The Paleolithic Diet and Male Factor Infertility
Recruitment status was Not yet recruiting
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.
|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|
- Sperm Parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]volume, concentration, motility, morphology
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346631
|Contact: Amir Weiss, MDfirstname.lastname@example.org|
|HaEmek Medical Center||Not yet recruiting|
|Contact: Amir Weiss, MD 972-4-6495565 email@example.com|
|Principal Investigator: Amir Weiss, MD|