COMPLETED

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

Conditions

Aging Musculoskeletal Diseases diet, aging, ketogenic, ketosis, Mediterranean

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-15

Study Completion:2025-11-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06203392

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.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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%	* 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

Inclusion Criteria

Exclusion Criteria

* 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%

* 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

Contacts and Locations

Principal Investigator

Cora Best, PhD, RDN

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15

Study Completion Date2025-11-24

Study Record Updates

Study Start Date2024-07-15

Study Completion Date2025-11-24

Terms related to this study

Keywords Provided by Researchers

diet, aging, ketogenic, ketosis, Mediterranean

Additional Relevant MeSH Terms

Aging
Musculoskeletal Diseases