Trial Outcomes & Findings for Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism (NCT NCT04414644)
NCT ID: NCT04414644
Last Updated: 2025-03-11
Results Overview
To determine if timing of food consumption (daytime vs. delayed eating) affects body mass (kg).
COMPLETED
NA
17 participants
pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)
2025-03-11
Participant Flow
Participant milestones
| Measure |
Daytime Condition (8 Wks), Followed by Washout (2 Wks), Followed by Delayed Condition (8 Wks)
Participants were asked to eat on the Daytime condition first, eating all of their meals and snacks, as provided by the study, between 0800 and 1900 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Delayed condition when they ate their meals between 1200 and 2300 hr for 8 weeks.
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Delayed Condition (8 Wks), Followed by Washout (2 Wks), Followed by Daytime Condition (8 Wks)
Participants were asked to eat on the Delayed condition first when they ate their meals between 1200 and 2300 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Daytime condition, eating all of their meals and snacks, as provided by the study, between 0800 and 1900 hr for 8 weeks.
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|---|---|---|
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Overall Study
STARTED
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9
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8
|
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Overall Study
COMPLETED
|
7
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5
|
|
Overall Study
NOT COMPLETED
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2
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3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900 during the Daytime condition and between 1200 to 2300h in the Delayed condition.
Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will then have a 2-week washout period. They will complete the alternate eating condition for 8 weeks during eating condition 2.
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|---|---|
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Age, Continuous
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26.3 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · Asian
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3 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · Black or African American
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · White
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13 Participants
n=5 Participants
|
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Race (NIH/OMB)
Race · More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Weight
|
65.10 kg
STANDARD_DEVIATION 7.09 • n=5 Participants
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PRIMARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)Population: All participants completed both eating conditions in a cross-over design and are included in the analyses for the outcomes for each eating condition.
To determine if timing of food consumption (daytime vs. delayed eating) affects body mass (kg).
Outcome measures
| Measure |
Daytime Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 8 am and 7 pm for 8 weeks
|
Delayed Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 12 pm and 11 pm for 8 weeks.
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|---|---|---|
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Body Mass Changes Between the Daytime vs. Delayed Eating Conditions
|
-1.1 kg
Standard Deviation 1.6
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0.2 kg
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)Population: All participants were analyzed together for each outcome measure in this crossover study as all participants completed each eating condition.
Changes in fuel oxidation as measured by respiratory quotient with indirect calorimetry.
Outcome measures
| Measure |
Daytime Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 8 am and 7 pm for 8 weeks
|
Delayed Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 12 pm and 11 pm for 8 weeks.
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|---|---|---|
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Respiratory Quotient Changes in the Daytime vs Delayed Eating Conditions
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-.012 unitless
Standard Deviation .038
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-.021 unitless
Standard Deviation .062
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SECONDARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)Population: All participants were analyzed in for both eating conditions as this was a crossover study where participants completed both eating conditions.
Changes in resting energy expenditure as measured by indirect calorimetry before and after each eating condition.
Outcome measures
| Measure |
Daytime Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 8 am and 7 pm for 8 weeks
|
Delayed Eating Condition
n=12 Participants
Eating Condition: Participants will be randomly assigned to eat between 12 pm and 11 pm for 8 weeks.
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|---|---|---|
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Energy Expenditure Changes Between the Daytime and Delayed Eating Conditions
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-93.66 kcal/day
Standard Deviation 97.74
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24.35 kcal/day
Standard Deviation 182.90
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Adverse Events
Daytime Eating Condition Followed by 2 Week Washout, Followed by Delayed Eating Condition
Delayed Eating Condition Followed by 2 Week Washout, Followed by Daytime Eating Condition
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