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

Description

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 investigators will pilot test a randomized trial comparing the effects of short-term adaptation to a well-formulated ketogenic diet and Mediterranean diet on markers of bone metabolism and muscle function in older adults. The expected results will help inform the benefit-risk assessment for older patients considering longer term use of KD therapy.

Conditions

Aging, Musculoskeletal Diseases

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Study Overview

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Study Details

Study overview

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 investigators will pilot test a randomized trial comparing the effects of short-term adaptation to a well-formulated ketogenic diet and Mediterranean diet on markers of bone metabolism and muscle function in older adults. The expected results will help inform the benefit-risk assessment for older patients considering longer term use of KD therapy.

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

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

Condition
Aging
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Florida,

Cora Best, PhD, RDN, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2026-04