Trial Outcomes & Findings for Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk (NCT NCT04431960)
NCT ID: NCT04431960
Last Updated: 2025-08-12
Results Overview
Changes in BMD of whole-body measured via dual energy x-ray absorptiometry
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
From baseline to 6 months
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Low-BC Group
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
18
|
|
Overall Study
COMPLETED
|
16
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Baseline characteristics by cohort
| Measure |
Low-BC Group
n=16 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=11 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=13 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Caucasian
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian-American/Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
40 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsChanges in BMD of whole-body measured via dual energy x-ray absorptiometry
Outcome measures
| Measure |
Low-BC Group
n=16 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=11 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=13 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Bone Mineral Density (BMD)
Baseline
|
1.14 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.08
|
1.17 g/cm^2
Standard Deviation 0.13
|
|
Bone Mineral Density (BMD)
6 month
|
1.14 g/cm^2
Standard Deviation 0.12
|
1.17 g/cm^2
Standard Deviation 0.08
|
1.16 g/cm^2
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsChanges to serum concentrations of P1NP
Outcome measures
| Measure |
Low-BC Group
n=16 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=11 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=13 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Serum Marker of Bone Formation
Baseline
|
26.55 ng/mL
Standard Deviation 10.43
|
21.21 ng/mL
Standard Deviation 10.09
|
32.53 ng/mL
Standard Deviation 20.93
|
|
Serum Marker of Bone Formation
6 months
|
25.99 ng/mL
Standard Deviation 10.27
|
41.79 ng/mL
Standard Deviation 39.47
|
26.36 ng/mL
Standard Deviation 17.71
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsPopulation: Analysis was performed on 35 participants for RANKL due to missing values.
Changes to plasma concentrations RANKL
Outcome measures
| Measure |
Low-BC Group
n=15 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=10 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=10 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Plasma Regulator of Bone Metabolism
Baseline
|
211.12 pg/mL
Standard Error 89.94
|
133.99 pg/mL
Standard Error 111.89
|
256.81 pg/mL
Standard Error 110.39
|
|
Plasma Regulator of Bone Metabolism
6 months
|
210.15 pg/mL
Standard Error 90.43
|
102.09 pg/mL
Standard Error 112.51
|
284.47 pg/mL
Standard Error 111.00
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsPopulation: Analysis was performed on 36 participants for IL-1β due to missing values.
Changes to plasma concentrations of IL-1B
Outcome measures
| Measure |
Low-BC Group
n=15 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=9 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=12 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Changes in Plasma Inflammatory Cytokine
Baseline
|
16.73 pg/mL
Standard Error 1.85
|
15.36 pg/mL
Standard Error 2.44
|
17.95 pg/mL
Standard Error 2.09
|
|
Changes in Plasma Inflammatory Cytokine
6 months
|
16.66 pg/mL
Standard Error 1.85
|
15.06 pg/mL
Standard Error 2.44
|
18.34 pg/mL
Standard Error 2.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthsThis was measured using alpha diversity by species richness and Shannon diversity and beta diversity by principal component analysis. Structural comparisons were done comparing relative abundance between groups at the genus and phylum levels
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthschanges in serum inflammation biomarker (hs-CRP)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthsChanges in plasma CVD risk factors (total cholesterol \[TC\], high density lipoprotein \[HDL\] and triglycerides \[TG\])
Outcome measures
| Measure |
Low-BC Group
n=14 Participants
consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
High-BC Group
n=11 Participants
consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
Control Group
n=13 Participants
consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D
blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
|
|---|---|---|---|
|
Fasting Blood Lipids
TC (baseline)
|
179.7 mg/dL
Standard Deviation 9.5
|
194.0 mg/dL
Standard Deviation 10.8
|
178.1 mg/dL
Standard Deviation 9.9
|
|
Fasting Blood Lipids
TC (3 months)
|
177.5 mg/dL
Standard Deviation 9.1
|
196.7 mg/dL
Standard Deviation 10.2
|
180.5 mg/dL
Standard Deviation 9.4
|
|
Fasting Blood Lipids
TC (6 months)
|
167.6 mg/dL
Standard Deviation 9.7
|
194.2 mg/dL
Standard Deviation 11.0
|
184.0 mg/dL
Standard Deviation 10.1
|
|
Fasting Blood Lipids
HDL (baseline)
|
62.0 mg/dL
Standard Deviation 4.2
|
70.8 mg/dL
Standard Deviation 4.7
|
71.5 mg/dL
Standard Deviation 4.3
|
|
Fasting Blood Lipids
HDL (3 months)
|
62.9 mg/dL
Standard Deviation 4.7
|
71.6 mg/dL
Standard Deviation 5.3
|
72.3 mg/dL
Standard Deviation 4.8
|
|
Fasting Blood Lipids
HDL (6 months)
|
59.9 mg/dL
Standard Deviation 4.5
|
73.5 mg/dL
Standard Deviation 5.0
|
72.8 mg/dL
Standard Deviation 4.6
|
|
Fasting Blood Lipids
TG (baseline)
|
112.8 mg/dL
Standard Deviation 10.8
|
78.1 mg/dL
Standard Deviation 12.2
|
68.4 mg/dL
Standard Deviation 11.2
|
|
Fasting Blood Lipids
TG (3 months)
|
106.5 mg/dL
Standard Deviation 9.6
|
87.4 mg/dL
Standard Deviation 10.9
|
75.5 mg/dL
Standard Deviation 10.0
|
|
Fasting Blood Lipids
TG (6 months)
|
112.3 mg/dL
Standard Deviation 8.8
|
68.9 mg/dL
Standard Deviation 10.0
|
74.2 mg/dL
Standard Deviation 9.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthschanges in blood pressure (SBP/DBP), BMI, WC, body composition
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthschanges in plasma concentrations of immune biomarkers (IL-1β, IL-6, TNFα, Th17 and Treg)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 6 monthschanges in plasma concentrations of endocrine biomarkers
Outcome measures
Outcome data not reported
Adverse Events
Low-BC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-BC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place