OverweightNCT05660291
A Study of Time Restricted Eating in Obese Adults
A study testing Early time-restricted eating and Late time-restricted eating in people with Overweight, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Overweight
- What is being tested?
- Early time-restricted eating and Late time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to read and understand English
- BMI ≥ to 25.
Who cannot join
- Regularly skip meals.
- Are unwilling or unable to limit eating to an 8-hour window.
- Have a current Melanoma or cancer diagnosis.
- Currently breastfeeding.
- Pregnant, or planned to be pregnant within 3 months.
- Are taking insulin or sulfonylurea drugs.
- Are taking weight loss medications or had weight loss surgery within the last year.
- Have a history of eating disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Time Restricted Eating on Obesity: Comparing Windows of Eating to Achieve Weight Loss in Overweight and Obese Adults; a Pilot Study
The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.
- Conditions
- Overweight
- Being tested
- Early time-restricted eating, Late time-restricted eating
- Keywords
- Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early time-restricted eatingBehavioural
Subjects can eat whatever they want between the hours of 8:00 AM and 4:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 4:00 PM to 8:00 AM).
Late time-restricted eatingBehavioural
Subjects can eat whatever they want between the hours of 12:00 PM and 8:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 8:00 PM to noon).
| Study group | Role | What they receive |
|---|---|---|
| Early time-restricted eating | Experimental | Subjects window for eating would be between 08:00 AM - 4:00 PM Receives: Behavioral: Early time-restricted eating |
| Late time-restricted eating | Experimental | Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM Receives: Behavioral: Late time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Reported in kilograms (kg)
Measured: Baseline, 12 weeks
Secondary outcomes (7)
Change in Hemoglobin A1c
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Measured: Baseline, 12 weeks
Change in fasting glucose
Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 12 weeks
Change in total cholesterol
Blood sample taken to measure the sum of blood's cholesterol content and reported in milligrams/deciliter (mg/dL)
Measured: Baseline, 12 weeks
Change in Low-density lipoprotein (LDL) cholesterol
LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Measured: Baseline, 12 weeks
Change in High-density lipoprotein (HDL) cholesterol
HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Measured: Baseline, 12 weeks
Change in Triglycerides
Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)
Measured: Baseline, 12 weeks
Subjects to complete study
Total number of subjects to complete study per protocol
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start24 Feb 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley A. Bohn, Mayo Clinic
- Investigators
- Bradley Bohn, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660291
- Sponsor's protocol ID
- 22-010547
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time Restricted Eating on Obesity: Comparing Windows of Eating to Achieve Weight Loss in Overweight and Obese Adults; a Pilot Study
- ClinicalTrials.gov ID
- NCT05660291
- Acronym / sponsor ID
- 22-010547
- Conditions
- Overweight
- Keywords
- Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Dec 2022 (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 pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early time-restricted eating | Experimental | Behavioral: Early time-restricted eatingSubjects window for eating would be between 08:00 AM - 4:00 PM |
| Late time-restricted eating | Experimental | Behavioral: Late time-restricted eatingSubjects window for eating would be between 12:00 PM (noon) and 8:00 PM |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to read and understand English
- BMI ≥ to 25.
Key exclusion criteria (8 listed)
- Regularly skip meals.
- Are unwilling or unable to limit eating to an 8-hour window.
- Have a current Melanoma or cancer diagnosis.
- Currently breastfeeding.
- Pregnant, or planned to be pregnant within 3 months.
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 |
|---|---|---|
| Early time-restricted eatingSubjects can eat whatever they want between the hours of 8:00 AM and 4:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 4:00 PM to 8:00 AM). | Behavioural | Early time-restricted eating |
| Late time-restricted eatingSubjects can eat whatever they want between the hours of 12:00 PM and 8:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 8:00 PM to noon). | Behavioural | Late time-restricted eating |
Primary outcome
Change in weight
Time frame: Baseline, 12 weeks
Reported in kilograms (kg)
7 secondary outcomes
Change in Hemoglobin A1c
Time frame: Baseline, 12 weeks
Change in fasting glucose
Time frame: Baseline, 12 weeks
Change in total cholesterol
Time frame: Baseline, 12 weeks
Change in Low-density lipoprotein (LDL) cholesterol
Time frame: Baseline, 12 weeks
Change in High-density lipoprotein (HDL) cholesterol
Time frame: Baseline, 12 weeks
Change in Triglycerides
Time frame: Baseline, 12 weeks
Subjects to complete study
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bradley Bohn, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early time-restricted eating and Late time-restricted eating in people with Overweight, run by Mayo Clinic 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in weight (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2025.