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The Paleolithic Diet and Male Factor Infertility

This study has been withdrawn prior to enrollment.
(We didn't start the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346631
First Posted: May 3, 2011
Last Update Posted: June 23, 2015
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.
Information provided by:
HaEmek Medical Center, Israel
  Purpose
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.

Condition Intervention
Male Infertility Other: paleolithic diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Sperm Parameters [ Time Frame: 3 months ]
    volume, concentration, motility, morphology


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paleolithic diet
Subjects will adhere to a paleolithic diet for the duration of three months
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346631


Locations
Israel
HaEmek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Responsible Party: Dr. Amir Weiss/Senior Doctor, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01346631     History of Changes
Other Study ID Numbers: 0130-10-EMC
First Submitted: May 1, 2011
First Posted: May 3, 2011
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female