Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
ConditionTime Restricted Eating
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorUniversity of Mississippi, Oxford
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Time Restricted Eating
BehavioralThe 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
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Time Restricted Eating GroupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Adherence
Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily.
Time frame
8 weeks2
Total calorie intake
Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software.
Time frame
During baseline week and week 8 of the interventionSecondary outcomes
1
Body weight (kg)
Pre and post intervention measures of body weight.
Time frame
At baseline and at the end of 8 weeks of intervention2
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.
Time frame
During baseline week and week 8 of the intervention3
Body fat percentage (%)
Pre and post intervention measurements of body fat percentage measured by bioelectrical impedance analyzer.
Time frame
At baseline and at the end of 8 weeks of intervention4
Fat-free mass (kg)
Pre and post intervention measurements of body fat-free mass (kg) measured by bioelectrical impedance analyzer.
Time frame
At baseline and at the end of 8 weeks of interventionSponsors and contacts
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Source ClinicalTrials.gov