NCT02369289

Brief 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. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

February 16, 2015

Last Update Submit

February 16, 2015

Conditions

Bone Mineral DensityVegan Diet

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    1 day

Study Arms (2)

vegans

a vegan diet in the last 3 years

Other: bone mineral density test

omnivores

aminal-based diet, comsumption of aminal products at least 3 times a week

Other: bone mineral density test

Interventions

bone mineral density testOTHER
omnivoresvegans

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

generaly healthy vegan and omnivore females, age 30-45

You may qualify if:

  • generaly healthy
  • vegan group: vegan diet for the past 3 years
  • omnivore group: comsumption of animal products at least 3 times a week

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

Bone Density

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 23, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

IL(1)