OsteopeniaOSTEOMENCT05421819
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms
A study testing Calcium and vitamin D supplement, Calcium, vitamin D and prebiotic supplement and Calcium, vitamin D and flavonoid supplement in people with Osteopenia and Postmenopausal Osteopenia, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Postmenopausal Osteopenia
- What is being tested?
- Calcium and vitamin D supplement, Calcium, vitamin D and prebiotic supplement and Calcium, vitamin D and flavonoid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jun 2022to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)
Who cannot join
- T-score in the osteoporotic range (T-score < -2.5) at any site
- Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
- Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
- Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
- Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory for Research of the Musculoskeletal System
Kifissia, Athens, 14561
About this study
Official title: Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment
It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. At the same time, interest in polyphenol-intestinal microbial interactions and in particular flavonoids and catechins has increased. Indeed, it has been observed that they are transformed via the microbe into bioactive compounds, and polyphenols themselves can modify the synthesis of the intestinal microbe.
OSTEOME aspires to design and develop a novel dietary supplement for osteoporosis, activating the intestinal microbiome. At the same time companion biomarkers will be studied related to the efficacy and tolerability of the new supplement. The selection of flavonoids will take place through in vitro and in silico studies focusing on their interaction with pathways that regulate the activity of osteoclasts and osteoblasts. The efficacy and tolerability of the dietary supplement will be evaluated through a randomized clinical intervention.
- Conditions
- Osteopenia, Postmenopausal Osteopenia
- Being tested
- Calcium and vitamin D supplement, Calcium, vitamin D and prebiotic supplement, Calcium, vitamin D and flavonoid supplement
- Keywords
- Dietary supplement for osteopenia, Calcium and vitamin D supplement, Calcium, vitamin D and prebiotics supplement, Calcium, vitamin D, prebiotics and flavonoids supplement, Bone turnover markers, Bone mineral density, Volumetric bone mineral density, Bone geometry, Postmenopausal osteopenia, Gut microbiota analysis
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium and vitamin D supplementDietary supplement
One hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 plus flavonoids once per day.
Calcium, vitamin D and prebiotic supplementDietary supplement
One hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 and flavonoids once per day.
Calcium, vitamin D and flavonoid supplementDietary supplement
One hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 and flavonoids once per day.
| Study group | Role | What they receive |
|---|---|---|
| Calcium and vitamin D supplement | Active comparator | In this arm, 50 women will receive calcium and vitamin D supplement once per day. Receives: Dietary Supplement: Calcium and vitamin D supplement |
| Calcium, vitamin D and prebiotic supplement | Active comparator | In this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day. Receives: Dietary Supplement: Calcium, vitamin D and prebiotic supplement |
| Calcium, vitamin D, prebiotic and flavonoid supplement | Active comparator | In this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day. Receives: Dietary Supplement: Calcium, vitamin D and flavonoid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone geometry
The primary endpoint is the within and between group change of bone geometry after 12 months of supplementation assessed by peripheral quantitative computed tomography (pQCT) of the tibia
Measured: 0 to 12 months
Secondary outcomes (5)
Areal bone mineral density (aBMD), trabecular bone score (TBS), adverse effects (tolerability) and adherence to dietary supplement after 12 months
The secondary endpoints is the within- and between-groups differences of the areal BMD (aBMD) at the lumbar spine (LS) and the total hip (TH) using dual-energy X-ray absorptiometry (DXA) and trabecular bone score (TBS) at LS, and the between-group comparison of the adverse effects (tolerability) and adherence to dietary supplement after 12 months.
Measured: 12 months
Bone turnover markers, PINP and CTX
Secondary endpoint is the within- and between-group comparison change of bone turnover markers after 3, 6 and 12 months of supplementation.
Measured: 3, 6 and 12 months
Change of serum TNF-α, IL-1, OPG, RANKL and IGF-1
Secondary endpoint is the within- and between-group comparison change of TNF-α, IL-1, OPG, RANKL and IGF-1 after 3, 6 and 12 months of supplementation.
Measured: 3, 6 and 12 months
Change of microMR1 Change of serum miRNAs
Secondary endpoint is the within- and between-group comparison change of miRNAs after 3, 6 and 12 months of supplementation.
Measured: 3, 6 and 12 months
Change of gut microbiota
Secondary endpoint is the within- and between-group comparison change of gut microbiota after 12 months of supplementation.
Measured: 12 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 2022
- Study start15 Jun 2022
- Primary completion15 Dec 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- National Hellenic Research Foundation
- Responsible party
- Principal investigator, EFSTATHIOS CHRONOPOULOS, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421819
- Sponsor's protocol ID
- 3847/22.03.2022
- Acronym
- OSTEOME
- Status last verified
- Mar 2024
- First submitted
- 26 May 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment
- ClinicalTrials.gov ID
- NCT05421819
- Acronym / sponsor ID
- OSTEOME / 3847/22.03.2022
- Conditions
- Osteopenia, Postmenopausal Osteopenia
- Keywords
- Dietary supplement for osteopenia, Calcium and vitamin D supplement, Calcium, vitamin D and prebiotics supplement, Calcium, vitamin D, prebiotics and flavonoids supplement, Bone turnover markers, Bone mineral density, Volumetric bone mineral density, Bone geometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- National Hellenic Research Foundation
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. At the same time, interest in polyphenol-intestinal microbial interactions and in particular flavonoids and catechins has increased. Indeed, it has been observed that they are transformed via the microbe into bioactive compounds, and polyphenols themselves can modify the synthesis of the intestinal microbe.
OSTEOME aspires to design and develop a novel dietary supplement for osteoporosis, activating the intestinal microbiome. At the same time companion biomarkers will be studied related to the efficacy and tolerability of the new supplement. The selection of flavonoids will take place through in vitro and in silico studies focusing on their interaction with pathways that regulate the activity of osteoclasts and osteoblasts. The efficacy and tolerability of the dietary supplement will be evaluated through a randomized clinical intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium and vitamin D supplement | Active comparator | Dietary Supplement: Calcium and vitamin D supplementIn this arm, 50 women will receive calcium and vitamin D supplement once per day. |
| Calcium, vitamin D and prebiotic supplement | Active comparator | Dietary Supplement: Calcium, vitamin D and prebiotic supplementIn this arm, 50 women will receive calcium, vitamin D and prebiotic supplement once per day. |
| Calcium, vitamin D, prebiotic and flavonoid supplement | Active comparator | Dietary Supplement: Calcium, vitamin D and flavonoid supplementIn this arm, 50 women will receive calcium, vitamin D, prebiotic and flavonoid supplement once per day. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women
- T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)
Key exclusion criteria (5 listed)
- T-score in the osteoporotic range (T-score < -2.5) at any site
- Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
- Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
- Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
- Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements
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 |
|---|---|---|
| Calcium and vitamin D supplementOne hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 plus flavonoids once per day. | Dietary supplement | Calcium and vitamin D supplement |
| Calcium, vitamin D and prebiotic supplementOne hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 and flavonoids once per day. | Dietary supplement | Calcium, vitamin D and prebiotic supplement |
| Calcium, vitamin D and flavonoid supplementOne hundred fifty postmenopausal women with osteopenia will be randomly and blindly allocated to receive in of the 3 different dietary supplements once per day. Patients of group A will receive orally 600 mg calcium and 2400 IU vitamin D3, group B will receive the same dose of calcium and vitamin D3 plus prebiotics once per day and group C will receive the same dose of calcium, vitamin D3 and flavonoids once per day. | Dietary supplement | Calcium, vitamin D, prebiotic and flavonoid supplement |
Primary outcome
Bone geometry
Time frame: 0 to 12 months
The primary endpoint is the within and between group change of bone geometry after 12 months of supplementation assessed by peripheral quantitative computed tomography (pQCT) of the tibia
5 secondary outcomes
Areal bone mineral density (aBMD), trabecular bone score (TBS), adverse effects (tolerability) and adherence to dietary supplement after 12 months
Time frame: 12 months
Bone turnover markers, PINP and CTX
Time frame: 3, 6 and 12 months
Change of serum TNF-α, IL-1, OPG, RANKL and IGF-1
Time frame: 3, 6 and 12 months
Change of microMR1 Change of serum miRNAs
Time frame: 3, 6 and 12 months
Change of gut microbiota
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Osteopenia
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium and vitamin D supplement, Calcium, vitamin D and prebiotic supplement and Calcium, vitamin D and flavonoid supplement in people with Osteopenia and Postmenopausal Osteopenia, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 2 inclusion and 5 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 7 Mar 2024. 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 Greece. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 geometry (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.