Gonadotrophin and Sex Hormone ChangesNCT02931006
Influence of Bovine Milk Consumption on Hormonal Profile in Males
A study testing water and bovine milk in people with Gonadotrophin and Sex Hormone Changes, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gonadotrophin and Sex Hormone Changes
- What is being tested?
- water and bovine milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2019
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, non infertile males
Who cannot join
- lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gonadotrophin and Sex Hormone Changes
- Being tested
- water, bovine milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterOther
bovine milkOther
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Not described Receives: Other: water |
| experimental | Active comparator | Not described Receives: Other: bovine milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
sex hormone profile
gonadotropin levels (Testosterone, Estradiol)
Measured: 4 hours after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonadotrophin and Sex Hormone ChangesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931006
- Sponsor's protocol ID
- Bovine Milk-HMO-CTIL
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bovine Milk Consumption on Hormonal Profile in Males
- ClinicalTrials.gov ID
- NCT02931006
- Acronym / sponsor ID
- Bovine Milk-HMO-CTIL
- Conditions
- Gonadotrophin and Sex Hormone Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Ministry of Health, Israel
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 12 Oct 2016 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: water |
| experimental | Active comparator | Other: bovine milk |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, non infertile males
Key exclusion criteria (1 listed)
- lactose intolerance
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 |
|---|---|---|
| water | Other | control |
| bovine milk | Other | experimental |
Primary outcome
sex hormone profile
Time frame: 4 hours after consumption
gonadotropin levels (Testosterone, Estradiol)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water and bovine milk in people with Gonadotrophin and Sex Hormone Changes, run by Hadassah Medical Organization 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 1 inclusion and 1 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 12 Oct 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Kochman, MD (00 972 50 8946414, kochman.ronit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sex hormone profile (time frame: 4 hours after consumption). 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 12 Oct 2016.