Benefits of Walnuts for Male Reproductive Health
Primary Purpose
Infertility, Nutrition Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Whole walnuts
Sponsored by
About this trial
This is an interventional prevention trial for Infertility focused on measuring Andrology, Fertility, Reproduction, Diet, Nutritional Sciences, Fatty Acids, Antioxidants, Body weight changes
Eligibility Criteria
Inclusion Criteria: Males
- Age 21 to 35 years
- Residence is in West Los Angeles for the next three months
- Non-smoker
- Free from chronic diseases requiring medications
- Free from nut allergies or nut intolerance
- Not taking anti-oxidant supplements
Exclusion Criteria:
- Outside the age range of 21 to 35 years
- Residence outside West Los Angeles area prohibiting two trips to the clinical research laboratory
- Current smoker
- Taking medications for chronic disease
- Nut allergies or nut intolerance
- Taking anti-oxidant supplements -
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Western style diet
Whole walnuts
Arm Description
Participants will consume their usual Western style diet avoiding tree nuts
Participants will consume usual Western style diet adding 75 gm whole walnuts per day
Outcomes
Primary Outcome Measures
change from baseline in semen quality at 12 weeks
semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
change from baseline in serum fatty acids at 12 weeks
change from baseline in serum selenium at 12 weeks
change from baseline in serum folate at 12 weeks
change from baseline in serum zinc at 12 weeks
Secondary Outcome Measures
change from baseline in body weight pounds at 12 weeks
change from baseline in nutrient intake at 12 weeks
Full Information
NCT ID
NCT01505140
First Posted
December 31, 2011
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
Collaborators
California Walnut Commission
1. Study Identification
Unique Protocol Identification Number
NCT01505140
Brief Title
Benefits of Walnuts for Male Reproductive Health
Official Title
Benefits of Walnuts for Male Reproductive Health
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
California Walnut Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other nutrients essential to sperm development and function. This randomized controlled trial sought to determine if a Western style diet supplemented with walnuts would improve sperm quality as a predictor of male fertility.
Detailed Description
A vast research base on human sperm shows the following to be critical for normal sperm development and function: Polyunsaturated fatty acids provide fluidity to sperm membranes allowing sperm to swim, fuse with ova, and support key cellular functions. Antioxidants protect sperm from reactive oxygen species generated during normal physiologic processes or white blood cells that infiltrate into seminal fluid and injure membranes and fragment sperm DNA. Selenium is critical in the form of anti-oxidant selenoproteins protecting developing sperm in the testes and later selenium in the epididymis participates in cell shape for motility. Folate, in a recent study, was associated with decreased aneuploidy (abnormal number of chromosomes)in sperm. Deficiency in any of these factors - lipids, antioxidants, selenium, or folate could manifest as poor semen quality and sub-fertility.
Walnuts provide a rich dietary source of each of the critical factors discussed above. Walnuts contain beneficial lipids, antioxidants, selenium, and folate. Walnuts, as a natural whole food source, may be preferential to commercial supplements and, as a plant source of nutrients, leave a positive green footprint on the planet.
Hypothesis The investigators hypothesize that diets enriched in walnuts will improve semen quality. Semen quality is a predictive marker for male infertility and sub-fertility, thus, the overall goal is to determine if dietary intake of walnuts will benefit male reproductive health.
A randomized, controlled intervention will be used to study the effects of walnut supplementation on semen quality measures in young men (ages 21 to 35) eating Western diets. Participants will be enrolled from the West Los Angeles area (n=120). Men will be randomly assigned to consume 3 oz of walnuts per day as part of their usual diet or to continue their habitual diet but avoid nuts. Each will follow the assigned diet for three months to cover one complete cycle of spermatogenesis.
The specific aims of the study are to:
Establish at baseline: habitual diet; serum omega-3 to omega-6 ratio, serum selenium and folate; semen quality (sperm count, motility, morphology) and sperm DNA integrity (COMET assay); sperm aneuploidy; and semen anti-oxidant levels
Randomly assign men to habitual diet plus 3 oz walnuts per day or usual diet without nuts for three months monitored by six telephone 24 hour dietary recalls
Compare intervention and control groups at three months on blood and semen measures
Compare blood and semen measures within man between baseline and three months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Nutrition Disorders
Keywords
Andrology, Fertility, Reproduction, Diet, Nutritional Sciences, Fatty Acids, Antioxidants, Body weight changes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Western style diet
Arm Type
No Intervention
Arm Description
Participants will consume their usual Western style diet avoiding tree nuts
Arm Title
Whole walnuts
Arm Type
Experimental
Arm Description
Participants will consume usual Western style diet adding 75 gm whole walnuts per day
Intervention Type
Other
Intervention Name(s)
Whole walnuts
Intervention Description
75 gm whole walnuts per day will be consumed with usual Western style diet
Primary Outcome Measure Information:
Title
change from baseline in semen quality at 12 weeks
Description
semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
Time Frame
change from baseline at 12 weeks
Title
change from baseline in serum fatty acids at 12 weeks
Time Frame
change from baseline at 12 weeks
Title
change from baseline in serum selenium at 12 weeks
Time Frame
change from baseline at 12 weeks
Title
change from baseline in serum folate at 12 weeks
Time Frame
change from baseline at 12 weeks
Title
change from baseline in serum zinc at 12 weeks
Time Frame
change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
change from baseline in body weight pounds at 12 weeks
Time Frame
change from baseline at 12 weeks
Title
change from baseline in nutrient intake at 12 weeks
Time Frame
change from baseline at 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males
Age 21 to 35 years
Residence is in West Los Angeles for the next three months
Non-smoker
Free from chronic diseases requiring medications
Free from nut allergies or nut intolerance
Not taking anti-oxidant supplements
Exclusion Criteria:
Outside the age range of 21 to 35 years
Residence outside West Los Angeles area prohibiting two trips to the clinical research laboratory
Current smoker
Taking medications for chronic disease
Nut allergies or nut intolerance
Taking anti-oxidant supplements -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendie A Robbins, RN, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6919
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22895856
Citation
Robbins WA, Xun L, FitzGerald LZ, Esguerra S, Henning SM, Carpenter CL. Walnuts improve semen quality in men consuming a Western-style diet: randomized control dietary intervention trial. Biol Reprod. 2012 Oct 25;87(4):101. doi: 10.1095/biolreprod.112.101634. Print 2012 Oct.
Results Reference
result
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Benefits of Walnuts for Male Reproductive Health
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