Fasting ENHANCE Pilot Study

September 6, 2023 updated by: University of Florida

Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement (FASTING ENHANCE)

Grounded in the principles of geroscience, the proposed Fasting ENHANCE study will test whether a time restricted eating (TRE) regimen can improve cognitive function and other aspects of successful aging in a safe and sustainable manner in at risk overweight older adults. Specifically, this study will evaluate whether TRE can improve cognitive and physical function, as well as self-reported sleep, mood, and quality of life, in overweight, older adults (age > 65 years) who are at high risk of cognitive decline due to self-reported cognitive difficulties. Eligible participants will be assigned to either a TRE intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the past century, persons aged >70 years represented the fastest growing segment of the US population with the life expectancy of older Americans steadily increasing, until the onset of COVID-19 in 2020. Unfortunately, the increase in lifespan has not been accompanied by an increase in health-span, which is the time-period in which a person is healthy and functionally independent. Rather, the aging population has been accompanied by an increase in the number of individuals living with chronic metabolic and neurocognitive disease conditions, including obesity, metabolic syndrome, and Alzheimer's disease and Related Disorders (ADRD). Moreover, poor metabolic health appears to be a risk factor for accelerated brain aging; therefore improving metabolic health may represent a strategy to improve long-term brain health.

Although age-related biological and metabolic changes clearly have a role in the development of chronic health conditions and risk for ADRD, a growing body of research indicates lifestyle factors contribute to modifiable patho-physiological states that precede the development of many age-related chronic health conditions. Specifically, over-nutrition, sedentary lifestyle, and poor sleep habits have been directly linked with metabolic diseases, as well as cognitive decline and development of ADRD in later life.

Our work and that of others has demonstrated that the rate of functional decline among older adults is highly influenced by biological and metabolic changes during aging, which are largely affected by lifestyle factors, namely dietary intake, sleep, and physical activity levels. Specifically, the investigators have shown that intermittent fasting (IF) regimens, particularly time restricted eating (TRE), can have positive effects on biological, metabolic, and functional health markers in middle-aged and older adults, similar to that of calorie restriction. These observations raise the possibility that interventions targeting the fundamental biology of human aging have the potential to delay, if not prevent, the onset of aging-associated conditions, such as ADRD. The unprecedented growth of the aging population has created an urgent need for promising interventions that can preserve older adult's capacity to live independently and function well.

The scientific premise of this proposal is that a time-restricted eating intervention can target the cellular and metabolic alterations that underlie age-related metabolic and neurocognitive disease conditions and thereby extend health-span in the growing population of older adults who reported subjective cognitive decline.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephen Anton, Ph.D.
  • Phone Number: 352-273-7514
  • Email: santon@ufl.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32603
        • Recruiting
        • Clinical and Translational Research Building - Institute on Aging Suite
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Anton, PhD

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.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 65 years;
  • Body Mass Index (BMI > 25 kg/m2)
  • Normal age-, gender-, and education-adjusted performance on TICS-M (Telephone Interview for Cognitive Status)
  • Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive Decline Questionnaire
  • Reports onset of cognitive difficulties in past five years
  • Reports they believe they are worse than others their age OR they have talked to a clinician about it.
  • Provides informed consent and willing to be randomized to either intervention group.

Exclusion Criteria:

  • Failure to provide informed consent;
  • Recent History or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
  • Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal) as determined by study physician.
  • Significant cognitive impairment, defined as a scores below the cutoff for dementia on TICS-M
  • Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease);
  • Terminal illness with life expectancy less than 12 months, as determined by a physician;
  • Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia);
  • Current use of anabolic medications (i.e., growth hormones or testosterone), antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept), anticoagulant therapies (aspirin use is permitted), or antibiotics;
  • Excessive alcohol use (>14 drinks per week);
  • History of drug or alcohol abuse (i.e., more than 5 drinks/day for males or more than 4 drinks/day for females);
  • Planning to permanently leave the area in the next year;
  • History of pulmonary disease, pneumonitis or interstitial lung disease;
  • Current smoker or less than 3 years quit;
  • Creatinine clearance < 30 ml/minute by estimated Glomerular Filtration Rate (eGFR);
  • Fasting >12 hours per day
  • Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake or weight loss > 5 lbs in the past month
  • Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg 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
  • Insulin dependent diabetes mellitus
  • Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
  • Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment
  • Any condition that in the opinion of the investigator would impair ability to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time Restricted Eating intervention
In the time restricted eating condition, participants will be instructed to fast for a target of 16 hours per day for a 24 week period.
Behavioral: Time Restricted Eating intervention

In the TRE intervention, participants will be asked to fast for a target of 16 hours per day for a period of 24 weeks. The first few weeks will involve of a 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 - 16 - 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. Participants will be asked to record the time of first and final food/drink consumption each day.

Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

Other Names:
  • TRE intervention
Active Comparator: Successful Aging Comparison Group (LEARN)
In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks.
Behavioral: Successful Aging Comparison Group (LEARN)

In the Successful Aging Comparison Group (LEARN), participants will attend lectures on topic relevant to healthy aging at the same frequency as the group meetings in the TRE intervention.

Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatable Battery of the Assessment of Neuropsychological Status (RBANS)
Time Frame: Baseline up to Week 24
The RBANS is a neuropsychological battery of tests that has 4 repeatable forms that can be used longitudinally to measure cognitive change. It takes 30 minutes to administer and includes measures of five cognitive domains including immediate memory, visuospatial/constructional, language, attention, and delayed memory. This test is reliable in yielding results that recognize cognitive impairment associated with neurodegenerative disease. The RBANS can be used in predicting cognitive impairment with particular emphasis on the language and immediate memory subtests.
Baseline up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline up to Week 24
The Montreal Cognitive Assessment is a 30-point assessment of mild cognitive impairment, which assesses the domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Different versions of the test are given at the three time points to avoid learning effects between repeated administrations of the test.
Baseline up to Week 24
6 Minute Walk Test
Time Frame: Baseline up to Week 24
The 6 Minute Walk test measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. It has been found to be a valid and reliable measure of physical function in numerous studies.
Baseline up to Week 24
Short Physical Performance Battery (SPPB)
Time Frame: Baseline up to Week 24
The SPPB will also be used to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.
Baseline up to Week 24
Grip Strength
Time Frame: 1st Day of Screening
Isometric grip strength, a commonly used measure of upper body skeletal function, will be assessed with a hand held dynamometer
1st Day of Screening
Pittsburgh Sleep Quality Index
Time Frame: Baseline up to Week 24
Sleep will be assessed by the Pittsburgh Sleep Quality Index, a self-report tool which consists of 19-item scale that provides seven component scores (ranges 0-3): (a) subjective sleep quality (very good to very bad), (b) sleep latency (≤15 to >60 minutes), (c) sleep duration (≥7 to <5 hours), (d) sleep efficiency (≥85% to <65% hours sleep/ hours in bed), (e) sleep disturbances (not during the past month to ≥3 times per week), (f) use of sleeping medications (none to ≥3 times a week), and (g) daytime dysfunction (not a problem to a very big problem) with a total global score ranging from 0 to 21.
Baseline up to Week 24
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time Frame: Baseline up to Week 24
The State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) was designed to assess cognitive and somatic symptoms of anxiety as they pertain to one's mood in the moment (state) and in general (trait). This measure has been validated in a sample of older adults.
Baseline up to Week 24
Geriatric Depression Scale
Time Frame: Baseline up to Week 24
Symptoms of depression will be assessed by the Geriatric Depression Scale, a self-report questionnaire to measure depression in older adults.
Baseline up to Week 24
Short Form (SF) -12 Health Survey
Time Frame: Baseline up to Week 24
This 12-item short form questionnaire assesses both mental and physical components of health-related quality of life. The SF-12 Health Survey assesses 8 general domains: physical activity limitation due to health problems, social activity limitation due to physical/emotional problems, daily role activity limitations due to physical health problems, body pain, general mental health, daily role activity limitation due to emotional problems, energy and fatigue, and general health perceptions.
Baseline up to Week 24
Pittsburgh Fatiguability Scale
Time Frame: Baseline up to Week 24
The 26-item Pittsburgh Fatiguability Scale will be administered to measure perceived mental and physical fatigability. Questions are divided into 4 main categories: moderate to high-intensity activity (≥3.0 metabolic equivalents (METS), social activity, sedentary activity (≤1.5 METS), and lifestyle or light-intensity activity (1.6-2.9 METS). Higher scores suggest higher levels of perceived fatigability.
Baseline up to Week 24
Anthropometric Measurements.
Time Frame: 1st Day of Screening up to Week 24
Body weight will be measured following the removal of excess clothing and shoes with calibrated scales. Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
1st Day of Screening up to Week 24
Metabolic and Systemic biomarkers
Time Frame: Baseline up to Week 24
Biomarkers of glucose regulation (HbA1C), systemic inflammation (C-reactive protein), and neurodegenerative diseases, Tau will be assessed. Samples will be measured in duplicate and the average of the two measures will be used for data analyses.
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program

Investigators

  • Principal Investigator: Stephen Anton, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202202838
  • R21AG081667 (Other Identifier: UF)
  • PRO00048080 (Other Identifier: UFIRST)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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