Time Restricted EatingNCT06695988
Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
A study testing Time Restricted Eating in people with Time Restricted Eating and Obesity, run by University of Mississippi, Oxford at 1 site in United States.
Trial summary
A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Eating, Obesity
- 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 28 Aug 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19 to 65 years
- Owns a smartphone
- Apparently healthy
- BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively)
- Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week)
- Self-reported eating interval of ≥12 h per day
Who cannot join
- Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
- Currently taking any medication that is meant for, or has a known effect on, appetite
- On anabolic steroid or hormone replacement therapy
- Participation in an exercise/nutrition/ weight-loss program within the last 6 months
- Any history of surgical intervention for weight management
- Having a ≥5% body weight change during the last 3 months
Show all 16Show fewer
- Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
- missing limbs, have a pacemaker or metal implants,
- eating disorders or EAT-26 score >20
- Alcohol or drug addiction
- Current smoker
- Works night shifts
- Unable to commit to a 9-week study
- Not willing to follow study protocol and any other contraindications.
- Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet
- Participating in another study
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutrition and Hospitality Management, University of Mississippi
Oxford, Mississippi, 38677
About this study
Official title: Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.
- Conditions
- Time Restricted Eating, Obesity
- Being tested
- Time Restricted Eating
- Keywords
- Time Restricted Eating, Obesity, Intervention, 9 weeks, Randomization, Intermittent fasting
- Medical subject headings
- Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
The intervention group will eat and drink in a prescribed daily feeding window of 8-hour between 6 a.m. to 8 p.m. for 8 weeks and follow their normal exercise and resistance training routines. We will allow +/-1 hour starting and ending times for the eating window while aiming for an 8-hour eating window
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating Group | Experimental | The TRE group will consume calorie-containing food and drinks only over an 8-hour window between 6 a.m. to 8 p.m. for 8 weeks. During the fasting period, they can take only calorie-free fluids. Receives: Behavioral: Time Restricted Eating |
| Control | No intervention | They will follow their usual eating patterns and consume food over a period of 12 hours or more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily.
Measured: 8 weeks
Total calorie intake
Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software.
Measured: During baseline week and week 8 of the intervention
Secondary outcomes (14)
Body weight (kg)
Pre and post intervention measures of body weight.
Measured: At baseline and at the end of 8 weeks of intervention
24-hour physical activity energy expenditure (PAEE)
GT9X Actigraph accelerometer will be used over 7 days to measure physical activity energy expenditure pre-intervention and during week 8 of the intervention.
Measured: During baseline week and week 8 of the intervention
Body fat percentage (%)
Pre and post intervention measurements of body fat percentage measured by bioelectrical impedance analyzer.
Measured: At baseline and at the end of 8 weeks of intervention
Fat-free mass (kg)
Pre and post intervention measurements of body fat-free mass (kg) measured by bioelectrical impedance analyzer.
Measured: At baseline and at the end of 8 weeks of intervention
Fat mass (kg)
Pre and post intervention measurements of body fat mass (kg) measured by bioelectrical impedance analyzer.
Measured: At baseline and at the end of 8 weeks of intervention
Hunger and satiety
Pre and post intervention subjective measure of hunger and satiety with the use of a Hunger and Satiety Visual Analog Scale
Measured: During baseline week and week 8 of the intervention
Sleep quality
Pre and post intervention measure of subjective sleep quality by use of Pittsburgh Sleep Quality Scale.
Measured: One time during the baseline week and week 8 of the intervention
Diet Quality
Pre and post intervention measurements of diet quality based on three 24-hour food recall surveys at pre- and post collected using the NDSR software and Healthy Eating Index was calculated.
Measured: During baseline week and week 8 of the intervention
Perceptions of health and well-being
Pre- and post quality of life will be assessed using RAND 36-Item Health Survey 1.0 (SF-36)
Measured: At baseline and at the end of 8 weeks of intervention
Weight Bias Internalization
Pre- and post weight bias internalization will be assessed using the Weight Bias Internalization Scale (WBIS).
Measured: At baseline and at the end of 8 weeks of intervention
Disordered eating risk
Pre- and post disordered eating risk will be assessed using Eating Attitude Test (EAT-26) survey scores
Measured: At baseline and at the end of 8 weeks of intervention
Eating Behavior
Pre and post eating behavior will be assessed using the Three Factor Eating Questionnaire (TFEQ-18). The TFEQ-R18 measures 3 aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating
Measured: At baseline and at the end of 8 weeks of intervention
Skin carotenoid
Pre- and post skin carotenoid levels will be measured pre and post-intervention using a non-invasive NuSkin Biophotonic scanner which is based on the Resonant Raman Spectroscopy technology.
Measured: At baseline and at the end of 8 weeks of intervention
Motivators, barriers, and facilitators for following time restricted eating
Motivators, barriers, and facilitators when following time restricted eating will be assessed only in the TRE group. These will be collected as qualitative data in the format of a semi-structured interviews over Zoom.
Measured: At end of 2nd week and during the 8th week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Jun 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi, Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadeeja Wijayatunga, University of Mississippi, Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695988
- Sponsor's protocol ID
- 24-033FB
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2024
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
- ClinicalTrials.gov ID
- NCT06695988
- Acronym / sponsor ID
- 24-033FB
- Conditions
- Time Restricted Eating, Obesity
- Keywords
- Time Restricted Eating, Obesity, Intervention, 9 weeks, Randomization, Intermittent fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Mississippi, OxfordUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 19 Nov 2024 (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.
A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating Group | Experimental | Behavioral: Time Restricted EatingThe TRE group will consume calorie-containing food and drinks only over an 8-hour window between 6 a.m. to 8 p.m. for 8 weeks. During the fasting period, they can take only calorie-free fluids. |
| Control | No intervention | –They will follow their usual eating patterns and consume food over a period of 12 hours or more. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19 to 65 years
- Owns a smartphone
- Apparently healthy
- BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively)
- Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week)
Key exclusion criteria (16 listed)
- Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
- Currently taking any medication that is meant for, or has a known effect on, appetite
- On anabolic steroid or hormone replacement therapy
- Participation in an exercise/nutrition/ weight-loss program within the last 6 months
- Any history of surgical intervention for weight management
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 EatingThe intervention group will eat and drink in a prescribed daily feeding window of 8-hour between 6 a.m. to 8 p.m. for 8 weeks and follow their normal exercise and resistance training routines. We will allow +/-1 hour starting and ending times for the eating window while aiming for an 8-hour eating window | Behavioural | Time Restricted Eating Group |
Primary outcome
Adherence
Time frame: 8 weeks
Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily.
Total calorie intake
Time frame: During baseline week and week 8 of the intervention
Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software.
14 secondary outcomes
Body weight (kg)
Time frame: At baseline and at the end of 8 weeks of intervention
24-hour physical activity energy expenditure (PAEE)
Time frame: During baseline week and week 8 of the intervention
Body fat percentage (%)
Time frame: At baseline and at the end of 8 weeks of intervention
Fat-free mass (kg)
Time frame: At baseline and at the end of 8 weeks of intervention
Fat mass (kg)
Time frame: At baseline and at the end of 8 weeks of intervention
Hunger and satiety
Time frame: During baseline week and week 8 of the intervention
Sleep quality
Time frame: One time during the baseline week and week 8 of the intervention
Diet Quality
Time frame: During baseline week and week 8 of the intervention
Perceptions of health and well-being
Time frame: At baseline and at the end of 8 weeks of intervention
Weight Bias Internalization
Time frame: At baseline and at the end of 8 weeks of intervention
Disordered eating risk
Time frame: At baseline and at the end of 8 weeks of intervention
Eating Behavior
Time frame: At baseline and at the end of 8 weeks of intervention
Skin carotenoid
Time frame: At baseline and at the end of 8 weeks of intervention
Motivators, barriers, and facilitators for following time restricted eating
Time frame: At end of 2nd week and during the 8th week of intervention.
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 19 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity, run by University of Mississippi, Oxford 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 6 inclusion and 16 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 19 Oct 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?
Adherence (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 19 Oct 2026.