Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT06203392
Eligibility Criteria:
Inclusion 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%
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
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT06203392
Study Brief:
Protocol Section:
NCT06203392