Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
Time Restricted Eating intervention
Successful Aging Comparison Group (LEARN)
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 65 years;
Body Mass Index (BMI > 25 kg/m2)
Normal age-, gender-, and education-adjusted performance on TICS-M (TelephoneInterview for Cognitive Status)
Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive DeclineQuestionnaire
Reports onset of cognitive difficulties in past five years
Reports they believe they are worse than others their age OR they have talked to aclinician about it.
Provides informed consent and willing to be randomized to either intervention group.
Exclusion
Exclusion Criteria:
Failure to provide informed consent;
Recent History or clinical manifestation of cardiovascular disease, diabetes,cholelithiasis, liver or renal disease, cancer, or progressive, degenerativeneurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassiumlevels, or hemoglobin and hematocrit below the lower limit of normal) as determinedby study physician.
Significant cognitive impairment, defined as a scores below the cutoff for dementiaon 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 aphysician;
Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severepsychiatric 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 useis 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 morethan 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 orsignificantly 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 ordiastolic 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 orheart 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 foodat least 12 hours apart)
Participating in another clinical trial or has received an investigational productwithin 30 days prior to screening/enrollment
Any condition that in the opinion of the investigator would impair ability toparticipate in the trial.
Study Design
Study Description
Connect with a study center
Clinical and Translational Research Building - Institute on Aging Suite
Gainesville, Florida 32603
United StatesSite Not Available
Clinical and Translational Research Building - Institute on Aging Suite
Gainesville 4156404, Florida 4155751 32603
United StatesSite Not Available

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