Postmenopausal OsteoporosisPhase 1NCT07365514
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females
A Phase 1 study testing Blackcurrant (BC) extract in people with Postmenopausal Osteoporosis and Gut Microbiome, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Gut Microbiome, Menopause
- What is being tested?
- Blackcurrant (BC) extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Connecticut, Department of Nutritional Sciences
Storrs, Connecticut, 06269
Ock Chun, PhD, 860-486-6275, ock.chun@uconn.edu
Briana Nosal, MS, 860-878-0679, briana.nosal@uconn.edu
About this study
Official title: Blackcurrants Mitigate Postmenopausal Bone Loss Through Gut Microbiota-Bone Axis: A Randomized Clinical Trial Coupled With a Multi-Omics Approach to Inform Precision Nutrition
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.
Read the detailed description
Postmenopausal osteoporosis (PMO) is a debilitating and progressive metabolic bone disorder caused by estrogen deficiency after menopause, leading to an imbalance in bone remodeling. Owing to its high morbidity and serious complications, substantial efforts have been devoted to its prevention and treatment. Emerging evidence indicates that the gut microbiome plays a pivotal role in bone health through immune and endocrine pathways, influencing bone turnover via cytokine signaling, metabolite production, and calcium balance.
Our previous 6-month trial suggested that blackcurrant (BC) may exert bone-protective effects through integrated effects on bone remodeling, gut microbiota, and metabolite signaling. Therefore, the overall goal of this study is to investigate the effects of BC supplementation on changes in gut microbiota and bone density in postmenopausal females and to elucidate the interrelationship of BC and gut microbiota with regard to bone loss mitigation. This will be accomplished using a multidisciplinary, comprehensive multi-omics approach to examine interactions among BC, gut microbiota, bacterial metabolites, and the immune and endocrine systems in relation to bone metabolism.
Investigators will conduct a randomized, placebo-controlled trial of BC supplementation for 12 months in postmenopausal females aged 45-70 years. The primary endpoint will be changes in whole-body, lumbar spine, total hip, and femoral neck bone mineral density. The secondary endpoint will be changes in biomarkers of bone remodeling. To further delineate underlying mechanisms, changes in the community structure of the gut microbiome, inflammatory-immune markers, and endocrine markers will be assessed. Additional analyses will include proteomics to identify protein biomarkers, metabolomics to identify key metabolites associated with BC supplementation and bone-related outcomes, and genotyping to evaluate genetic polymorphisms in bone-related genes.
The specific objectives of this study are to investigate the effects of BC extract on: 1) bone density and bone remodeling biomarkers; and 2) changes in gut microbiota abundance and composition, inflammatory-immune and endocrine biomarkers, protein biomarkers (proteomics), key metabolites (metabolomics), and their relationships with changes in bone density, including evaluation of genetic polymorphisms in bone-related genes (genomics).
This study will provide further insight into whether and how BC consumption may reduce the risk of postmenopausal bone and will improve understanding of the role of the gut microbiome in postmenopausal bone loss. Findings may provide novel insight into how anthocyanin-rich berries reduce PMO risk via the gut-bone axis and may support the development of future dietary recommendations and strategies for adult females approaching or experiencing menopause.
- Conditions
- Postmenopausal Osteoporosis, Gut Microbiome, Menopause
- Being tested
- Blackcurrant (BC) extract, Placebo
- Keywords
- blackcurrant, gut microbiome, osteoporosis, menopause, females, bone aging
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackcurrant (BC) extractDrug
Consume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule)
Blackcurrant (BC) extractDrug
Consume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule)
PlaceboDrug
Consume three placebo capsules (392 mg placebo per capsule)
| Study group | Role | What they receive |
|---|---|---|
| Low-BC Group | Active comparator | Low-dose BC extract Receives: Drug: Blackcurrant (BC) extract |
| High-BC Group | Active comparator | High-dose BC extract Receives: Drug: Blackcurrant (BC) extract |
| Control Group | Placebo comparator | Placebo (no BC extract) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
Changes from baseline in whole-body, lumbar spine, total hip and femoral neck BMD at months 6 and 12 measured via dual energy x-ray absorptiometry (DXA)
Measured: From baseline to months 6 and 12
Secondary outcomes (1)
Serum markers of bone remodeling
Changes in serum concentrations of bone remodeling markers including procollagen type I N-propeptide (P1NP), bone alkaline phosphatase (BALP), receptor activator of nuclear factor kappa-Β ligand (RANKL), and collagen Type I C-Telopeptide (CTX1)
Measured: From baseline to months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startJul 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned to one of three groups and asked to consume three capsules per day in the morning for 12 months as follows: 1) 3 capsules containing 784 mg blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule; low BC group); or 2) 3 capsules containing 1,176 mg BC extract (three 392 mg BC capsules; high BC group); or 3) 3 placebo capsules (392 mg placebo per capsule; control group).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ock Chun, University of Connecticut
- Investigators
- Ock Chun, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365514
- Sponsor's protocol ID
- B2025-0380
- Other IDs
- 2025-67018-45103, 2025
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once research proceedings and manuscripts are published, we will make our results available to both the community of scientists interested in postmenopausal osteoporosis and those studying the biology of inflammation-induced bone resorption and avoid unintentional duplication of research.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blackcurrants Mitigate Postmenopausal Bone Loss Through Gut Microbiota-Bone Axis: A Randomized Clinical Trial Coupled With a Multi-Omics Approach to Inform Precision Nutrition
- ClinicalTrials.gov ID
- NCT07365514
- Acronym / sponsor ID
- B2025-0380
- Conditions
- Postmenopausal Osteoporosis, Gut Microbiome, Menopause
- Keywords
- blackcurrant, gut microbiome, osteoporosis, menopause, females, bone aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postmenopausal osteoporosis (PMO) is a debilitating and progressive metabolic bone disorder caused by estrogen deficiency after menopause, leading to an imbalance in bone remodeling. Owing to its high morbidity and serious complications, substantial efforts have been devoted to its prevention and treatment. Emerging evidence indicates that the gut microbiome plays a pivotal role in bone health through immune and endocrine pathways, influencing bone turnover via cytokine signaling, metabolite production, and calcium balance.
Our previous 6-month trial suggested that blackcurrant (BC) may exert bone-protective effects through integrated effects on bone remodeling, gut microbiota, and metabolite signaling. Therefore, the overall goal of this study is to investigate the effects of BC supplementation on changes in gut microbiota and bone density in postmenopausal females and to elucidate the interrelationship of BC and gut microbiota with regard to bone loss mitigation. This will be accomplished using a multidisciplinary, comprehensive multi-omics approach to examine interactions among BC, gut microbiota, bacterial metabolites, and the immune and endocrine systems in relation to bone metabolism.
Investigators will conduct a randomized, placebo-controlled trial of BC supplementation for 12 months in postmenopausal females aged 45-70 years. The primary endpoint will be changes in whole-body, lumbar spine, total hip, and femoral neck bone mineral density. The secondary endpoint will be changes in biomarkers of bone remodeling. To further delineate underlying mechanisms, changes in the community structure of the gut microbiome, inflammatory-immune markers, and endocrine markers will be assessed. Additional analyses will include proteomics to identify protein biomarkers, metabolomics to identify key metabolites associated with BC supplementation and bone-related outcomes, and genotyping to evaluate genetic polymorphisms in bone-related genes.
The specific objectives of this study are to investigate the effects of BC extract on: 1) bone density and bone remodeling biomarkers; and 2) changes in gut microbiota abundance and composition, inflammatory-immune and endocrine biomarkers, protein biomarkers (proteomics), key metabolites (metabolomics), and their relationships with changes in bone density, including evaluation of genetic polymorphisms in bone-related genes (genomics).
This study will provide further insight into whether and how BC consumption may reduce the risk of postmenopausal bone and will improve understanding of the role of the gut microbiome in postmenopausal bone loss. Findings may provide novel insight into how anthocyanin-rich berries reduce PMO risk via the gut-bone axis and may support the development of future dietary recommendations and strategies for adult females approaching or experiencing menopause.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study participants will be randomly assigned to one of three groups and asked to consume three capsules per day in the morning for 12 months as follows: 1) 3 capsules containing 784 mg blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule; low BC group); or 2) 3 capsules containing 1,176 mg BC extract (three 392 mg BC capsules; high BC group); or 3) 3 placebo capsules (392 mg placebo per capsule; control group).
| Arm | Type | Receives |
|---|---|---|
| Low-BC Group | Active comparator | Drug: Blackcurrant (BC) extractLow-dose BC extract |
| High-BC Group | Active comparator | Drug: Blackcurrant (BC) extractHigh-dose BC extract |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo (no BC extract) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blackcurrant (BC) extractConsume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule) | Drug | Low-BC Group |
| Blackcurrant (BC) extractConsume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule) | Drug | High-BC Group |
| PlaceboConsume three placebo capsules (392 mg placebo per capsule) | Drug | Control Group |
Primary outcome
Bone Mineral Density (BMD)
Time frame: From baseline to months 6 and 12
Changes from baseline in whole-body, lumbar spine, total hip and femoral neck BMD at months 6 and 12 measured via dual energy x-ray absorptiometry (DXA)
1 secondary outcome
Serum markers of bone remodeling
Time frame: From baseline to months 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. Once research proceedings and manuscripts are published, we will make our results available to both the community of scientists interested in postmenopausal osteoporosis and those studying the biology of inflammation-induced bone resorption and avoid unintentional duplication of research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ock Chun, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blackcurrant (BC) extract in people with Postmenopausal Osteoporosis and Gut Microbiome, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ock Chun, PhD (860-486-6275, ock.chun@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: From baseline to months 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.