Time-restricted for Aging

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrium Health Wake Forest Baptist Hospital, Winston-Salem, NC
Aging
Time-restricted - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: From Baseline to Month 6, and From Baseline to 9 Months

Month 9
Change in Age-Related Biomarkers-- CRP from serum
Change in Age-Related Biomarkers--Fasting Insulin
Change in Age-Related Biomarkers--cystatin C
Change in Age-Related Biomarkers--interleukin-6 (IL-6)
Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI)
Month 9
Body Weight Change
Month 9
Change in Bone Mineral Density
Change in Energy Intake
Change in Physical Activity Energy Expenditure
Change in Resting Energy Expenditure
Change in Self-Reported Energy Intake
Change in Total Muscle Mass
Changes in Fat
Changes in Lean Body Mass
Physical Function--Change in Grip Strength
Physical Function--Change in Walk Time
Physical Function--Change in eSPPB
Month 9
Change in Cognitive Function--MoCA
Month 9
Degree of sustained CR
Intervention Delivery Costs
Participants with Inter-current Health Events
Retention of study participants
TRE sustainability
Month 12
Community Interest
Recruitment Yields

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Time-Restricted Eating Arm
1 of 3
Remote Caloric Restriction Arm
1 of 3
In-Person Caloric Restriction Arm
1 of 3
Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: Time-restricted · No Placebo Group · N/A

Time-Restricted Eating Arm
Behavioral
Experimental Group · 1 Intervention: Time-restricted · Intervention Types: Behavioral
Remote Caloric Restriction Arm
Behavioral
Experimental Group · 1 Intervention: Remote Caloric Restriction · Intervention Types: Behavioral
In-Person Caloric Restriction Arm
Behavioral
Experimental Group · 1 Intervention: In-Person Caloric Restriction · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to month 6, and from baseline to 9 months
Closest Location: Atrium Health Wake Forest Baptist Hospital · Winston-Salem, NC
N/AFirst Recorded Clinical Trial
1 TrialsResearching Aging
0 CompletedClinical Trials

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,100 Previous Clinical Trials
1,128,905 Total Patients Enrolled
8 Trials studying Aging
4,692 Patients Enrolled for Aging
Barbara J. Nicklas, PhDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
37 Total Patients Enrolled
Michael E. Miller, PhDPrincipal InvestigatorWake Forest University Health Sciences
Stephen B. Kritchevsky, PhDPrincipal InvestigatorWake Forest University Health Sciences
W. Jack Rejeski, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
432 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a resident of Forsyth County, NC or surrounding counties.
You have an indication for weight loss.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.