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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT04431960
Eligibility Criteria:
Inclusion Criteria:
* perimenopausal or early postmenopausal women aged 45-60 years old
* not on HRT for at least one year before the initiation of the study
* maintaining normal exercise level (\<7 h/wk) and willing to avoid exercise 24-h prior to blood and stool sampling and 12-h prior to bone measurements
* willing to ingest a dietary BC supplement or placebo (up to 900 mg/day, two 450 mg capsules) as well as 400 mg calcium and 500 IU vitamin D daily
* willing to avoid other dietary supplements for the duration of the study
* willing to avoid intake of foods extremely rich in anthocyanins and fermented dairy products containing viable Bifidobacteria or Lactobacilli
* willing to have 3 blood draws, 2 stool collections, and 2 bone scans
* willing to take urine pregnancy test if they are perimenopausal.
Exclusion Criteria:
* those with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases
* those with hypertension or on drugs that lower blood pressure
* those with planned surgery during the study period or within 2 weeks of ending the intervention
* taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
* taking a phenothiazine drug (most commonly used for nausea or mental health conditions)
* having a sensitivity or allergy to any of ingredients for the placebo (rice powder) and calcium/D supplement (calcium citrate, polyethylene glycol, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, oligofructose enriched inulin, propylene glycol dicaprylate/dicaprate, talc, titanium dioxide, vitamin D3)
* heavy smokers (\>20 cigarettes/day)
* perimenopausal women with any chance or plan of pregnancy
* taking prescription medications known to alter bone and Ca metabolism such as calcitonin, bisphosphonates, raloxifene within 3 months before the start of the study
* taking anabolic agents such as parathyroid hormone, growth hormone, or steroids within 3 months before the start of the study
* planning any procedure that includes iodine, barium or nuclear medicine isotopes in next 7 months
* alcohol consumption exceeding 2 drinks/day (approximately 14 g ethanol per drink) or a total of 12/week
* UConn students and/or employees who any key personnel teach or who report to any key personnel
* study key personnel, spouses of key personnel, or dependents/relatives of any key personnel.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT04431960
Study Brief:
Protocol Section:
NCT04431960