NCT07365514

Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females

Blackcurrants Mitigate Postmenopausal Bone Loss Through Gut Microbiota-Bone Axis: A Randomized Clinical Trial Coupled With a Multi-Omics Approach to Inform Precision Nutrition

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: University of Connecticut · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Blackcurrant (BC) extract	Consume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule)
DRUG	Blackcurrant (BC) extract	Consume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule)
DRUG	Placebo	Consume three placebo capsules (392 mg placebo per capsule)

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2029-09-01
• First posted: 2026-01-26
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study