Postmenopausal OsteoporosisPhase 1NCT04431960
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
A Phase 1 study testing blackcurrant (BC) extract in people with Postmenopausal Osteoporosis and Gut Microbiota, run by University of Connecticut at 1 site in United States.
Trial summary
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Gut Microbiota, Cardiovascular Diseases
- What is being tested?
- blackcurrant (BC) extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 3 Oct 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 (<7 h/wk) and willing to avoid exercise 24-h prior to blood and stool sampling and 12-h prior to bone measurements
- willing to ingest a dietary BC supplement or placebo (up to 900 mg/day, two 450 mg capsules) as well as 400 mg calcium and 500 IU vitamin D daily
- willing to avoid other dietary supplements for the duration of the study
- willing to avoid intake of foods extremely rich in anthocyanins and fermented dairy products containing viable Bifidobacteria or Lactobacilli
- willing to have 3 blood draws, 2 stool collections, and 2 bone scans
- willing to take urine pregnancy test if they are perimenopausal.
Who cannot join
- those with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases
- those with hypertension or on drugs that lower blood pressure
- those with planned surgery during the study period or within 2 weeks of ending the intervention
- taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
- taking a phenothiazine drug (most commonly used for nausea or mental health conditions)
- having a sensitivity or allergy to any of ingredients for the placebo (rice powder) and calcium/D supplement (calcium citrate, polyethylene glycol, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, oligofructose enriched inulin, propylene glycol dicaprylate/dicaprate, talc, titanium dioxide, vitamin D3)
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- heavy smokers (>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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Department of Nutritional Sciences and Kinesiology Human Performance Laboratory
Storrs, Connecticut, 06269
About this study
Official title: Blackcurrant Modifies Gut Microbiota and Reduces the Risk of Postmenopausal Osteoporosis and Cardiovascular Disease: A Pilot Randomized Clinical Trial
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
Read the detailed description
Postmenopausal bone loss is a primary contributor to osteoporosis and osteoporotic fractures in adult women in menopause transition. By following women over this period, studies have documented distinct patterns of a decrease in estrogen, a natural antioxidant, simultaneously with adverse alterations in body fat distribution, lipids and lipoproteins, and measures of vascular health, which can increase a woman's risk of developing CVD. Overall goal of this project is to evaluate the effects of blackcurrant (BC) supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women. For this purpose, the investigators will conduct a pilot randomized placebo-controlled clinical trial with BC supplementation for 6 months in peri- and early postmenopausal women aged 45-60 years.
The primary endpoint will be whole-body bone mineral density (BMD); secondary endpoints will be gut microbiota composition. To delineate the underlying mechanisms of the action, changes in biomarkers for bone metabolism, bone-related immune and endocrine systemic biomarkers, and CVD risk factors by BC supplementation will be measured in plasma and peripheral blood derived mononuclear cells.
The specific objectives of the study are to investigate the effects of BC extract on: 1) bone mass and bone remodeling markers; 2) changes in the gut microbiota abundance and composition, immune and endocrine biomarkers, and CVD risk factors and their relationships with changes in bone mass.
The proposed study will provide novel insight into whether and how BC consumption reduces the risk of postmenopausal bone loss and CVD in adult women and will improve understanding of the clinical roles of gut microbiome in postmenopausal bone loss. Findings from this study will help increase awareness of the bone and heart health promoting effect of BC and motivate increased production of BC and other berry products in response to the increasing consumer demand.
- Being tested
- blackcurrant (BC) extract
- Keywords
- blackcurrant, gut microbiome, osteoporosis, menopause, bone aging, women, cardiovascular disease
- Medical subject headings
- Osteoporosis, Postmenopausal, Cardiovascular Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blackcurrant (BC) extractDrug
Also called BPE75 (392 mg and 784 mg)
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
| Study group | Role | What they receive |
|---|---|---|
| low-BC Group | Active comparator | 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 Receives: Drug: blackcurrant (BC) extract |
| high-BC Group | Active comparator | 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 Receives: Drug: blackcurrant (BC) extract |
| Control Group | Placebo comparator | consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D Receives: Drug: blackcurrant (BC) extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
Changes in BMD of whole-body measured via dual energy x-ray absorptiometry
Measured: From baseline to 6 months
Secondary outcomes (3)
Serum Marker of Bone Formation
Changes to serum concentrations of P1NP
Measured: From baseline to 6 months
Plasma Regulator of Bone Metabolism
Changes to plasma concentrations RANKL
Measured: From baseline to 6 months
Changes in Plasma Inflammatory Cytokine
Changes to plasma concentrations of IL-1B
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Jul 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants will be randomly assigned to three groups and asked to consume 1 tablet containing 392 mg blackcurrant (BC) extract per capsule (low-BC Group), 2 capsules containing 392 mg BC extract per tablet (total 784 mg/day; high-BC Group), or 1 placebo capsule (Control Group) daily with breakfast meals for 6 months. To avoid bone deterioration related to calcium and vitamin D deficiency, all participants will take a calcium citrate caplet daily that includes 400 mg calcium and 500 IU vitamin D (Bayer AG, Germany) beginning 2 weeks before the study and lasting for the duration of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ock Chun, University of Connecticut
- Investigators
- Ock K Chun, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431960
- Sponsor's protocol ID
- HR20-0035
- Other IDs
- 2020-67018-30852
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2020
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once research proceedings and manuscripts are published we will make our results available both to the community of scientists interested in postmenopausal osteoporosis and to those studying the biology of inflammation-induced bone resorption to avoid unintentional duplication of research.
Publications
Nosal BM, Thornton SN, Darooghegi Mofrad M, Sakaki JR, Mahoney KJ, Macdonald Z, Daddi L, Tran TDB, Weinstock G, Zhou Y, Lee EC, Chun OK. Blackcurrants shape gut microbiota profile and reduce risk of postmenopausal osteoporosis via the gut-bone axis: Evidence from a pilot randomized controlled trial. J Nutr Biochem. 2024 Nov;133:109701. doi: 10.1016/j.jnutbio.2024.109701. Epub 2024 Jul 15.
PubMed 39019119
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blackcurrant Modifies Gut Microbiota and Reduces the Risk of Postmenopausal Osteoporosis and Cardiovascular Disease: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04431960
- Acronym / sponsor ID
- HR20-0035
- Keywords
- blackcurrant, gut microbiome, osteoporosis, menopause, bone aging, women, cardiovascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
Detailed description
Postmenopausal bone loss is a primary contributor to osteoporosis and osteoporotic fractures in adult women in menopause transition. By following women over this period, studies have documented distinct patterns of a decrease in estrogen, a natural antioxidant, simultaneously with adverse alterations in body fat distribution, lipids and lipoproteins, and measures of vascular health, which can increase a woman's risk of developing CVD. Overall goal of this project is to evaluate the effects of blackcurrant (BC) supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women. For this purpose, the investigators will conduct a pilot randomized placebo-controlled clinical trial with BC supplementation for 6 months in peri- and early postmenopausal women aged 45-60 years.
The primary endpoint will be whole-body bone mineral density (BMD); secondary endpoints will be gut microbiota composition. To delineate the underlying mechanisms of the action, changes in biomarkers for bone metabolism, bone-related immune and endocrine systemic biomarkers, and CVD risk factors by BC supplementation will be measured in plasma and peripheral blood derived mononuclear cells.
The specific objectives of the study are to investigate the effects of BC extract on: 1) bone mass and bone remodeling markers; 2) changes in the gut microbiota abundance and composition, immune and endocrine biomarkers, and CVD risk factors and their relationships with changes in bone mass.
The proposed study will provide novel insight into whether and how BC consumption reduces the risk of postmenopausal bone loss and CVD in adult women and will improve understanding of the clinical roles of gut microbiome in postmenopausal bone loss. Findings from this study will help increase awareness of the bone and heart health promoting effect of BC and motivate increased production of BC and other berry products in response to the increasing consumer demand.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study participants will be randomly assigned to three groups and asked to consume 1 tablet containing 392 mg blackcurrant (BC) extract per capsule (low-BC Group), 2 capsules containing 392 mg BC extract per tablet (total 784 mg/day; high-BC Group), or 1 placebo capsule (Control Group) daily with breakfast meals for 6 months. To avoid bone deterioration related to calcium and vitamin D deficiency, all participants will take a calcium citrate caplet daily that includes 400 mg calcium and 500 IU vitamin D (Bayer AG, Germany) beginning 2 weeks before the study and lasting for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| low-BC Group | Active comparator | Drug: blackcurrant (BC) extractconsume: 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 |
| high-BC Group | Active comparator | Drug: blackcurrant (BC) extractconsume: 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 |
| Control Group | Placebo comparator | Drug: blackcurrant (BC) extractconsume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 (<7 h/wk) and willing to avoid exercise 24-h prior to blood and stool sampling and 12-h prior to bone measurements
- willing to ingest a dietary BC supplement or placebo (up to 900 mg/day, two 450 mg capsules) as well as 400 mg calcium and 500 IU vitamin D daily
- willing to avoid other dietary supplements for the duration of the study
Key exclusion criteria (14 listed)
- those with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases
- those with hypertension or on drugs that lower blood pressure
- those with planned surgery during the study period or within 2 weeks of ending the intervention
- taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
- taking a phenothiazine drug (most commonly used for nausea or mental health conditions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blackcurrant (BC) extractAlso: BPE75 (392 mg and 784 mg)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 | Drug | Control Group, high-BC Group, low-BC Group |
Primary outcome
Bone Mineral Density (BMD)
Time frame: From baseline to 6 months
Changes in BMD of whole-body measured via dual energy x-ray absorptiometry
3 secondary outcomes
Serum Marker of Bone Formation
Time frame: From baseline to 6 months
Plasma Regulator of Bone Metabolism
Time frame: From baseline to 6 months
Changes in Plasma Inflammatory Cytokine
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39019119Nosal BM, Thornton SN, Darooghegi Mofrad M, Sakaki JR, Mahoney KJ, Macdonald Z, Daddi L, Tran TDB, Weinstock G, Zhou Y, Lee EC, Chun OK. Blackcurrants shape gut microbiota profile and reduce risk of postmenopausal osteoporosis via the gut-bone axis: Evidence from a pilot randomized controlled trial. J Nutr Biochem. 2024 Nov;133:109701. doi: 10.1016/j.jnutbio.2024.109701. Epub 2024 Jul 15.
- Individual participant dataSharing planned: Yes. Once research proceedings and manuscripts are published we will make our results available both to the community of scientists interested in postmenopausal osteoporosis and to those studying the biology of inflammation-induced bone resorption to avoid unintentional duplication of research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ock K Chun, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing blackcurrant (BC) extract in people with Postmenopausal Osteoporosis and Gut Microbiota, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.