The Paleolithic Diet and Male Factor Infertility

Male Infertility Clinical Trial

Official title:

The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01346631
• Other study ID #: 0130-10-EMC
• Status: Withdrawn
• Phase: N/A
• First received: May 1, 2011
• Last updated: June 21, 2015
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Months and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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.

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm Parameters	volume, concentration, motility, morphology	3 months	No
Secondary	Biomedical Indexes	Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin.	3 months	Yes