NCT05486702

Brief Summary

The purpose of the study is to determine if body composition differs between early time restricted eating (8-hour feeding period from 7 am to 3 pm) with exercise and late time restricted eating (8-hour feeding period from 3 pm to 11 pm) with exercise in overweight adults.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

June 22, 2022

Last Update Submit

August 2, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10

    The DXA is a validated instrument, assessing fat, soft tissue, and bone mass.

    Baseline and Week 10

Study Arms (2)

Early Time Restricted Eating

EXPERIMENTAL

8-hour eating period from 7 am to 3 pm with exercise

Other: Time Restricted Eating

Late Time Restricted Eating

EXPERIMENTAL

8-hour eating period from 3 pm to 11 pm with exercise

Other: Time Restricted Eating

Interventions

Time Restricted EatingOTHER

Time restricted eating (TRE) can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window.

Early Time Restricted EatingLate Time Restricted Eating

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • are adults, aged between 18-30 years
  • are apparently healthy and physically inactive (defined as any form of physical activity performed \< 2 days per week)
  • are overweight (BMI 25-\<30 kg/m2)
  • are non-smokers
  • are free from the following chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV)
  • are free from the orthopedic conditions that would hinder physical activity
  • have not taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinological (e.g, thyroid, insulin, etc), emotional/psychotropic (e.g,Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications(anabolic steroids)
  • have low risk for cardiovascular disease and with no contraindications to exercise as outlined by the American College of Sports Medicine (ACSM) will be included.

You may not qualify if:

  • are younger than 18 years and older than 30 years.
  • have consumed any medication for chronic medical condition.
  • are participating in weight management programs.
  • have constrictions to exercise.
  • are currently exercising regularly (at least 2 days per week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Exercise Science Laboratory

Milledgeville, Georgia, 31061, United States

RECRUITING

Clinical Research Laboratory

Syracuse, New York, 13244, United States

RECRUITING

Anatomical Laboratory

Wichita Falls, Texas, 76308, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jinkyung Park, Dr.

    Georgia College and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinkyung Park, Dr.

CONTACT

478-445-3930jinkyung.park@gcsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 22, 2022

First Posted

August 3, 2022

Study Start

August 1, 2022

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)