- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679155
Effect of Early Eating on Body Composition
Effect of Early vs. Late Eating on Body Composition in Young Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Purpose The purpose of the study is to determine the effects of early and late time restricted eating on body composition in overweight and obese young adults. It is hypothesized that early time restricted eating will provide a more desirable effect (lower fat mass) on body composition for the participants.
Sample The sample will include 30 overweight/obese young adults, male and female, ranging in age from 18-30 that volunteer to participate in the study. This sample size is justified assuming a standard deviation of 1.5 based on previous studies and using a power of 80% with the statistical significance of 0.05 the resulting n would be 2(1.5)^2*(0.84+1.96)^2/5=7 (Kadam, P., & Bhalerao, S. (2010). Sample size calculation. International journal of Ayurveda research, 1(1), 55). To account for dropouts/non-interest in participation, 10 participants will be recruited for each group. All individuals must give written informed consent in order to participate in the study. Exclusion criteria include self-reported: diabetes, smoking, CVD, pregnancy, weight loss medication, physical activity level greater than low/sedentary (7500 steps daily), unstable weight (>4kg loss/gain) for 3 months prior to study commencement.
Procedure Inclusion/exclusion criteria will be explicitly stated throughout the recruitment process. Potential participants will be recruited through mass email recruitment via Western email services, presenting one-slide information sessions at the beginning of lectures and posting flyers around campus. Participants will then be in direct contact with Reed Zehr to set up a meeting to gain information of the study. After the information meeting the individuals will be given up to 3 days to determine if they want to participate and give their informed consent. See attached form in the consent section of the ethics application.
Measurement: All participants will be required to have their Body Composition measured using non-invasive densitometry (BodPod). The procedure poses no risk to the participant and takes approximately 5 minutes to complete. This procedure will take place initially one week prior to study commencement and then every 4 weeks after study commencement until the 12 weeks of the study duration are complete. This results in a total of 4 measurements. Upper body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a maximal bench press test. Lower body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a maximal leg press test. Completion of a health-related quality of life questionnaire one week prior to commencement of the study and once again after study completion is also required.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A3K7
- Exercise Nutrition Laboratory, Western University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sedentary- lightly physically active (<7,500 steps daily)
- BMI > 25
- 18-30 yo.
Exclusion Criteria:
- Have diabetes (self-reported)
- Have history of smoking (self-reported)
- Have history of cardiovascular disease (self-reported)
- Have BMI of <24.9
- Are pregnant or become pregnant during the study (self-reported)
- Take medication for weight loss (self-reported)
- Physical activity level > 7500 steps/day
- Unstable weight for 3 months prior to commencement of study (>4kg weight loss/gain)
- Employed in a shift work position
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eTRE
participants allocated to this group will be required to eat only between 0800h and 1600h.
|
early vs late time of day restriction
|
Active Comparator: lTRE
participants allocated to this group will be required to eat only between 1200h and 2000h
|
early vs late time of day restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: <5 mins
|
fat mass vs. fat-free mass via BodPod
|
<5 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
upper body strength test
Time Frame: <10 mins
|
1 rep maximal progressive loading bench press test
|
<10 mins
|
lower body strength test
Time Frame: <10 mins
|
1 rep maximal progressive loading leg press test
|
<10 mins
|
health related quality of life questionnaire
Time Frame: <10 mins
|
subjective feelings of overall health per participant
|
<10 mins
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 117951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on eTRE (Early Time Restricted Eating)
-
Western University, CanadaNot yet recruitingeTRE (Early Time Restricted Eating) With BCAA | eTRE (Early Time Restricted Eating)Canada
-
Western University, CanadaNot yet recruitingeTRE (Early Time Restricted Eating) | eTRE With BISC (Brief Intense Stair Climbing)Canada
-
University of Mississippi, OxfordRecruitingTime Restricted EatingUnited States
-
University of OklahomaCompletedTime Restricted EatingUnited States
-
Western University, CanadaUnknown
-
University of DelawareRecruitingDiet, Healthy | Eating Behavior | Nutrition, Healthy | Time Restricted EatingUnited States
-
University of California, San DiegoSalk Institute for Biological StudiesCompleted
-
Federal University of Rio Grande do SulNot yet recruitingEffects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and ObesityObesity | Overweight and Obesity | Time Restricted Feeding | Intermittent Fasting | Time Restricted Eating
-
Medical University of GdanskActive, not recruitingWellbeing | Mental Health Wellness 1 | Biochemical Markers | Physical Exercise | Time Restricted EatingPoland
-
Children's Hospital Los AngelesRecruitingPediatric Obesity | Time Restricted Feeding | Time Restricted EatingUnited States
Clinical Trials on Eating Time Restriction
-
University of Illinois at ChicagoRecruiting
-
Rutgers, The State University of New JerseyRecruitingWeight Loss | Bone Loss | Time Restricted FeedingUnited States
-
University of Illinois at ChicagoEnrolling by invitation
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting
-
University of Illinois at ChicagoEnrolling by invitation
-
Nanfang Hospital, Southern Medical UniversityNot yet recruiting
-
University of PrimorskaActive, not recruitingHyperglycemia | Inflammation | Hypertension | Metabolic Syndrome | Hypercholesterolemia | Microbial Colonization | Overweight and Obesity | Antioxidative Stress | Time Restricted FeedingSlovenia
-
Idoia LabayenHospital Universitario de NavarraRecruitingObesity | Sarcopenia | Menopause Related Conditions | Osteoporosis PostmenopausalSpain
-
University of Kansas Medical CenterNational Institutes of Health (NIH); American Diabetes AssociationRecruiting
-
Universidad de GranadaUniversidad Pública de NavarraCompletedObesity, Abdominal | Time Restricted Feeding | Cardiometabolic SyndromeSpain