by the number of grams consumed from UPF vs no UPF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)At the ad libitum buffet meal, food selection will be determined by the number of amount of energy (kcals) consumed from UPF vs no UPF.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)Participants will undergo computerized tests of executive function, such as working memory, cognitive flexibility, and inhibitory control. These tasks have been widely used with participants across the lifespan and contain simple graphics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 measurements (in person and take home portion following the 2-week UPF diet, in person and take home portion following the 2-week no UPF diet)Following the ad libitum buffet meal, participants will move to a separate room where an ample amount of 4 pre-weighed snack items (2 UPF, 2 no UPF) and magazines are available. Using an approach consistent with previous research studying this outcome, participants will be instructed to take 2 bites of each snack item and rate its palatability on the LHS, and to eat the remainder of the snacks or look at the magazines while they wait for the next part of the study. Participants will be left to consume the snacks or relax for 15 minutes. Participants will also be given a box of snacks to assess eating in the absence of hunger outside the laboratory environment. Snack boxes will be returned to study staff the next morning. Staff will document the amount and type of snacks consumed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)To assess sensations of hunger a Visual Analog Scale bounded by "not hungry at all" and "extremely hungry" will be used. With higher scores indicated higher hunger. Same for fullness. Visual Analog Scales will be completed prior to (min. 0), and following the buffet meal (min. 30).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)To assess sensitivity to delayed consequences by assessing preference for different amounts of money varying over different amounts of time. This will be associated with a k value (discount rate), the lower the k value, the less discounting.
Outcome measures
Outcome data not reported
Adverse Events
High Ultra Processed Food Diet First
No Ultra Processed Food Diet First
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place