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
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
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- 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