ACTIVE_NOT_RECRUITING

The Fuel and Rhythm (FAR) Phase 2 Study

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Both fuel metabolism and circadian rhythms have emerged as important targets to improve cellular and mitochondrial health and ultimately affect function in older adults. Thus, the purpose of this study is to develop minimally invasive measures that will allow us to accurately assess and detect changes in fuel metabolism and circadian rhythms in older adults following time-restricted eating.

Official Title

Assessment of Fuel Utilization and Circadian Rhythms in Overweight, Older Adults Following Time Restricted Eating - Phase 2 (FAR Phase 2)

Quick Facts

Study Start:2023-01-10

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05482711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Consent to participate in the study * Men and women ≥ 65 years old * Self-reported difficulty walking ¼ mile or climbing a flight of stairs * Self-reported sedentariness (\<150 minutes structured exercise per week) * Walking speed \<1 m/sec on the 4 m walk test * Able to walk unassisted (cane allowed) * Have a body mass index between 25 - 40 kg/m2 (inclusive) * HbA1c \< 5.7 %	* Fasting \>12 hours per day * Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake * Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure of \> 100 mmHg * Unstable angina, heart attack or stroke in the past 3 months * Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure * Rheumatoid arthritis, Parkinson's disease or currently on dialysis * Active treatment for cancer in the past year * Diabetes Mellitus * Known history of skin sensitivity or allergic reaction to adhesives * Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart) * Any condition that in the opinion of the investigator would impair ability to participate in the trial

Inclusion Criteria

Exclusion Criteria

* Consent to participate in the study
* Men and women ≥ 65 years old
* Self-reported difficulty walking ¼ mile or climbing a flight of stairs
* Self-reported sedentariness (\<150 minutes structured exercise per week)
* Walking speed \<1 m/sec on the 4 m walk test
* Able to walk unassisted (cane allowed)
* Have a body mass index between 25 - 40 kg/m2 (inclusive)
* HbA1c \< 5.7 %

* Fasting \>12 hours per day
* Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
* Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure of \> 100 mmHg
* Unstable angina, heart attack or stroke in the past 3 months
* Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
* Rheumatoid arthritis, Parkinson's disease or currently on dialysis
* Active treatment for cancer in the past year
* Diabetes Mellitus
* Known history of skin sensitivity or allergic reaction to adhesives
* Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
* Any condition that in the opinion of the investigator would impair ability to participate in the trial

Contacts and Locations

Principal Investigator

Stephen Anton, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Stephen Anton, Ph.D., PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-01-10

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Aging