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

NCT06203392 | Completed DMC

• 2 other identifiers: IRB2023013292P30AG028740-16
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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

Keywords

diet, aging, ketogenic, ketosis, Mediterranean

Outcome Measures

Primary Outcomes (3)

• Rate of enrollment

  Number of participants enrolled in dietary intervention phase per month

  Monthly. Up to 24 months.

• Screen failure rate (percentage)

  Number of participants deemed ineligible / number of participants screened \* 100

  Monthly. Up to 24 months.

• Treatment-specific retention rates

  Percentage of participants enrolled in dietary intervention phase who complete at least 6 intervention study visits including baseline, middle, and final visit.

  Either after the endline visit or when participant is withdrawn or withdraws from study

Secondary Outcomes (1)

• Treatment-specific adherence rates

  Either after the endline visit or when participant is withdrawn or withdraws from study

Other Outcomes (23)

• Bone turnover markers

  Pre-intervention; during the intervention (at 3 and 6 weeks into the intervention)

• Body fat percentage

  Pre-intervention; during the intervention (at 6 weeks into the intervention)

• Fat mass index

  Pre-intervention; during the intervention (at 6 weeks into the intervention)

Study Arms (2)

Very low carbohydrate ketogenic diet for six weeks

EXPERIMENTAL

Other: Very low carbohydrate ketogenic diet

Mediterranean diet for six weeks

ACTIVE COMPARATOR

Other: Mediterranean diet

Interventions

Very low carbohydrate ketogenic diet OTHER

Very low carbohydrate ketogenic diet provided for six weeks

Very low carbohydrate ketogenic diet for six weeks

Mediterranean diet OTHER

Mediterranean diet provided for six weeks

Mediterranean diet for six weeks

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Ketosis

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Cora Best, PhD, RDN

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment of some but not all outcomes will be masked. More specifically, assessment of all outcomes determined by laboratory assay will be masked (e.g., bone turnover markers and 24-hour urine analytes).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: January 12, 2024
• Study Start: July 15, 2024
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available indefinitely after 3 years following study completion
• Access Criteria: Reasonable request

Locations

US (1)