Osteopenia or OsteoporosisOsteoporosisNCT06135831
Effect of Consumption of Supplements and Enriched Olive Paste on Bone Metabolism Indices
A study testing Functional olive paste, Calciovitmag (CDCaMg) and Phosporovitmag (PDCaMg) in people with Osteopenia or Osteoporosis, run by University of the Aegean at 1 site in Greece.
Trial summary
It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of Ca, Vitamin D and Mg with or without enriched olive paste and with or without Vitamin C. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteopenia or Osteoporosis
- What is being tested?
- Functional olive paste, Calciovitmag (CDCaMg) and Phosporovitmag (PDCaMg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteGreece
- Study dates
- 15 Mar 2019to 30 Jun 2021
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 75 years old
- Screening for osteoporosis (t-score ≤ - 1 normal bone density, t-score ≤ 2.5 osteoporosis ) and osteopenia of the femur strength or spine (t-score between -1 and -2.5 )
Who cannot join
- Age > 75 y.o. and <45 y.o
- Diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Consumption of Vitamin C, D3, Ca Supplements and Olive Paste Enriched With Mountain Tea on Bone Metabolism Indices in Postmenopausal Women With Increased Osteoporosis' Risk: A Prospective Interventional Study
It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of Ca, Vitamin D and Mg with or without enriched olive paste and with or without Vitamin C. Changes in calciregulatory hormone were evaluated at the beginning of the study, at 5 and 12 months . Blood levels of vitamin D, vitamin C, Ca, Mg, the lipid profile, anthropometric indices and bone density were assessed at the beginning and at the end of the study.
Read the detailed description
: It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups: (I) nutritional intervention group(n=40) received daily 1000mg vitamin C, 500mg vitamin D3, 500mg calcium(Ca) and 300mg magnesium (Mg); (II) control group(n=42) received daily 500mg vitamin D3, 500mg Ca and 300mg Mg; (III) nutritional intervention group (n=18) received daily 150mg bisphosphonates, 500mg vitamin D3, 500mg Ca and 300mg Mg; and (IV) nutritional intervention group (n=15) received daily about 364 mg polyphenols via an innovative functional food (50g olive paste enriched with mountain tea extract) along with 500mg vitamin D3, 500mg Ca and 300mg Mg. Groups I -III received supplementation for a year whereas group IV for 5 months. Changes in calciregulatory hormone parathormone (PTH) were evaluated at the beginning of the study as well as at 5 and 12 months intervals. Blood levels of vitamin D, vitamin C, Ca, Mg and the lipid profile were assessed at the beginning and at the end of the study. Anthropometric indices (weight, body fat(Kg), Body Mass Index(BMI) and bone mineral density(BMD) were evaluated at the beginning and at the end of the study.
- Conditions
- Osteopenia or Osteoporosis
- Being tested
- Functional olive paste, Calciovitmag (CDCaMg), Phosporovitmag (PDCaMg), Control
- Keywords
- postmenopausal, osteopenia, osteoporosis, supplements, functional olive paste
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional olive pasteOther
Also called Olive paste enriched with mountain tea
Homogenised olive pastes, enriched with mountain tea, were supplied by two ac-credited Greek olive oil and olive products companies, Arcadian Taste and GAEA. The fortified olive pastes, contained 7.5 g of extra virgin olive oil, 3.75 g of salt, 3.75 g of grated oregano, 3.75 g of grated pepper, 7.5 g of grated garlic, 6.25 g of orange juice, 65 g of Kala-mon olives without seeds and 3 g of mountain tea and weighted 100 gr per portion size, as well.
Calciovitmag (CDCaMg)Other
Also called Vitamin C and D, Calcium and Magnesium
Vitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day
Phosporovitmag (PDCaMg)Other
Also called Bisphosphonates, Vitamin D, Calcium and Magnesium
Bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily
ControlOther
Vitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily
| Study group | Role | What they receive |
|---|---|---|
| Calciovitmag (CDCaMg) | Experimental | Daily supplementation of diet with vitamin C (1000 mg), vitamin D3 (500 mg), calcium (Ca) (500 mg ) and magnesium (Mg) (300 mg) Receives: Other: Calciovitmag (CDCaMg) |
| Control | Placebo comparator | Daily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg) Receives: Other: Control |
| Phosphorovitmag (PDCaMg) | Experimental | Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg) Receives: Other: Phosporovitmag (PDCaMg) |
| Functional Olive paste | Experimental | Daily supplementation of diet with 364 mg polyphenols via 50 g of an innovative functional food (Kalamata olive paste with mountain tea rich in polyphenols, (total phenolics 7,28±3.11 gallic acid/g) along with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg) Receives: Other: Functional olive paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in calciregulatory hormone parathormone
Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months
Measured: 12 months
Secondary outcomes (7)
Changes in Vitamin D
Changes in Vitamin D at baseline and 12 months
Measured: 12 months
Changes in Calcium
Changes in Calcium at baseline and 12 months
Measured: 12 months
Changes in Vitamin C
Changes in Vitamin C at baseline and 12 months
Measured: 12 months
Changes in Magnesium
Changes in Magnesium at baseline and 12 months
Measured: 12 months
Changes in serum lipids
Changes in serum lipids at baseline and 12 months
Measured: 12 months
Changes in body weight, body mass index and body fat
Changes in body weight, body mass index and body fat at baseline and 12 months
Measured: 12 months
Changes in Bone Mineral Density
Changes in Bone Mineral Density at baseline and 12 months
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 posted18 Nov 2023
- Study start15 Mar 2019
- Primary completion15 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia or 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each study arm received different supplementation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Aegean
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135831
- Sponsor's protocol ID
- Osteo21
- Acronym
- Osteoporosis
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No one individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of Vitamin C, D3, Ca Supplements and Olive Paste Enriched With Mountain Tea on Bone Metabolism Indices in Postmenopausal Women With Increased Osteoporosis' Risk: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06135831
- Acronym / sponsor ID
- Osteoporosis / Osteo21
- Conditions
- Osteopenia or Osteoporosis
- Keywords
- postmenopausal, osteopenia, osteoporosis, supplements, functional olive paste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of the AegeanUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Nov 2023 (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 was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of Ca, Vitamin D and Mg with or without enriched olive paste and with or without Vitamin C. Changes in calciregulatory hormone were evaluated at the beginning of the study, at 5 and 12 months . Blood levels of vitamin D, vitamin C, Ca, Mg, the lipid profile, anthropometric indices and bone density were assessed at the beginning and at the end of the study.
Detailed description
: It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups: (I) nutritional intervention group(n=40) received daily 1000mg vitamin C, 500mg vitamin D3, 500mg calcium(Ca) and 300mg magnesium (Mg); (II) control group(n=42) received daily 500mg vitamin D3, 500mg Ca and 300mg Mg; (III) nutritional intervention group (n=18) received daily 150mg bisphosphonates, 500mg vitamin D3, 500mg Ca and 300mg Mg; and (IV) nutritional intervention group (n=15) received daily about 364 mg polyphenols via an innovative functional food (50g olive paste enriched with mountain tea extract) along with 500mg vitamin D3, 500mg Ca and 300mg Mg. Groups I -III received supplementation for a year whereas group IV for 5 months. Changes in calciregulatory hormone parathormone (PTH) were evaluated at the beginning of the study as well as at 5 and 12 months intervals. Blood levels of vitamin D, vitamin C, Ca, Mg and the lipid profile were assessed at the beginning and at the end of the study. Anthropometric indices (weight, body fat(Kg), Body Mass Index(BMI) and bone mineral density(BMD) were evaluated at the beginning and at the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each study arm received different supplementation.
| Arm | Type | Receives |
|---|---|---|
| Calciovitmag (CDCaMg) | Experimental | Other: Calciovitmag (CDCaMg)Daily supplementation of diet with vitamin C (1000 mg), vitamin D3 (500 mg), calcium (Ca) (500 mg ) and magnesium (Mg) (300 mg) |
| Control | Placebo comparator | Other: ControlDaily supplementation of diet with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg) |
| Phosphorovitmag (PDCaMg) | Experimental | Other: Phosporovitmag (PDCaMg)Daily supplementation of diet with bisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg) |
| Functional Olive paste | Experimental | Other: Functional olive pasteDaily supplementation of diet with 364 mg polyphenols via 50 g of an innovative functional food (Kalamata olive paste with mountain tea rich in polyphenols, (total phenolics 7,28±3.11 gallic acid/g) along with vitamin D3 (500 mg), Ca (500 mg) and Mg (300 mg) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 45 to 75 years old
- Screening for osteoporosis (t-score ≤ - 1 normal bone density, t-score ≤ 2.5 osteoporosis ) and osteopenia of the femur strength or spine (t-score between -1 and -2.5 )
Key exclusion criteria (2 listed)
- Age > 75 y.o. and <45 y.o
- Diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke
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 |
|---|---|---|
| Functional olive pasteAlso: Olive paste enriched with mountain teaHomogenised olive pastes, enriched with mountain tea, were supplied by two ac-credited Greek olive oil and olive products companies, Arcadian Taste and GAEA. The fortified olive pastes, contained 7.5 g of extra virgin olive oil, 3.75 g of salt, 3.75 g of grated oregano, 3.75 g of grated pepper, 7.5 g of grated garlic, 6.25 g of orange juice, 65 g of Kala-mon olives without seeds and 3 g of mountain tea and weighted 100 gr per portion size, as well. | Other | Functional Olive paste |
| Calciovitmag (CDCaMg)Also: Vitamin C and D, Calcium and MagnesiumVitamin C (1000 mg), vitamin D3 (500 mg), Calcium (Ca) (500 mg ) and Magnesium (Mg) (300 mg)/day | Other | Calciovitmag (CDCaMg) |
| Phosporovitmag (PDCaMg)Also: Bisphosphonates, Vitamin D, Calcium and MagnesiumBisphosphonates (150 mg), vitamin D3 (500 mg), Ca (500 mg ) and Mg (300 mg)/daily | Other | Phosphorovitmag (PDCaMg) |
| ControlVitamin D3 (500 mg), Calcium (500 mg) and Magnesium (300 mg)/daily | Other | Control |
Primary outcome
Changes in calciregulatory hormone parathormone
Time frame: 12 months
Changes in calciregulatory hormone parathormone (PTH) at baseline, 5 and 12 months
7 secondary outcomes
Changes in Vitamin D
Time frame: 12 months
Changes in Calcium
Time frame: 12 months
Changes in Vitamin C
Time frame: 12 months
Changes in Magnesium
Time frame: 12 months
Changes in serum lipids
Time frame: 12 months
Changes in body weight, body mass index and body fat
Time frame: 12 months
Changes in Bone Mineral Density
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 18 Nov 2023.
- Individual participant dataSharing planned: No. No one individual participant data will be shared
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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.
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 Functional olive paste, Calciovitmag (CDCaMg) and Phosporovitmag (PDCaMg) in people with Osteopenia or Osteoporosis, run by University of the Aegean 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 2 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 18 Nov 2023. 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. 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.
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?
Changes in calciregulatory hormone parathormone (time frame: 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 18 Nov 2023.