Trial Outcomes & Findings for Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism (NCT NCT05290064)
NCT ID: NCT05290064
Last Updated: 2026-08-12
Results Overview
Energy intake averaged over 7 days for each diet, measured in kilocalories (kcal) per day. Primary comparisons will be between UPF HH \& UPF HL, UPF HL \& UPF LL, UPF LL \& UNF LL, UPF HH \& UNF LL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Four 1-week diets
Results posted on
2026-08-12
Participant Flow
Adult subjects were recruited to the study via the NIH Patient Recruitment and Public Liaison Office from 11/24/2022 to 8/15/2025.
Participant milestones
| Measure |
1/UPF HH, UPF HL, UNF LL, UPF LL
Four diets in the following order: ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF high in non-beverage energy density and low hyperpalatable foods (HL); Unprocessed food (UNF) with low non-beverage energy density and low hyperpalatable foods (LL); UPF low in both non-beverage energy density and hyperpalatable foods (LL).
|
2/ UPF HL, UPF LL, UPF HH, UNF LL
Four diets in the following order: ultra-processed food (UPF) high in non-beverage energy density and low hyperpalatable foods (HL); UPF low in both non-beverage energy density and hyperpalatable foods; UPF high in both non-beverage energy density and hyperpalatable foods (HH); Unprocessed food with low non-beverage energy density and low hyperpalatable foods.
|
3/ UPF LL, UNF LL, UPF HL, UPF HH
Four diets in the following order: ultra-processed food (UPF) with low non-beverage energy density and low hyperpalatable foods (LL); Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL); UPF high in both non-beverage energy density and hyperpalatable foods (HH).
|
4/ UNF LL, UPF HH, UPF LL, UPF HL
Four diets in the following order: Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL);ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF with low non-beverage energy density and low hyperpalatable foods (LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
1/UPF HH, UPF HL, UNF LL, UPF LL
Four diets in the following order: ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF high in non-beverage energy density and low hyperpalatable foods (HL); Unprocessed food (UNF) with low non-beverage energy density and low hyperpalatable foods (LL); UPF low in both non-beverage energy density and hyperpalatable foods (LL).
|
2/ UPF HL, UPF LL, UPF HH, UNF LL
Four diets in the following order: ultra-processed food (UPF) high in non-beverage energy density and low hyperpalatable foods (HL); UPF low in both non-beverage energy density and hyperpalatable foods; UPF high in both non-beverage energy density and hyperpalatable foods (HH); Unprocessed food with low non-beverage energy density and low hyperpalatable foods.
|
3/ UPF LL, UNF LL, UPF HL, UPF HH
Four diets in the following order: ultra-processed food (UPF) with low non-beverage energy density and low hyperpalatable foods (LL); Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL); UPF high in both non-beverage energy density and hyperpalatable foods (HH).
|
4/ UNF LL, UPF HH, UPF LL, UPF HL
Four diets in the following order: Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL);ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF with low non-beverage energy density and low hyperpalatable foods (LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL).
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
Baseline characteristics by cohort
| Measure |
1/UPF HH, UPF HL, UNF LL, UPF LL
n=9 Participants
Four diets in the following order: ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF high in non-beverage energy density and low hyperpalatable foods (HL); Unprocessed food (UNF) with low non-beverage energy density and low hyperpalatable foods (LL); UPF low in both non-beverage energy density and hyperpalatable foods (LL).
|
2/ UPF HL, UPF LL, UPF HH, UNF LL
n=9 Participants
Four diets in the following order: ultra-processed food (UPF) high in non-beverage energy density and low hyperpalatable foods (HL); UPF low in both non-beverage energy density and hyperpalatable foods; UPF high in both non-beverage energy density and hyperpalatable foods (HH); Unprocessed food with low non-beverage energy density and low hyperpalatable foods.
|
3/ UPF LL, UNF LL, UPF HL, UPF HH
n=9 Participants
Four diets in the following order: ultra-processed food (UPF) with low non-beverage energy density and low hyperpalatable foods (LL); Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL); UPF high in both non-beverage energy density and hyperpalatable foods (HH).
|
4/ UNF LL, UPF HH, UPF LL, UPF HL
n=9 Participants
Four diets in the following order: Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL);ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH); UPF with low non-beverage energy density and low hyperpalatable foods (LL); UPF high in non-beverage energy density and low hyperpalatable foods (HL).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.44 year
STANDARD_DEVIATION 7.18 • n=1 Participants
|
37.44 year
STANDARD_DEVIATION 11.68 • n=1 Participants
|
31.00 year
STANDARD_DEVIATION 14.17 • n=1 Participants
|
39.33 year
STANDARD_DEVIATION 11.05 • n=2 Participants
|
36.31 year
STANDARD_DEVIATION 11.27
|
|
Sex: Female, Male
Female
|
4 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=2 Participants
|
14 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
5 Participants
n=2 Participants
|
22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
11 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
7 Participants
n=2 Participants
|
16 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
8 Participants
n=2 Participants
|
31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Body Weight
|
100.46 kilogram
STANDARD_DEVIATION 25.03 • n=1 Participants
|
91.67 kilogram
STANDARD_DEVIATION 29.23 • n=1 Participants
|
78.97 kilogram
STANDARD_DEVIATION 21.19 • n=1 Participants
|
84.22 kilogram
STANDARD_DEVIATION 16.31 • n=2 Participants
|
88.83 kilogram
STANDARD_DEVIATION 23.86
|
|
Body Mass Index
|
33.28 kilogram per square meter
STANDARD_DEVIATION 9.58 • n=1 Participants
|
29.41 kilogram per square meter
STANDARD_DEVIATION 7.17 • n=1 Participants
|
27.45 kilogram per square meter
STANDARD_DEVIATION 5.44 • n=1 Participants
|
28.01 kilogram per square meter
STANDARD_DEVIATION 4.51 • n=2 Participants
|
29.54 kilogram per square meter
STANDARD_DEVIATION 7.03
|
PRIMARY outcome
Timeframe: Four 1-week dietsEnergy intake averaged over 7 days for each diet, measured in kilocalories (kcal) per day. Primary comparisons will be between UPF HH \& UPF HL, UPF HL \& UPF LL, UPF LL \& UNF LL, UPF HH \& UNF LL.
Outcome measures
| Measure |
UPF hh
n=36 Participants
Energy intake on UPF hh diet
|
UPF hl
n=36 Participants
Energy intake on UPF hl diet
|
UPF ll
n=36 Participants
Energy intake on UPF ll diet
|
UNF ll
n=36 Participants
Energy intake on UNF ll diet
|
|---|---|---|---|---|
|
Energy Intake (kcal Per Day)
|
3424.3 kcal/day
Standard Error 108.5
|
3265.9 kcal/day
Standard Error 108.5
|
2604.4 kcal/day
Standard Error 108.5
|
2476.0 kcal/day
Standard Error 108.5
|
SECONDARY outcome
Timeframe: Four 1-week dietsThis will be determined by the measured duration of the meals along with the measured mass of food consumed.
Outcome measures
| Measure |
UPF hh
n=36 Participants
Energy intake on UPF hh diet
|
UPF hl
n=36 Participants
Energy intake on UPF hl diet
|
UPF ll
n=36 Participants
Energy intake on UPF ll diet
|
UNF ll
n=36 Participants
Energy intake on UNF ll diet
|
|---|---|---|---|---|
|
Meal Eating Rate (Grams Per Minute)
|
39.21 gram/min
Standard Error 2.52
|
39.02 gram/min
Standard Error 2.52
|
39.04 gram/min
Standard Error 2.52
|
38.43 gram/min
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Four 1-week dietsMeal Palatability will be measured via questionnaires using visual analogue scales. The range of VAS is 0-100, where 0 = "Not at all palatable" and 100 = "Extremely palatable"
Outcome measures
| Measure |
UPF hh
n=36 Participants
Energy intake on UPF hh diet
|
UPF hl
n=36 Participants
Energy intake on UPF hl diet
|
UPF ll
n=36 Participants
Energy intake on UPF ll diet
|
UNF ll
n=36 Participants
Energy intake on UNF ll diet
|
|---|---|---|---|---|
|
Meal Palatability
|
65.24 Score on a scale
Standard Error 3.16
|
62.41 Score on a scale
Standard Error 3.13
|
66.67 Score on a scale
Standard Error 3.13
|
64.18 Score on a scale
Standard Error 3.1
|
Adverse Events
UPF HH
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
UPF HL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UPF LL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UNF LL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
UPF HH
n=36 participants at risk
ultra-processed food (UPF) high in both non-beverage energy density and hyperpalatable foods (HH)
|
UPF HL
n=36 participants at risk
ultra-processed food (UPF) high in non-beverage energy density and low hyperpalatable foods (HL)
|
UPF LL
n=36 participants at risk
ultra-processed food (UPF) with low non-beverage energy density and low hyperpalatable foods (LL)
|
UNF LL
n=36 participants at risk
Unprocessed food with low non-beverage energy density and low hyperpalatable foods (UNF LL)
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Right foot pain; mild severity grade; recovered without sequelae; treated with pain medication
|
2.8%
1/36 • From enrollment through the end of the study (exactly 4 weeks to complete all four dietary interventions).
|
0.00%
0/36 • From enrollment through the end of the study (exactly 4 weeks to complete all four dietary interventions).
|
0.00%
0/36 • From enrollment through the end of the study (exactly 4 weeks to complete all four dietary interventions).
|
2.8%
1/36 • From enrollment through the end of the study (exactly 4 weeks to complete all four dietary interventions).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place