A Phase 1 interventional study of Blackcurrant (BC) extract and Blackcurrant (BC) extract in Postmenopausal Osteoporosis, Gut Microbiome and Menopause, sponsored by University of Connecticut. Recruiting at 1 site in United States. Open to female participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Connecticut · Phase 1, Interventional, and Prevention
Among 106 studies in Osteoporosis, Postmenopausal with a site in United States — 4 open to participants now, 11 under way, 1 of them phase 3. Osteoporosis, Postmenopausal · United States.
Among the 106 studies in Osteoporosis, Postmenopausal with a site in United States, this one is the 52nd largest by planned enrollment of the 95 interventional ones, is one of 2 that started in 2026, is one of 9 in phase 1, reaches primary completion later than 8 of the 10 other live ones, and was the 106th registered.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's planned enrollment of 159 is above the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →4 of the 106 studies in Osteoporosis, Postmenopausal with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 19 Osteoporosis, Postmenopausal studies recruiting now, 8 (42%) set no upper age limit and 7 (37%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 45 Years to 70 Years · female · healthy volunteers too.
The full table on the hub →106 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 2 started in 2026.
Median enrollment 201 across the 95 interventional studies, 101 across the 8 observational. Of the 92 that completed or were terminated, 49 (53%) have results posted.
62 of 106 have an industry lead sponsor. The 10 most frequent:
University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.
University of Connecticut has 2 studies filed under Osteoporosis, Postmenopausal — fewer than ten, so there is no comparison to draw.
4 of the studies in Osteoporosis, Postmenopausal with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06577935Angitia BiopharmaceuticalsA Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS) | 2026-12 |
| NCT05058976Susan L. GreenspanRomosozumab Use to Build Skeletal Integrity | 2027-03-31 |
| NCT05010590Massachusetts General HospitalAnabolic Therapy in Postmenopausal Osteoporosis | 2027-10-01 |
| NCT06558188Massachusetts General HospitalCombined Anabolic Therapy | 2027-11-02 |
Among the 106 studies in Osteoporosis, Postmenopausal with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low-dose BC extract
Drug: Blackcurrant (BC) extract
High-dose BC extract
Drug: Blackcurrant (BC) extract
Placebo (no BC extract)
Drug: Placebo
Consume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule)
Consume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule)
Consume three placebo capsules (392 mg placebo per capsule)
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)
Time frame: From baseline to months 6 and 12
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)
Time frame: From baseline to months 6 and 12
Changes in community structure of gut microbiota
Changes in gut microbial composition will be assessed using alpha diversity (species richness and Shannon diversity) and beta diversity metrics, including Bray-Curtis dissimilarity (community abundance) and Jaccard distance (presence/absence). Taxonomic composition will be compared between groups by evaluating relative abundance at the genus and phylum levels.
Time frame: from baseline to months 6 and 12
Plasma inflammatory-immune markers
Inflammatory biomarkers will be assessed in plasma, including IL-1beta and TNF-alpha. Additional immune response markers related to T helper cell subtypes (Th1, Th2, Th17) will be measured in plasma (e.g., interleukin (IL)-2, IL-4, IL-6, IL-10, TNF, IL-17A). CD4+ Th17 and regulatory T cell (Treg) responses will also be evaluated from peripheral blood mononuclear cells (PBMCs).
Time frame: from baseline to months 6 and 12
Plasma endocrine markers
Changes in plasma concentrations of endocrine markers including insulin-like growth factor-1 (IGF-1) and cyclic glycine-proline (cGP)
Time frame: from baseline to months 6 and 12
Omics outcomes
Metabolomics, proteomics, and genotyping will be performed to identify biomarkers associated with blackcurrant supplementation and bone-related outcomes.
Time frame: from baseline to months 6 and 12
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Unlimited time after papers are published.
Access criteria: Our plan for sharing of data generated by this project includes the following: Presentations at national scientific meeting. From the project, it is expected that approximately two presentations at national meetings would be appropriate. Publication in peer-reviewed journals. It is our explicit intention that the study findings and key data will be placed in a readily accessible public database. All efforts will be made to rapidly release data through publication of results as quickly as possible following our analysis of experiment data. Data used in publications will be released in a timely manner.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Feb 2028, 19 months later.
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Osteoporosis, Postmenopausal →