Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Launched by UNIVERSITY OF MISSISSIPPI, OXFORD · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a method called time-restricted eating (TRE) to see how well it works for people with obesity. In this study, participants will eat their meals within an 8-hour window each day and fast for the remaining 16 hours. The goal is to understand how easy it is to stick to this eating plan, how safe it is, and how it affects things like hunger, weight, and overall health. The study lasts for 9 weeks, which includes one week of preparation before starting the eating plan.

To be eligible for this trial, participants should be between 19 and 65 years old, have a body mass index (BMI) of 25 or higher (indicating obesity), and lead a mostly sedentary lifestyle. They should also have a smartphone and not be following any strict diets. Those with certain health conditions, such as diabetes or heart disease, or those who have recently lost or gained weight significantly, won't be able to participate. If you join the trial, you will be randomly placed in either the TRE group or a control group that doesn’t change their eating schedule. Throughout the study, researchers will check in on how you’re feeling, your eating habits, and any changes in your weight or health. This is a great opportunity to explore a new way of eating while contributing to important research!

Gender

ALL

Eligibility criteria

• 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