Male InfertilityNCT01346631
The Paleolithic Diet and Male Factor Infertility
A study testing paleolithic diet in people with Male Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. Read more about this study
- Who is it for?
- Ages 18 months and older, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- paleolithic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to May 2012
- 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 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- men with male infertility
- willingness to make dietary change for three months
- willingness to be blinded to sperm test results until the end of the experiment
Who cannot join
- High fever or abdominal or scrotal surgery during three months prior to intervention
- Change in diet, drinking or smoking habits in three months prior to intervention
- regular consumption of more than two servings of alcohol a day
- background ailment preventing dietary change
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility
Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. The investigators wanted to see if a "paleolithic diet" consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.
- Conditions
- Male Infertility
- Being tested
- paleolithic diet
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paleolithic dietOther
The diet consists of unlimited quantities of meat and fish, fruits and vegetables, eggs, nuts and water. Foods to be avoided include grains, wheat products, legumes, soy, potatoes and corn, rice, legumes, processed meats, soft drinks, dairy products and sugar. Allowed in moderation include coffee, alcohol,cooking oil, honey, salt, dried fruit.
| Study group | Role | What they receive |
|---|---|---|
| paleolithic diet | Experimental | Subjects will adhere to a paleolithic diet for the duration of three months Receives: Other: paleolithic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Parameters
volume, concentration, motility, morphology
Measured: 3 months
Secondary outcomes (1)
Biomedical Indexes
Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Why it stopped: We didn't start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346631
- Sponsor's protocol ID
- 0130-10-EMC
- Status last verified
- Jun 2015
- First submitted
- 1 May 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility
- ClinicalTrials.gov ID
- NCT01346631
- Acronym / sponsor ID
- 0130-10-EMC
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We didn't start the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 3 May 2011 (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.
Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. The investigators wanted to see if a "paleolithic diet" consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paleolithic diet | Experimental | Other: paleolithic dietSubjects will adhere to a paleolithic diet for the duration of three months |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- men with male infertility
- willingness to make dietary change for three months
- willingness to be blinded to sperm test results until the end of the experiment
Key exclusion criteria (4 listed)
- High fever or abdominal or scrotal surgery during three months prior to intervention
- Change in diet, drinking or smoking habits in three months prior to intervention
- regular consumption of more than two servings of alcohol a day
- background ailment preventing dietary change
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 |
|---|---|---|
| paleolithic dietThe diet consists of unlimited quantities of meat and fish, fruits and vegetables, eggs, nuts and water. Foods to be avoided include grains, wheat products, legumes, soy, potatoes and corn, rice, legumes, processed meats, soft drinks, dairy products and sugar. Allowed in moderation include coffee, alcohol,cooking oil, honey, salt, dried fruit. | Other | paleolithic diet |
Primary outcome
Sperm Parameters
Time frame: 3 months
volume, concentration, motility, morphology
1 secondary outcome
Biomedical Indexes
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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?
A study testing paleolithic diet in people with Male Infertility, run by HaEmek Medical Center, Israel 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 4 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: withdrawn, as of the sponsor's last update on 23 Jun 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sperm Parameters (time frame: 3 months). 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 Jun 2015.