Fasting ENHANCE Pilot Study

Completed · Not applicable

Conditions studied: Overweight and Obesity, Time Restricted Feeding, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT05732935

Run by

University of Florida

People needed

45

Starts

2023-03-13

Expected to finish

2026-05-01

Last updated by the study team

2026-06-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical and Translational Research Building - Institute on Aging Suite — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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