Phase 1
Completed N=51
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Postmenopausal Osteoporosis · Gut Microbiota · Cardiovascular Disease
Source: ClinicalTrials.gov NCT04431960 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Bone Mineral Density (BMD) — 1.14; 1.15; 1.17; 1.14 g/cm^2
Summary
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) |
1.14; 1.15; 1.17; 1.14; 1.17; 1.16 | — |
| SECONDARY Serum Marker of Bone Formation |
26.55; 21.21; 32.53; 25.99; 41.79; 26.36 | — |
| SECONDARY Plasma Regulator of Bone Metabolism |
211.12; 133.99; 256.81; 210.15; 102.09; 284.47 | — |
| SECONDARY Changes in Plasma Inflammatory Cytokine |
16.73; 15.36; 17.95; 16.66; 15.06; 18.34 | — |
Eligibility Criteria
Inclusion Criteria
- perimenopausal or early postmenopausal women aged 45-60 years old
- not on HRT for at least one year before the initiation of the study
- maintaining normal exercise level ( 20 cigarettes/day)
- perimenopausal women with any chance or plan of pregnancy
- taking prescription medications known to alter bone and Ca metabolism such as calcitonin, bisphosphonates, raloxifene within 3 months before the start of the study
- taking anabolic agents such as parathyroid hormone, growth hormone, or steroids within 3 months before the start of the study
- planning any procedure that includes iodine, barium or nuclear medicine isotopes in next 7 months
- alcohol consumption exceeding 2 drinks/day (approximately 14 g ethanol per drink) or a total of 12/week
- UConn students and/or employees who any key personnel teach or who report to any key personnel
- study key personnel, spouses of key personnel, or dependents/relatives of any key personnel.
Data sourced from ClinicalTrials.gov (NCT04431960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.