NCT01505140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

December 31, 2011

Last Update Submit

November 23, 2016

Conditions

InfertilityNutrition Disorders

Keywords

AndrologyFertilityReproductionDietNutritional SciencesFatty AcidsAntioxidantsBody weight changes

Outcome Measures

Primary Outcomes (5)

  • change from baseline in semen quality 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

    change from baseline at 12 weeks

  • change from baseline in serum selenium at 12 weeks

    change from baseline at 12 weeks

  • change from baseline in serum folate at 12 weeks

    change from baseline at 12 weeks

  • change from baseline in serum zinc at 12 weeks

    change from baseline at 12 weeks

Secondary Outcomes (2)

  • change from baseline in body weight pounds at 12 weeks

    change from baseline at 12 weeks

  • change from baseline in nutrient intake at 12 weeks

    change from baseline at 12 weeks

Study Arms (2)

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

Other: Whole walnuts

Interventions

Whole walnutsOTHER

75 gm whole walnuts per day will be consumed with usual Western style diet

Whole walnuts

Eligibility Criteria

Age21 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095-6919, United States

Location

Related Publications (1)

  • 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.

    PMID: 22895856RESULT

MeSH Terms

Conditions

InfertilityNutrition DisordersBody Weight Changes

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wendie A Robbins, RN, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2011

First Posted

January 6, 2012

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

US(1)