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Sponsor: University of Florida
Conditions: Overweight and Obesity, Time Restricted Feeding, Alzheimer Disease
Interventions: Time Restricted Eating intervention, Successful Aging Comparison Group (LEARN)
Countries: United States
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.
Sex: ALL
Age: 65 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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.
- Gainesville, Florida, United States