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The Paleolithic Diet and Male Factor Infertility
The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility
1 other identifier
interventional
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2011
1 active site
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
May 1, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 23, 2015
June 1, 2015
1 year
May 1, 2011
June 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Sperm Parameters
volume, concentration, motility, morphology
3 months
Secondary Outcomes (1)
Biomedical Indexes
3 months
Study Arms (1)
paleolithic diet
EXPERIMENTALSubjects will adhere to a paleolithic diet for the duration of three months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HaEmek Medical Center
Afula, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 1, 2011
First Posted
May 3, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 23, 2015
Record last verified: 2015-06