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
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01346631
First received: May 1, 2011
Last updated: May 2, 2011
Last verified: May 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    volume, concentration, motility, morphology


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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

Ages Eligible for Study:   18 Months and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346631

Contacts
Contact: Amir Weiss, MD 972-4-6495565 weiss_am@clalit.org.il

Locations
Israel
HaEmek Medical Center Not yet recruiting
Afula, Israel
Contact: Amir Weiss, MD    972-4-6495565    weiss_am@clalit.org.il   
Principal Investigator: Amir Weiss, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr. Amir Weiss/Senior Doctor, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01346631     History of Changes
Other Study ID Numbers: 0130-10-EMC
Study First Received: May 1, 2011
Last Updated: May 2, 2011
Health Authority: Israel: Department of Health

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

ClinicalTrials.gov processed this record on July 26, 2014