Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Paleolithic Diet and Male Factor Infertility

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Information provided by:
HaEmek Medical Center, Israel Identifier:
First received: May 1, 2011
Last updated: May 2, 2011
Last verified: May 2011

May 1, 2011
May 2, 2011
May 2011
May 2012   (final data collection date for primary outcome measure)
Sperm Parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
volume, concentration, motility, morphology
Same as current
Complete list of historical versions of study NCT01346631 on Archive Site
Biomedical Indexes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.
Same as current
Not Provided
Not Provided
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 Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Not yet recruiting
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
18 Months and older
Contact: Amir Weiss, MD 972-4-6495565
Not Provided
Dr. Amir Weiss/Senior Doctor, Clalit Health Services
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
May 2011

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