Blackcurrant Extract for Osteoporosis

Overseen By Briana Nosal, MS

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Connecticut

Must not be taking: Anabolic agents, Steroids, Anticoagulants, others

Disqualifiers: Cardiovascular disease, Osteoporosis, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

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. ^{1 2 3 4 5}

Why 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. ^{1 4 5 6 7}

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

Willing to avoid other dietary supplements for the duration of the study

Maintaining normal exercise level (< 7 hours/week) and willing to avoid exercise for 24 hours prior to blood and stool sampling

I am willing to take a blackcurrant supplement or placebo as part of the study.

Exclusion Criteria

Current smokers

I have a history of heart disease, bone issues, cancer, diabetes, arthritis, or other long-term inflammatory conditions.

I am on medication that affects bone and calcium in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blackcurrant supplementation or placebo for 12 months

12 months

Monthly visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

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?

Group I: Low-BC Group Active Control 1 Intervention

Low-dose BC extract

Group II: High-BC Group Active Control 1 Intervention

High-dose BC extract

Group III: Control Group Placebo Group 1 Intervention

Placebo (no BC extract)

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9741267/

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), ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0955286324001347

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.html

Blackcurrant 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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04431960

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.

5.

spandidos-publications.com

spandidos-publications.com/10.3892/br.2024.1810?text=fulltext

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-aging

Blackcurrant 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 ...

7.

clinicaltrials.gov

clinicaltrials.gov/show/NCT04431960

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.