Trial Outcomes & Findings for Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake (NCT NCT03407053)
NCT ID: NCT03407053
Last Updated: 2021-06-29
Results Overview
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
14 days
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
Ultra-processed Diet Then Unprocessed Diet
Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks
Ultra-processed diet: Consuming ultra-processed diet over a 2-week period
Unprocessed diet: Consuming unprocessed diet over a 2-week period
|
Unprocessed Diet Then Ultra-processed Diet
Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks
Ultra-processed diet: Consuming ultra-processed diet over a 2-week period
Unprocessed diet: Consuming unprocessed diet over a 2-week period
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
Baseline characteristics by cohort
| Measure |
Ultra-processed Diet Then Unprocessed Diet
n=10 Participants
Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks
Ultra-processed diet: Consuming ultra-processed diet over a 2-week period
Unprocessed diet: Consuming unprocessed diet over a 2-week period
|
Unprocessed Diet Then Ultra-processed Diet
n=10 Participants
Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks
Ultra-processed diet: Consuming ultra-processed diet over a 2-week period
Unprocessed diet: Consuming unprocessed diet over a 2-week period
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
30.1 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
31.2 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Body weight
|
77.3 kg
STANDARD_DEVIATION 21.1 • n=99 Participants
|
79.3 kg
STANDARD_DEVIATION 22.4 • n=107 Participants
|
78.3 kg
STANDARD_DEVIATION 21.2 • n=206 Participants
|
|
Fat mass
|
23.1 kg
STANDARD_DEVIATION 13.4 • n=99 Participants
|
26.0 kg
STANDARD_DEVIATION 14.2 • n=107 Participants
|
24.6 kg
STANDARD_DEVIATION 13.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 14 daysAd libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Outcome measures
| Measure |
Ultra-processed Diet
n=20 Participants
Consuming ultra-processed diet over a 14 day period
|
Unprocessed Diet
n=20 Participants
Consuming unprocessed diet over a 14 day period
|
|---|---|---|
|
Ad Libitum Energy Intake
|
2963 kcal per day
Standard Error 74.3
|
2491 kcal per day
Standard Error 74.3
|
SECONDARY outcome
Timeframe: Baseline and day 14Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Outcome measures
| Measure |
Ultra-processed Diet
n=20 Participants
Consuming ultra-processed diet over a 14 day period
|
Unprocessed Diet
n=20 Participants
Consuming unprocessed diet over a 14 day period
|
|---|---|---|
|
Change in Body Weight
|
0.94 kg
Standard Error 0.31
|
-0.91 kg
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline and day 14Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.
Outcome measures
| Measure |
Ultra-processed Diet
n=20 Participants
Consuming ultra-processed diet over a 14 day period
|
Unprocessed Diet
n=19 Participants
Consuming unprocessed diet over a 14 day period
|
|---|---|---|
|
Change in Fat Mass
|
0.43 kg
Standard Error 0.11
|
-0.28 kg
Standard Error 0.11
|
Adverse Events
Ultra-processed Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unprocessed Diet
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place