Blackcurrant Extract for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests blackcurrant extract to determine its effects on bone health and gut bacteria in postmenopausal women. Researchers aim to discover if this supplement can improve bone density and alter the gut microbiome. Participants will receive either a low or high dose of blackcurrant extract or a placebo (a pill with no active ingredient). The trial seeks women who have stopped having periods for up to 10 years, are not on hormone therapy, and can discontinue other supplements during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
If you are taking medications that affect bone and calcium metabolism, or medications that alter bleeding, you will need to stop taking them to participate in the trial. The protocol does not specify other medications, but you should discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier research has shown that blackcurrant extract may reduce the risk of bone loss in postmenopausal women. Specifically, taking 784 mg of blackcurrant powder daily for six months helped prevent bone loss. While these results are encouraging, most studies have been conducted on cells and animals. Therefore, although blackcurrant extract appears safe, its full effects on humans remain under investigation.
At this early stage, the main goal is to determine if the treatment is safe for people. It might be well-tolerated, but researchers are still gathering evidence. If considering participation in such a trial, discussing any concerns with a doctor is advisable.12345Why do researchers think this study treatment might be promising for osteoporosis?
Unlike the standard treatments for osteoporosis, which often include bisphosphonates or hormone-related therapies, blackcurrant extract offers a natural alternative. Researchers are excited about blackcurrant extract because it is rich in antioxidants and may promote bone health by reducing oxidative stress and inflammation, which are key factors in bone loss. This natural approach could provide a gentler option with potentially fewer side effects compared to conventional drugs. Additionally, the study is exploring both low and high doses of blackcurrant extract, which may help optimize its effectiveness for preventing or treating osteoporosis.
What evidence suggests that blackcurrant extract might be an effective treatment for osteoporosis?
This trial will compare different doses of blackcurrant extract for their effects on osteoporosis. Research suggests that blackcurrant extract might help reduce bone loss in postmenopausal women. In one study, women taking blackcurrant supplements lost less bone strength compared to those who did not. Blackcurrants may help by affecting certain proteins that maintain bone strength and might also improve gut health, indirectly supporting bone health. Early animal studies have shown that blackcurrant extract can improve bone strength. Overall, promising evidence suggests that blackcurrants could help manage osteoporosis.14567
Who Is on the Research Team?
Ock Chun, PhD
Principal Investigator
University of Connecticut
Are You a Good Fit for This Trial?
This trial is for postmenopausal females who are at risk of osteoporosis. Participants should be generally healthy with no major gastrointestinal issues or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive blackcurrant supplementation or placebo for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blackcurrant (BC) extract
Trial Overview
The study tests if blackcurrant extract can improve bone density and alter gut microbiome composition compared to a placebo. It's designed to see if these changes can reduce osteoporosis risk in postmenopausal women.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Low-dose BC extract
High-dose BC extract
Placebo (no BC extract)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Connecticut
Lead Sponsor
Citations
Blackcurrants Reduce the Risk of Postmenopausal Osteoporosis
Overall, blackcurrant supplementation decreased the loss of whole-body bone mineral density (BMD) compared to the control group (p < 0.05), ...
Blackcurrants shape gut microbiota profile and reduce risk ...
Blackcurrants may mitigate bone loss in adult women in menopause transition. Blackcurrants bone protective effects may be through osteoclastic cytokine ...
3.
portal.nifa.usda.gov
portal.nifa.usda.gov/web/crisprojectpages/1007778-blackcurrant-prevents-osteoporosis-associated-with-aging-by-inhibiting-formation-of-advanced-oxidation-protein-products.htmlBlackcurrant Prevents Osteoporosis Associated with Aging by ...
Our preliminary studies with cell and animal models have shown that blackcurrant or its anthocyanin-rich extract is effective in reducing bone loss in ...
Blackcurrants Modify Gut Microbiota and Reduce ...
The proposed study will provide novel insight into whether and how BC consumption reduces the risk of postmenopausal bone loss and CVD in adult women.
Blackcurrant extract promotes differentiation of MC3T3‑E1 ...
Blackcurrant has also been shown to reduce the risk of osteoporosis and improve trabecular bone mass in young mice (23,24). Additionally, ...
6.
nal.usda.gov
nal.usda.gov/research-tools/food-safety-research-projects/blackcurrant-prevents-osteoporosis-associated-agingBlackcurrant Prevents Osteoporosis Associated with Aging by ...
Our preliminary studies with cell and animal models have shown that blackcurrant or its anthocyanin-rich extract is effective in reducing bone loss in ...
NCT04431960 | Blackcurrants Modify Gut Microbiota and ...
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women. Detailed Description.
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