Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females (NCT07365514) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females
United States159 participantsStarted 2026-02-01
Plain-language summary
The goal of this clinical trial is to evaluate the effects of blackcurrant (BC) supplementation on changes in bone density and gut microbiome composition in postmenopausal females.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* postmenopausal (defined as no more than 10 years since final menstrual cycle) females aged 45-70 years
* not on hormone replacement therapy for at least one year before initiation of the study
* maintaining normal exercise level (\< 7 hours/week) and willing to avoid exercise for 24 hours prior to blood and stool sampling
* willing to ingest a dietary blackcurrant supplement or placebo (up to 1,176 mg/day, three 392mg capsules)
* 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 three blood draws, three stool collections, and three bone scans
Exclusion Criteria:
* history of cardiovascular disease, osteoporosis, metabolic bone disease, cancer, diabetes mellitus, arthritis, or other chronic inflammatory diseases
* current smokers
* taking prescription medications known to alter bone and calcium metabolism
* taking anabolic agents such as parathyroid hormone or growth hormone, or steroid within 3 months before the start of the study
* taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
* alcohol consumption exceeding 2 drinks/day (approximately 14g of ethanol per drink) or a total of 12/week
* those with planned surgery during the study period or within 2 weeks of ending the intervention
* those with sensitivi…