Bone Mineral DensityNCT02369289
Bone Mineral Density in Israeli Female Vegans and Omnivores
An observational study of Bone Mineral Density and Vegan Diet, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Mineral Density, Vegan Diet
- What is being tested?
- bone mineral density test
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Feb 2016
- Phase
- Observational
- 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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: generaly healthy vegan and omnivore females, age 30-45
Who may be able to join
- generaly healthy
- vegan group: vegan diet for the past 3 years
- omnivore group: comsumption of animal products at least 3 times a week
Who cannot join
- pragnent / breastfeeding women
- amenorrhea (absence of a menstrual period) for more than 3 months
- amenorrhea in the past
- significant underweight in the present/past (BMI < 17.5)
- taking medicine that affect bone density
- hypo/hyper thyroidism
Show all 9Show fewer
- hypo/hyper parathyroidism
- smokimg in the past 10 years
- over consumption of alcohol (more than 7 units a week)
Trial locations and contacts
1 site in 1 country.
About this study
A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.
- Conditions
- Bone Mineral Density, Vegan Diet
- Being tested
- bone mineral density test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone mineral density testOther
| Study group | Role | What they receive |
|---|---|---|
| vegans | a vegan diet in the last 3 years Receives: Other: bone mineral density test | |
| omnivores | aminal-based diet, comsumption of aminal products at least 3 times a week Receives: Other: bone mineral density test |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369289
- Sponsor's protocol ID
- 0013-15-TLV
- Status last verified
- Feb 2015
- First submitted
- 16 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density in Israeli Female Vegans and Omnivores
- ClinicalTrials.gov ID
- NCT02369289
- Acronym / sponsor ID
- 0013-15-TLV
- Conditions
- Bone Mineral Density, Vegan Diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- 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.
A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegans | – | Other: bone mineral density testa vegan diet in the last 3 years |
| omnivores | – | Other: bone mineral density testaminal-based diet, comsumption of aminal products at least 3 times a week |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- generaly healthy vegan and omnivore females, age 30-45
Key inclusion criteria (3 listed)
- generaly healthy
- vegan group: vegan diet for the past 3 years
- omnivore group: comsumption of animal products at least 3 times a week
Key exclusion criteria (9 listed)
- pragnent / breastfeeding women
- amenorrhea (absence of a menstrual period) for more than 3 months
- amenorrhea in the past
- significant underweight in the present/past (BMI < 17.5)
- taking medicine that affect bone density
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 |
|---|---|---|
| bone mineral density test | Other | omnivores, vegans |
Primary outcome
bone mineral density
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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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?
An observational study of Bone Mineral Density and Vegan Diet, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Feb 2015. 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 Israel. 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?
Results are not available in the source record.
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 (time frame: 1 day). 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 23 Feb 2015.