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Fasting ENHANCE Pilot Study
Fasting ENHANCE Pilot Study

NCT05732935

CompletedNA

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.

Eligibility overview

Sex: ALL

Age: 65 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Gainesville, Florida, United States