Overweight and Obesity Clinical Trial
Official title:
Effects of Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction on Weight Loss and Metabolic Outcomes in Adults With Obesity
The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are: 1. How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors? 2. How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors? Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction. 1. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support. 2. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.
This is a 52-week randomized, parallel-arm clinical trial designed to assess the effects of early time restricted eating (E-TRE) vs late TRE (L-TRE) vs daily caloric restriction (DCR) within the context of a guidelines-based behavioral weight loss program. 162 adults (age 18-65) with obesity (BMI 27-45 kg/m2) will be recruited from the community and randomized 1:1:1 to E-TRE (eating within an 8-hour window starting 1-2 hours after waking), L-TRE (eating within an 8-hour window starting 5-6 hours after waking) or DCR (caloric restriction of 25% from baseline energy requirements). The primary outcome is change in body weight at 26 weeks. Secondary outcomes include body composition, insulin sensitivity, blood pressure, glucose variability, physical activity, and sleep. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03602001 -
Attentive Eating for Weight Loss
|
N/A | |
Recruiting |
NCT06269159 -
The Power of 24-hour: Co-designing Intervention Components
|
||
Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
Completed |
NCT02996864 -
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
|
N/A | |
Terminated |
NCT03914066 -
A Group-based Treatment of Overweight and Obesity in Primary Care
|
N/A | |
Completed |
NCT04647149 -
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
|
N/A | |
Completed |
NCT03685656 -
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
|
N/A | |
Completed |
NCT05051579 -
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
|
Phase 2 | |
Completed |
NCT04611477 -
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
|
N/A | |
Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
Completed |
NCT03599115 -
Effects of Inhibitory Control Training in Eating Behaviors
|
N/A | |
Recruiting |
NCT05938894 -
Train Your Brain - Executive Function
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Recruiting |
NCT05987306 -
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
|
N/A | |
Completed |
NCT03792685 -
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
|
N/A | |
Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
Completed |
NCT04520256 -
Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
|
Phase 2/Phase 3 | |
Completed |
NCT04979234 -
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
|
N/A |