The Paleolithic Diet and Male Factor Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346631
Recruitment Status : Withdrawn (We didn't start the study)
First Posted : May 3, 2011
Last Update Posted : June 23, 2015
Information provided by:
HaEmek Medical Center, Israel

May 1, 2011
May 3, 2011
June 23, 2015
May 2011
May 2012   (Final data collection date for primary outcome measure)
Sperm Parameters [ Time Frame: 3 months ]
volume, concentration, motility, morphology
Same as current
Complete list of historical versions of study NCT01346631 on Archive Site
Biomedical Indexes [ Time Frame: 3 months ]
Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.
Same as current
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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
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Male Infertility
Other: paleolithic diet
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.
Experimental: paleolithic diet
Subjects will adhere to a paleolithic diet for the duration of three months
Intervention: Other: paleolithic diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Months and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Dr. Amir Weiss/Senior Doctor, Clalit Health Services
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP