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NCT Number: NCT06695988

Time-restricted Eating Acceptability, Efficacy and Safety in 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.

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Key information

Conditions

Time Restricted Eating Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Hospitality Management, University of Mississippi

Oxford, Mississippi, 38677, United States

Location status: Recruiting

Location contact

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN

CONTACT

[email protected]

662 915 1351

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Time restricted eating

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Body weight (kg)

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre and post intervention measures of body weight.

  2. 24-hour physical activity energy expenditure (PAEE)

    Time frame: During baseline week and week 8 of the intervention

    GT9X Actigraph accelerometer will be used over 7 days to measure physical activity energy expenditure pre-intervention and during week 8 of the intervention.

  3. Body fat percentage (%)

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre and post intervention measurements of body fat percentage measured by bioelectrical impedance analyzer.

  4. Fat-free mass (kg)

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre and post intervention measurements of body fat-free mass (kg) measured by bioelectrical impedance analyzer.

  5. Fat mass (kg)

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre and post intervention measurements of body fat mass (kg) measured by bioelectrical impedance analyzer.

  6. Hunger and satiety

    Time frame: During baseline week and week 8 of the intervention

    Pre and post intervention subjective measure of hunger and satiety with the use of a Hunger and Satiety Visual Analog Scale

  7. Sleep quality

    Time frame: One time during the baseline week and week 8 of the intervention

    Pre and post intervention measure of subjective sleep quality by use of Pittsburgh Sleep Quality Scale.

  8. Diet Quality

    Time frame: During baseline week and week 8 of the intervention

    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.

  9. Perceptions of health and well-being

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre- and post quality of life will be assessed using RAND 36-Item Health Survey 1.0 (SF-36)

  10. Weight Bias Internalization

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre- and post weight bias internalization will be assessed using the Weight Bias Internalization Scale (WBIS).

  11. Disordered eating risk

    Time frame: At baseline and at the end of 8 weeks of intervention

    Pre- and post disordered eating risk will be assessed using Eating Attitude Test (EAT-26) survey scores

  12. Eating Behavior

    Time frame: At baseline and at the end of 8 weeks of intervention

    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

  13. Skin carotenoid

    Time frame: At baseline and at the end of 8 weeks of intervention

    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.

  14. Motivators, barriers, and facilitators for following time restricted eating

    Time frame: At end of 2nd week and during the 8th week of intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN

CONTACT

[email protected]

662 915 1351

Sponsors and collaborators

Lead sponsor

University of Mississippi, Oxford

Other

Registry information

Official study title

Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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