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New treatment option for Postmenopausal Osteoporosis
Official title Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females
ClinicalTrials.gov ID: NCT07365514
What this study is testing
What is Blackcurrant (BC) extract?
Blackcurrant (BC) extract is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postmenopausal osteoporosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Storrs, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Storrs, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.