Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Time Restricted Eating
  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

Первичные конечные точки

• Adherence [Срок оценки: 8 weeks]
• Total calorie intake [Срок оценки: During baseline week and week 8 of the intervention]

Вторичные конечные точки (12)

• Body weight (kg) [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• 24-hour physical activity energy expenditure (PAEE) [Срок оценки: During baseline week and week 8 of the intervention]
• Body fat percentage (%) [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Fat-free mass (kg) [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Fat mass (kg) [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Hunger and satiety [Срок оценки: During baseline week and week 8 of the intervention]
• Sleep quality [Срок оценки: One time during the baseline week and week 8 of the intervention]
• Diet Quality [Срок оценки: During baseline week and week 8 of the intervention]
• Perceptions of health and well-being [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Weight Bias Internalization [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Disordered eating risk [Срок оценки: At baseline and at the end of 8 weeks of intervention]
• Eating Behavior [Срок оценки: At baseline and at the end of 8 weeks of intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Department of Nutrition and Hospitality Management, University of Mississippi — Oxford

Идентификаторы

NCT: NCT06695988 · UMississippiO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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