Testing time restricted eating for improving cognitive function in older adults
Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement (FASTING ENHANCE)
This study is testing if a daily 16-hour fasting plan can help improve thinking skills and overall well-being in older adults who are overweight and at risk for memory problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05732935 on ClinicalTrials.gov |
What this trial studies
The Fasting ENHANCE study aims to evaluate the effects of a time restricted eating (TRE) regimen on cognitive function and overall well-being in overweight older adults at risk for cognitive decline. Participants aged 65 and older will be assigned to either a TRE intervention, where they will fast for 16 hours daily, or a successful aging comparison group for 24 weeks. The study will assess improvements in cognitive and physical function, sleep quality, mood, and quality of life. This approach is grounded in geroscience, focusing on the relationship between metabolic health and cognitive aging.
Who should consider this trial
Good fit: Ideal candidates are overweight adults aged 65 and older who have experienced cognitive difficulties and are at risk for cognitive decline.
Not a fit: Patients with recent cardiovascular disease, diabetes, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to enhance cognitive function and quality of life in older adults at risk for cognitive decline.
How similar studies have performed: Other studies have shown promising results with time restricted eating in improving metabolic health, but this specific application in older adults at risk for cognitive decline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- Clinical and Translational Research Building - Institute on Aging Suite — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Anton, Ph.D. — University of Florida
- Study coordinator: Stephen Anton, Ph.D.
- Email: santon@ufl.edu
- Phone: 352-273-7514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.