Blackcurrant supplementation to test bone density changes in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 1 trial will enroll postmenopausal women aged 45–70 to examine how daily blackcurrant extract affects bone mineral density at the whole body, lumbar spine, hip, and femoral neck over 12 months. A multi-omics approach will explore changes in gut microbiota, metabolites, and immune/endocrine signals that might relate to bone health. Participants will receive either blackcurrant extract or placebo and will undergo blood tests, stool collection, and bone density scans at scheduled intervals. The goal is to understand whether BC supplementation can mitigate bone loss through gut-related pathways while ensuring safety in this population.

Why it matters

Who can join: the full rules

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 sensitivities or allergies to any of the ingredients for the placebo (rice powder)
* planning a procedure that includes iodine, barium or nuclear medicine isotopes within the study period
* UConn students and/or employees who any key personnel teach or who report to any key personnel
* study key personnel, partners of key personnel, or dependents/relatives of any key personnel

Where it's running

• University of Connecticut, Department of Nutritional Sciences
  Storrs, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Ock Chun, PhD — University of Connecticut
• Study coordinator: Ock Chun, PhD
• Email: ock.chun@uconn.edu
• Phone: 860-486-6275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.