- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369289
Bone Mineral Density in Israeli Female Vegans and Omnivores
February 16, 2015 updated by: Tel-Aviv Sourasky Medical Center
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel Aviv, Israel, 64239
- Clinical Nutrition Unit, Sourasky Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
generaly healthy vegan and omnivore females, age 30-45
Description
Inclusion Criteria:
- generaly healthy
- vegan group: vegan diet for the past 3 years
- omnivore group: comsumption of animal products at least 3 times a week
Exclusion Criteria:
- 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
- hypo/hyper parathyroidism
- smokimg in the past 10 years
- over consumption of alcohol (more than 7 units a week)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
vegans
a vegan diet in the last 3 years
|
|
|
omnivores
aminal-based diet, comsumption of aminal products at least 3 times a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
bone mineral density
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
February 1, 2016
Study Registration Dates
First Submitted
February 16, 2015
First Submitted That Met QC Criteria
February 16, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 16, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0013-15-TLV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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