Back to resultsThe Paleolithic Diet and Male Factor Infertility
Primary Purpose
Male Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
paleolithic diet
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- HaEmek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paleolithic diet
Arm Description
Subjects will adhere to a paleolithic diet for the duration of three months
Outcomes
Primary Outcome Measures
Sperm Parameters
volume, concentration, motility, morphology
Secondary Outcome Measures
Biomedical Indexes
Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.
Full Information
NCT ID
NCT01346631
First Posted
May 1, 2011
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01346631
Brief Title
The Paleolithic Diet and Male Factor Infertility
Official Title
The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
We didn't start the study
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paleolithic diet
Arm Type
Experimental
Arm Description
Subjects will adhere to a paleolithic diet for the duration of three months
Intervention Type
Other
Intervention Name(s)
paleolithic diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sperm Parameters
Description
volume, concentration, motility, morphology
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Biomedical Indexes
Description
Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Paleolithic Diet and Male Factor Infertility
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