NCT02931006

Brief Summary

50 men will be recruited to this study. Participants will be asked to ingest commercially available bovine milk. Hormonal profile will be analyzed before and after consumption.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 12, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 15, 2016

Last Update Submit

October 10, 2016

Conditions

Gonadotrophin and Sex Hormone Changes

Outcome Measures

Primary Outcomes (1)

  • sex hormone profile

    gonadotropin levels (Testosterone, Estradiol)

    4 hours after consumption

Study Arms (2)

control

PLACEBO COMPARATOR
Other: water

experimental

ACTIVE COMPARATOR
Other: bovine milk

Interventions

waterOTHER
control
bovine milkOTHER
experimental

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, non infertile males

You may not qualify if:

  • lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Ronit Kochman, MD

CONTACT

00 972 50 8946414kochman.ronit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

October 12, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

October 12, 2016

Record last verified: 2016-09

Locations

IL(1)