Comparing the effects of a ketogenic diet and Mediterranean diet on muscle and bone health in older adults
Effects of a Very Low Carbohydrate Ketogenic Diet Versus Mediterranean Diet on Markers of Bone Health and Muscle Function in Older Adults: A Pilot Study
NA · University of Florida · NCT06203392
This study is testing whether a ketogenic diet or a Mediterranean diet can improve muscle and bone health in older adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06203392 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a very low carbohydrate ketogenic diet and a Mediterranean diet on musculoskeletal health markers in older adults. It aims to understand how these diets affect muscle function and bone metabolism, particularly in the context of age-related conditions like sarcopenia. Participants will be randomly assigned to one of the two diets and monitored for changes in their health markers. The findings will help assess the potential benefits and risks of long-term ketogenic diet therapy for older patients.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal adults with a stable weight and specific bone health criteria living within 30 miles of Gainesville, FL.
Not a fit: Patients who are pre- or peri-menopausal, have recent fractures, or significant metabolic bone diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve muscle and bone health in older adults.
How similar studies have performed: While ketogenic diets have shown promise in preclinical studies, this specific comparison with the Mediterranean diet in older adults is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 fracture risk assessment tool (FRAX) indicates ten year-probability of hip fracture \<3% and ten year-probability of major osteoporotic fracture \<20% 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-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 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 recall and Mediterranean diet screener * Currently consume \> 500 mg/day supplemental calcium from all sources or the equivalent of ≥ 2,000 IU/day supplemental vitamin D from all sources or any single oral dose of vitamin D ≥ 14,000 IU on a regular basis * Participation in concurrent research study * Currently homeless
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Cora Best, PhD, RDN — University of Florida
- Study coordinator: Cora Best, PhD, RDN
- Email: corabest@ufl.edu
- Phone: 352-294-3751
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.
Conditions: Aging, Musculoskeletal Diseases, diet, aging, ketogenic, ketosis, Mediterranean