NCT04431960

Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

Completed Phase 1 Results posted Last updated 12 August 2025

What this trial tests

Phase 1 trial testing blackcurrant (BC) extract in Postmenopausal Osteoporosis in 51 participants. Completed in 3 October 2022.

Timeline

20 July 2021

Primary endpoint
3 October 2022

3 October 2022

Quick facts

Lead sponsor	University of Connecticut
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	51
Start date	20 July 2021
Primary completion	3 October 2022
Estimated completion	3 October 2022
Sites	1 location across United States

Drugs / interventions tested

• blackcurrant (BC) extract — full drug profile →

Conditions studied

• Postmenopausal Osteoporosis — all drugs for Postmenopausal Osteoporosis →
• Gut Microbiota — all drugs for Gut Microbiota →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Connecticut

Who can join

Adults 45 to 60, female only, with Postmenopausal Osteoporosis or Gut Microbiota. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bone Mineral Density (BMD) Primary · From baseline to 6 months

Changes in BMD of whole-body measured via dual energy x-ray absorptiometry

Baseline

Group	Value	95% CI
Low-BC Group	1.14	± 0.13
High-BC Group	1.15	± 0.08
Control Group	1.17	± 0.13

6 month

Group	Value	95% CI
Low-BC Group	1.14	± 0.12
High-BC Group	1.17	± 0.08
Control Group	1.16	± 0.13

Serum Marker of Bone Formation Secondary · From baseline to 6 months

Changes to serum concentrations of P1NP

Baseline

Group	Value	95% CI
Low-BC Group	26.55	± 10.43
High-BC Group	21.21	± 10.09
Control Group	32.53	± 20.93

6 months

Group	Value	95% CI
Low-BC Group	25.99	± 10.27
High-BC Group	41.79	± 39.47
Control Group	26.36	± 17.71

Plasma Regulator of Bone Metabolism Secondary · From baseline to 6 months

Changes to plasma concentrations RANKL

Baseline

Group	Value	95% CI
Low-BC Group	211.12	± 89.94
High-BC Group	133.99	± 111.89
Control Group	256.81	± 110.39

6 months

Group	Value	95% CI
Low-BC Group	210.15	± 90.43
High-BC Group	102.09	± 112.51
Control Group	284.47	± 111.00

Changes in Plasma Inflammatory Cytokine Secondary · From baseline to 6 months

Changes to plasma concentrations of IL-1B

Baseline

Group	Value	95% CI
Low-BC Group	16.73	± 1.85
High-BC Group	15.36	± 2.44
Control Group	17.95	± 2.09

6 months

Group	Value	95% CI
Low-BC Group	16.66	± 1.85
High-BC Group	15.06	± 2.44
Control Group	18.34	± 2.09

Fasting Blood Lipids Secondary · from baseline to 6 months

Changes in plasma CVD risk factors (total cholesterol \[TC\], high density lipoprotein \[HDL\] and triglycerides \[TG\])

TC (baseline)

Group	Value	95% CI
Low-BC Group	179.7	± 9.5
High-BC Group	194.0	± 10.8
Control Group	178.1	± 9.9

TC (3 months)

Group	Value	95% CI
Low-BC Group	177.5	± 9.1
High-BC Group	196.7	± 10.2
Control Group	180.5	± 9.4

TC (6 months)

Group	Value	95% CI
Low-BC Group	167.6	± 9.7
High-BC Group	194.2	± 11.0
Control Group	184.0	± 10.1

HDL (baseline)

Group	Value	95% CI
Low-BC Group	62.0	± 4.2
High-BC Group	70.8	± 4.7
Control Group	71.5	± 4.3

HDL (3 months)

Group	Value	95% CI
Low-BC Group	62.9	± 4.7
High-BC Group	71.6	± 5.3
Control Group	72.3	± 4.8

HDL (6 months)

Group	Value	95% CI
Low-BC Group	59.9	± 4.5
High-BC Group	73.5	± 5.0
Control Group	72.8	± 4.6

TG (baseline)

Group	Value	95% CI
Low-BC Group	112.8	± 10.8
High-BC Group	78.1	± 12.2
Control Group	68.4	± 11.2

TG (3 months)

Group	Value	95% CI
Low-BC Group	106.5	± 9.6
High-BC Group	87.4	± 10.9
Control Group	75.5	± 10.0

Sponsor's own description

Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Treatments for Osteoporosis-Which Combination of Pills Is the Best among the Bad?
   Tonk CH, Shoushrah SH, Babczyk P, El Khaldi-Hansen B, et al · · 2022 · cited 30× · PMID 35163315 · DOI 10.3390/ijms23031393
2. Blackcurrants shape gut microbiota profile and reduce risk of postmenopausal osteoporosis via the gut-bone axis: Evidence from a pilot randomized controlled trial.
   Nosal BM, Thornton SN, Darooghegi Mofrad M, Sakaki JR, et al · · 2024 · cited 11× · PMID 39019119 · DOI 10.1016/j.jnutbio.2024.109701
3. Blackcurrants Reduce the Risk of Postmenopausal Osteoporosis: A Pilot Double-Blind, Randomized, Placebo-Controlled Clinical Trial.
   Nosal BM, Sakaki JR, Macdonald Z, Mahoney K, et al · · 2022 · cited 7× · PMID 36501004 · DOI 10.3390/nu14234971
4. Blackcurrant Anthocyanins Attenuate Estrogen -Deficiency-Induced Bone Loss through Modulating Microbial-Derived Short-Chain Carboxylic Acids and Phytoestrogen Metabolites in Peri- and Early Postmenopausal Women.
   Nosal BM, Thornton SN, Melnik AV, Lotfi A, et al · · 2024 · cited 3× · PMID 39452922 · DOI 10.3390/metabo14100541
5. Blackcurrant Anthocyanins Improve Blood Lipids and Biomarkers of Inflammation and Oxidative Stress in Healthy Women in Menopause Transition without Changing Body Composition.
   Nosal BM, Sakaki JR, Mofrad MD, Macdonald Z, et al · · 2023 · cited 2× · PMID 37893207 · DOI 10.3390/biomedicines11102834