InfertilityPhase 2NCT01505140
Benefits of Walnuts for Male Reproductive Health
A Phase 2 study testing Whole walnuts in people with Infertility and Nutrition Disorders, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Nutrition Disorders
- What is being tested?
- Whole walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095-6919
About this study
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.
Read the 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.
- Conditions
- Infertility, Nutrition Disorders
- Being tested
- Whole walnuts
- Keywords
- Andrology, Fertility, Reproduction, Diet, Nutritional Sciences, Fatty Acids, Antioxidants, Body weight changes
- Medical subject headings
- Infertility, Nutrition Disorders, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole walnutsOther
75 gm whole walnuts per day will be consumed with usual Western style diet
| Study group | Role | What they receive |
|---|---|---|
| Usual Western style diet | No intervention | Participants will consume their usual Western style diet avoiding tree nuts |
| Whole walnuts | Experimental | Participants will consume usual Western style diet adding 75 gm whole walnuts per day Receives: Other: Whole walnuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in semen quality at 12 weeks
semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
Measured: change from baseline at 12 weeks
change from baseline in serum fatty acids at 12 weeks
Measured: change from baseline at 12 weeks
change from baseline in serum selenium at 12 weeks
Measured: change from baseline at 12 weeks
change from baseline in serum folate at 12 weeks
Measured: change from baseline at 12 weeks
change from baseline in serum zinc at 12 weeks
Measured: change from baseline at 12 weeks
Secondary outcomes (2)
change from baseline in body weight pounds at 12 weeks
Measured: change from baseline at 12 weeks
change from baseline in nutrient intake at 12 weeks
Measured: change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Sponsor
- Investigators
- Wendie A Robbins, RN, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505140
- Sponsor's protocol ID
- 445246WR77518
- Status last verified
- Nov 2016
- First submitted
- 31 Dec 2011
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22895856
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Walnuts for Male Reproductive Health
- ClinicalTrials.gov ID
- NCT01505140
- Acronym / sponsor ID
- 445246WR77518
- Conditions
- Infertility, Nutrition Disorders
- Keywords
- Andrology, Fertility, Reproduction, Diet, Nutritional Sciences, Fatty Acids, Antioxidants, Body weight changes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Western style diet | No intervention | –Participants will consume their usual Western style diet avoiding tree nuts |
| Whole walnuts | Experimental | Other: Whole walnutsParticipants will consume usual Western style diet adding 75 gm whole walnuts per day |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole walnuts75 gm whole walnuts per day will be consumed with usual Western style diet | Other | Whole walnuts |
Primary outcome
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 in serum fatty acids at 12 weeks
Time frame: 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 in serum folate at 12 weeks
Time frame: change from baseline at 12 weeks
change from baseline in serum zinc at 12 weeks
Time frame: change from baseline at 12 weeks
2 secondary outcomes
change from baseline in body weight pounds at 12 weeks
Time frame: change from baseline at 12 weeks
change from baseline in nutrient intake at 12 weeks
Time frame: change from baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Results publication: PubMed 22895856Robbins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendie A Robbins, RN, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole walnuts in people with Infertility and Nutrition Disorders, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in semen quality at 12 weeks (time frame: change from baseline at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.