Effects of a Very Low Carbohydrate Ketogenic Diet or Mediterranean Diet on Markers of Musculoskeletal Health in Older Adults

Launched by UNIVERSITY OF FLORIDA · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different diets—the very low carbohydrate ketogenic diet and the Mediterranean diet—affect muscle and bone health in older adults. Researchers want to learn if these diets can help maintain muscle strength and bone health, which are important as we age. They are looking for postmenopausal men and women aged 21 years and older who are stable in weight and willing to follow specific dietary instructions. Participants should live within 30 miles of Gainesville, FL, and own a smartphone.

If you join the study, you will be provided with meals that fit the assigned diet and asked to keep track of what you eat. You’ll also need to attend visits to the study site. The trial aims to see how these diets may benefit older adults regarding their muscle and bone health, which could help doctors and patients make better decisions about long-term diet choices. It's important to note that there are specific health conditions that might disqualify someone from participating, like certain chronic diseases or dietary restrictions.

Gender

ALL

Eligibility 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