Time Restricted EatingNCT06145009
Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women
A study testing Time restricted eating in people with Time Restricted Eating and Eating Behavior, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to assess how time restricted eating interventions impact eating behaviors, diet quality, and body composition in women ages 20-29 years. Participants will be asked to limit all food and drinks (except water and some non-caloric beverages) to a 10-hour period during the day for four weeks. Read more about this study
- Who is it for?
- Ages 20 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Eating, Eating Behavior, Diet, Healthy
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to speak and read English
- Own a smartphone
- BMI ≥ 20 kg/m2
- Usual eating window ≥ 12 hours with the last eating occasion after 8pm on the majority of days
- Have at least a moderate baseline level of dietary restraint
Who cannot join
- Shift workers
- Being pregnant, nursing, or planning to become pregnant in the next 6 months
- Having a past or current eating disorder diagnosis
- Having a chronic medical condition (including diabetes, heart, kidney, or thyroid disease) or a condition that requires therapeutic diet or specified meal timing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess how time restricted eating interventions impact eating behaviors, diet quality, and body composition in women ages 20-29 years. Participants will be asked to limit all food and drinks (except water and some non-caloric beverages) to a 10-hour period during the day for four weeks. Participants 1-36 will follow their usual eating and activity patterns for one week before starting, and follow whatever eating pattern they want for 4 weeks after finishing. Participants 37-51 will follow their usual eating and activity patterns for one week before starting, and will not complete a follow up period.
- Being tested
- Time restricted eating
- Medical subject headings
- Intermittent Fasting, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called Time restricted feeding, Intermittent fasting, Meal timing
Limit food intake to 10 hours per day as described in the experimental arm section.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating | Experimental | Participants will limit their eating (all food and caloric beverages) to an eating window of 10 hours per day for 4 weeks. The eating window must end by 8pm. Water and non-caloric beverages are allowed outside of the eating window. No other changes are required to the types or total amount of food eaten. Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Eating
Dutch Eating Behavior Questionnaire: Emotional Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher emotional eating.
Measured: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
External Eating
Dutch Eating Behavior Questionnaire: External Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher external eating.
Measured: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Eating in the Absence of Hunger
Assessed through surveys sent 5x/day asking about if food was eaten and why.
Measured: Participants 1-36: Baseline week, weeks 1 and 4 of intervention, weeks 1 and 4 of follow up Participants 37-51: Baseline week, weeks 1 and 4 of intervention
Secondary outcomes (5)
Diet Quality
Healthy Eating Index, calculated from 3-day food records. The Healthy Eating Index is scored from 0-100, with higher scores indicating higher diet quality.
Measured: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Body composition (total percent body fat)
Percent body fat measured by DXA
Measured: Baseline and end of 4-week intervention (participants 1-36 only)
Body composition (visceral fat)
Visceral fat measured by DXA
Measured: Baseline and end of 4-week intervention (participants 1-36 only)
Body weight
Total body weight
Measured: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Continuous Glucose Monitoring
Participants will wear a Dexcom continuous glucose monitor
Measured: First 10 days of study, last 7 days of intervention period (added for participants 37-51, optional for participants 29-36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start30 Oct 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Time Restricted EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly R Pacanowski, University of Delaware
- Investigators
- Carly Pacanowski, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145009
- Sponsor's protocol ID
- 2089190-1
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vizthum D, Earthman CP, Patterson F, Melough MM, Allison KC, Pacanowski CR. Four-week time restricted eating intervention is associated with improvements in cardiometabolic risk factors and dysregulated eating among emerging adult women: a single-armed trial. Eat Weight Disord. 2026 May 8;31(1):71. doi: 10.1007/s40519-026-01814-y.
PubMed 42104042
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women
- ClinicalTrials.gov ID
- NCT06145009
- Acronym / sponsor ID
- 2089190-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess how time restricted eating interventions impact eating behaviors, diet quality, and body composition in women ages 20-29 years. Participants will be asked to limit all food and drinks (except water and some non-caloric beverages) to a 10-hour period during the day for four weeks. Participants 1-36 will follow their usual eating and activity patterns for one week before starting, and follow whatever eating pattern they want for 4 weeks after finishing. Participants 37-51 will follow their usual eating and activity patterns for one week before starting, and will not complete a follow up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time restricted eatingParticipants will limit their eating (all food and caloric beverages) to an eating window of 10 hours per day for 4 weeks. The eating window must end by 8pm. Water and non-caloric beverages are allowed outside of the eating window. No other changes are required to the types or total amount of food eaten. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to speak and read English
- Own a smartphone
- BMI ≥ 20 kg/m2
- Usual eating window ≥ 12 hours with the last eating occasion after 8pm on the majority of days
- Have at least a moderate baseline level of dietary restraint
Key exclusion criteria (4 listed)
- Shift workers
- Being pregnant, nursing, or planning to become pregnant in the next 6 months
- Having a past or current eating disorder diagnosis
- Having a chronic medical condition (including diabetes, heart, kidney, or thyroid disease) or a condition that requires therapeutic diet or specified meal timing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingAlso: Time restricted feeding, Intermittent fasting, Meal timingLimit food intake to 10 hours per day as described in the experimental arm section. | Behavioural | Time Restricted Eating |
Primary outcome
Emotional Eating
Time frame: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Dutch Eating Behavior Questionnaire: Emotional Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher emotional eating.
External Eating
Time frame: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Dutch Eating Behavior Questionnaire: External Eating Subscale. This subscale is scored from 1-5, with higher scores indicating higher external eating.
Eating in the Absence of Hunger
Time frame: Participants 1-36: Baseline week, weeks 1 and 4 of intervention, weeks 1 and 4 of follow up Participants 37-51: Baseline week, weeks 1 and 4 of intervention
Assessed through surveys sent 5x/day asking about if food was eaten and why.
5 secondary outcomes
Diet Quality
Time frame: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Body composition (total percent body fat)
Time frame: Baseline and end of 4-week intervention (participants 1-36 only)
Body composition (visceral fat)
Time frame: Baseline and end of 4-week intervention (participants 1-36 only)
Body weight
Time frame: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention
Continuous Glucose Monitoring
Time frame: First 10 days of study, last 7 days of intervention period (added for participants 37-51, optional for participants 29-36)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 42104042Vizthum D, Earthman CP, Patterson F, Melough MM, Allison KC, Pacanowski CR. Four-week time restricted eating intervention is associated with improvements in cardiometabolic risk factors and dysregulated eating among emerging adult women: a single-armed trial. Eat Weight Disord. 2026 May 8;31(1):71. doi: 10.1007/s40519-026-01814-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly Pacanowski, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Time Restricted Eating and Eating Behavior, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Eating (time frame: Participants 1-36: 3 time points: baseline, end of 4-week intervention, end of 4-week follow up Participants 37-51: 2 time points: baseline, end of 4-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.