- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505140
Benefits of Walnuts for Male Reproductive Health
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-6919
- University of California, Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Western style diet
Participants will consume their usual Western style diet avoiding tree nuts
|
|
Experimental: Whole walnuts
Participants will consume usual Western style diet adding 75 gm whole walnuts per day
|
75 gm whole walnuts per day will be consumed with usual Western style diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline in semen quality at 12 weeks
Time Frame: change from baseline at 12 weeks
|
semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
|
change from baseline at 12 weeks
|
change from baseline in serum fatty acids at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
|
change from baseline in serum selenium at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
|
change from baseline in serum folate at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
|
change from baseline in serum zinc at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in body weight pounds at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
change from baseline in nutrient intake at 12 weeks
Time Frame: change from baseline at 12 weeks
|
change from baseline at 12 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 445246WR77518
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nutrition Disorders
-
NestléCompletedNutrition Disorder, ChildUnited Kingdom
-
Universidad de MonterreyFEMSA Foundation; Mexican Food BanksCompletedMalnutrition | Malnutrition, Child | Malnutrition in Children | Child Malnutrition | Child Overnutrition | Nutrition Disorders, ChildMexico
-
Harran UniversityRecruitingNutrition | Nutrition Disorder, InfantTurkey
-
Lata Medical Research Foundation, NagpurNational Health and Medical Research Council, Australia; Dimagi Inc.; ADVANCING...Unknown
-
Jimma UniversityUnknown
-
Danone Early Life Nutrition BrazilUniversidade Federal do Rio Grande do Norte; Federal University of Health Science... and other collaboratorsCompletedChild Nutrition Disorders
-
Augusta UniversityActive, not recruiting
-
FHI 360United States Agency for International Development (USAID); UNICEF; Ministry...TerminatedBreast Feeding | Nutrition | Child MalnutritionAfghanistan
-
Nemours Children's ClinicChildren's Hospital Medical Center, CincinnatiNot yet recruitingBody Composition | Feeding; Difficult, Newborn | Nutrition Disorder, InfantUnited States
-
NestléWithdrawnEnteral Feeding Intolerance | Tube Feeding | Nutrition Disorder, ChildUnited States
Clinical Trials on Whole walnuts
-
University of BelgradeCentre of Research Excellence in Nutrition and MetabolismCompletedHypertension | Metabolic Syndrome | Cardiovascular Risk FactorSerbia
-
The George Institute for Global Health, ChinaNingxia Medical UniversityCompletedCardiovascular Diseases | DyslipidemiasChina
-
National Research Council, SpainIMDEA Food; CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain); IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)CompletedGenotype, Metabotype and Dietary HabitsSpain
-
University of California, DavisCalifornia Walnut CommissionCompletedImmune Function | Cardiovascular HealthUnited States
-
UConn HealthNational Cancer Institute (NCI); National Institutes of Health (NIH); University... and other collaboratorsRecruiting
-
Sophie Bucher Della TorreUniversity Hospital, GenevaActive, not recruiting
-
UConn HealthCalifornia Walnut Commission; American Institute for Cancer Research; The Jackson...CompletedColon Cancer | Colo-rectal Cancer | Diet HabitUnited States
-
University of California, San FranciscoCompletedPreDiabetes | Overweight and ObesityUnited States
-
Ludwig-Maximilians - University of MunichCompleted
-
Christos MantzorosCalifornia Walnut CommissionCompletedCardiovascular Disease | Metabolic Syndrome | Type 2 DiabetesUnited States