The Fuel and Rhythm (FAR) Phase 2 Study

NCT05482711 | Completed DMC

• 2 other identifiers: IRB202102618 -NP30AG028740
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (14)

• Change in Cellular Fuel Utilization

  Fuel preference for mitochondrial energy production of isolated white blood cells (WBC) will be assessed using Agilent/Seahorse technology (XFe96 Flux Analyzer) for high-throughput measurement of mitochondrial oxygen bioenergetic function. We will use the Mito Fuel Flex Test assay (Agilent/Seahorse) to measure basal state mitochondrial fuel oxidation in live cells by using a set of substrates and inhibitors. This assay allows assessing the cell's ability to switch oxidative pathways in meeting basal energetic demands, and the relative contributions of glucose, glutamine and long chain fatty acid oxidation to basal respiration. This is completed by a 12-hour fasting blood draw.

  Assessing change between Baseline and Week 8

• Change in daily blood glucose levels

  A "flash glucose monitor/sensor" (CGM; FreeStyle Libre PRO) will be used to assess the changes in 24-hour blood glucose levels. The FreeStyle Libre sensor is easy to apply and wear and can provide every five-minute glucose data to research monitors for up to 14 days. We will replace the CGM approximately every 2 weeks. In this study, we will use the Freestyle PRO thus the participants will be blinded to the data. We will evaluate pattern changes in daily glycemic excursions by week of the study as well as weekly averages and standard deviation by 6-hour time block.

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene BMAL1

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Bmal1 will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in Heart rate will be assessed by the Oura ring.

  The goal of this development measure is to create a composite measure of circadian health using Wearable Technology (i.e., the Oura ring) that continuously tracks heart rate (beats per minute). The Oura ring is a Bluetooth Smart device and is only active for short periods of time. Data is transmitted continuously when the ring syncs with the app. Additionally, the Bluetooth signal and advertising are turned off when an individual is inactive or sleeping. Participants will be provided with Oura ring and instructed to wear it for the entire course of the study.

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene CLOCK

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of CLOCK will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in body temperature will be assessed by the Oura ring.

  The goal of this development measure is to create a composite measure of circadian health using Wearable Technology (i.e., the Oura ring) that tracks body temperature in Fahrenheit (°F). The Oura ring is a Bluetooth Smart device and is only active for short periods of time. Data is transmitted continuously when the ring syncs with the app. Additionally, the Bluetooth signal and advertising are turned off when an individual is inactive or sleeping. Participants will be provided with Oura ring and instructed to wear it for the entire course of the study.

  Assessing change between Baseline and Week 8

• Change in activity level will be assessed by the Oura ring.

  This development measure aims to create a composite measure of circadian health using Wearable Technology (i.e., the Oura ring) that provides daily activity level scores. The Oura ring is a Bluetooth Smart device and is only active for short periods. Data is transmitted continuously when the ring syncs with the app. Additionally, the Bluetooth signal and advertising are turned off when an individual is inactive or sleeping. Participants will be given an Oura ring and instructed to wear it for the entire course of the study.

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene Nfil2

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Nfil2 will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene Nr1d1

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Nr1d1 will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene Dbp

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Dbp will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene Cry1

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Cry1 will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in circadian rhythm gene Per2

  Whole blood will be collected in Tempus™ Blood RNA Tubes with RNA isolated using the Tempus™ Spin RNA Isolation Kit according to the manufacturer (Applied Biosystems). Relative gene expression of Per2 will be analyzed using quantitative real-time polymerase chain reaction (PCR).

  Assessing change between Baseline and Week 8

• Change in heart rate variability will be assessed by the Oura ring.

  The goal of this development measure is to create a composite measure of circadian health using Wearable Technology (i.e., the Oura ring) that tracks heart rate variability (HRV) in milliseconds (ms). The Oura ring is a Bluetooth Smart device and is only active for short periods. Data is transmitted continuously when the ring syncs with the app. Additionally, the Bluetooth signal and advertising are turned off when an individual is inactive or sleeping. Participants will be provided with Oura ring and instructed to wear it for the entire course of the study.

  Assessing change between Baseline and Week 8

• Change in sleep patterns will be assessed by the Oura ring.

  This development measure aims to create a composite measure of circadian health using Wearable Technology (i.e., the Oura ring) that provides sleep patterns scores. The Oura ring is a Bluetooth Smart device and is only active for short periods. Data is transmitted continuously when the ring syncs with the app. Additionally, the Bluetooth signal and advertising are turned off when an individual is inactive or sleeping. Participants will be provided with an Oura ring and instructed to wear it for the entire course of the study.

  Assessing change between Baseline and Week 8

Secondary Outcomes (10)

• Change in anthropometric measurements

  Assessing change between Baseline and Week 8

• Change in Body Composition

  Assessing change between Baseline and Week 8

• Change in walking speed.

  Assessing change between Baseline and Week 8

• Change in grip strength

  Assessing change between Baseline and Week 8

• Change in Whole Body Fuel Utilization

  Assessing change between Baseline and Week 8

Study Arms (1)

Time Restricted Eating intervention

OTHER

Participants will be asked to stop eating by 7 PM every day and to fast for a target of 16 hours per day for 8 weeks. During the first two weeks of the intervention, participants will gradually ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 8 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Additionally, they will be asked to keep a Fasting and Sleeping diary logging their eating habits and sleep quality.

Other: Time Restricted Eating Intervention

Interventions

Time Restricted Eating Intervention OTHER

All participants will be asked to adhere to suggested fasting and feeding periods throughout the 8 week study period. These participants will self-monitor eating and sleeping habits as well to present to study staff at checkpoints. Self-reported information will be used during group-mediated intervention sessions throughout the duration of the study, as well.

Time Restricted Eating intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (35)

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Study Officials

• Stephen Anton, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 1, 2022
• Study Start: January 10, 2023
• Primary Completion: August 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2025
• Access Criteria: Professor at an Accredited University

Locations

US (1)