ACTIVE_NOT_RECRUITING

Fasting ENHANCE Pilot Study

Conditions

Overweight and Obesity Time Restricted Feeding Alzheimer Disease Aging Time Restricted Eating Overweight Obesity Alzheimer's Disease and Related Disorders (ADRD)

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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

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.

Official Title

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

Quick Facts

Study Start:2023-03-13

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05732935

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
* 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Stephen Anton, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

Clinical and Translational Research Building - Institute on Aging Suite

Gainesville, Florida, 32603

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 Date2023-03-13

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-03-13

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Aging
Time Restricted Eating
Overweight
Obesity
Alzheimer's Disease and Related Disorders (ADRD)

Additional Relevant MeSH Terms

Overweight and Obesity
Time Restricted Feeding
Alzheimer Disease