Status:
RECRUITING
Effects of a Very Low Carbohydrate Ketogenic Diet or Mediterranean Diet on Markers of Musculoskeletal Health in Older Adults
Lead Sponsor:
University of Florida
Conditions:
Aging
Musculoskeletal Diseases
Eligibility:
All Genders
55-80 years
Phase:
NA
Brief Summary
Preclinical data indicate that very low carbohydrate ketogenic diets (KD) may prevent progression of age-related sarcopenia (skeletal muscle decline) but also may disturb bone metabolism. The investig...
Detailed Description
Eucaloric very low carbohydrate ketogenic diets (KD) are therapeutic diets that mimic fasting by generating ketones for metabolic fuel while meeting nutritional requirements (nutritional ketosis). Nut...
Eligibility Criteria
Inclusion
- Postmenopausal
- BMI 20 to \<40 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 ≤ 2,700 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 fracture risk assessment tool (FRAX) indicates ten year-probability of hip fracture \<3% and ten year-probability of major osteoporotic fracture \<20%
Exclusion
- 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-hypertensive medication
- LDL cholesterol at screening that is elevated (≥ 160 mg/dL) or uncontrolled (≥ 100 mg/dL despise current statin treatment)
- History of recurrent kidney stones
- Current diabetes diagnosis
- Liver disease
- Pancreatic disease
- 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 recall and Mediterranean diet screener
- Participation in concurrent research study
- Currently homeless
- Presence or possibility of co-morbid condition discovered during medical screening that would elicit safety concerns
- Living in skilled nursing facility
- Current gallbladder disease including gallstones
- History of 2 or more abdominal surgeries
- Current chronic constipation
- Current chronic diarrhea
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06203392
Start Date
July 15 2024
End Date
September 30 2026
Last Update
September 9 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610