Phase
Condition
Musculoskeletal Diseases
Aging
Treatment
Very low carbohydrate ketogenic diet
Mediterranean diet
Clinical Study ID
Ages > 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Postmenopausal
BMI 20 to <35 kg/m2
Weight stable for last 12 months
Male or female biological sex
Willing to eat supplied food and adhere to dietary advice
Willing to document food intake
Willing to maintain weight
Willing to attend study visits
Smartphone ownership
Community-dwelling with permanent living arrangement
Resides within 30 miles of Gainesville, FL
Willing to avoid alcohol intake
Estimated energy requirement ≤ 2,600 kcal/day
Have a refrigerator and means to reheat food within dwelling
Bone mineral density tested within past 5 years or U.S. ethnicity-specific fracturerisk assessment tool (FRAX) indicates ten year-probability of hip fracture <3% andten year-probability of major osteoporotic fracture <20%
Exclusion
Exclusion Criteria:
Pre- or peri-menopausal
Fracture in past 6 months
Circulating 25-hydroxyvitamin D < 20 ng/mL at screening
History or prevalence of metabolic bone disease
Chronic kidney disease diagnosis or eGFR <60 mL/min/1.73 m2 at screening
Current or history of cancer excluding non-melanoma skin cancer
Clinical cardiovascular disease, excluding current use of anti-hypertensivemedication
LDL cholesterol at screening that is elevated (≥ 160 mg/dL) or uncontrolled (≥ 100mg/dL despise current statin treatment)
History of recurrent kidney stones
Current diabetes diagnosis or hemoglobin A1C ≥ 6.5% at screening.
Liver disease
Pancreatic disease
Alcoholism diagnosis or heavy drinking per CDC definition
Currently smoke tobacco
Malabsorption disease including celiac and inflammatory bowel disease
Inborn error of metabolism including disorders of fatty acid transport or oxidation,organic aciduria, porphyria, or familial hyperlipidemia
Dementia diagnosis
Dietary restrictions including food allergy, vegetarianism, veganism or gluten,dairy, or seafood avoidance
Current or history of diagnosed eating disorder
Thyroid disorder
Male hypogonadism
Menopause before age 40 years
Gender-affirming hormone therapy
Currently eat a ketogenic or Mediterranean diet based on ASA 24-hour dietary recalland Mediterranean diet screener
Currently consume > 500 mg/day supplemental calcium from all sources or theequivalent of ≥ 2,000 IU/day supplemental vitamin D from all sources or any singleoral dose of vitamin D ≥ 14,000 IU on a regular basis
Participation in concurrent research study
Currently homeless
Study Design
Study Description
Connect with a study center
University of Florida
Gainesville, Florida 32610
United StatesActive - Recruiting
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