NCT04799821

Brief Summary

Walnuts have a unique nutritional profile, including the sleep-regulating hormone melatonin, tryptophan, and omega-3 fatty acids, the two latest nutrients involved in melatonin and serotonin synthesis. Although it has been claimed that walnuts may improve sleep, to the investigators' knowledge, no studies have been conducted to objectively determine the impact of walnut consumption on sleep and overall well-being. Therefore, this study aims to investigate the effect of daily walnut consumption on sleep parameters (such as quality and duration). Secondarily, it aims to investigate the impact of daily walnut consumption on body composition, eating behavior, and well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

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

February 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

February 12, 2021

Last Update Submit

November 28, 2023

Conditions

Healthy DietSleep

Keywords

Sleep qualityWalnutsBody compositionCircadian rhythms

Outcome Measures

Primary Outcomes (5)

  • Changes in sleep onset latency from baseline to weeks 4, 8, 14, and 18

    Measured in hours of sleep with an actigraph (ActTrust, CONDOR, Brazil)

    Weeks 4, 8, 14 and 18

  • Changes in sleep efficiency from baseline to weeks 4, 8, 14, and 18

    Calculated in percentage as the ratio of total sleep time (TST) to time in bed (TIB). Sleep efficiency (percent) = (TST/TIB)\*100

    Weeks 4, 8, 14 and 18

  • Changes in wake after sleep onset (WASO) from baseline to weeks 4, 8, 14, and 18

    Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil)

    Week 4, 8, 14, and 18

  • Changes in sleep duration from baseline to weeks 4, 8, 14, and 18

    Measured in hours of sleep time with an actigraph (ActTrust, CONDOR, Brazil)

    Weeks 4, 8, 14, and 18

  • Changes in urinary 6-sulphaoxymelatonin from baseline to week 4, 8, 14 and 18

    Quantified using urine Melatonin-Sulfate ELISA kit

    Week 4, 8, 14 and 18

Secondary Outcomes (5)

  • Changes in body mass index (BMI) from baseline to weeks 4, 8, 14, and 18

    Weeks 4, 8, 14 and 18

  • Changes in body fat from baseline to weeks 4, 8, 14, and 18

    Weeks 4, 8, 14 and 18

  • Changes in weight circumference from baseline to weeks 4, 8, 14, and 18

    Weeks 4, 8, 14 and 18

  • Changes in eating behavior from baseline to weeks 8 and 18

    Weeks 8 and 18

  • Changes in well-being from baseline to weeks 8 and 18

    Weeks 8 and 18

Study Arms (2)

Intervention

EXPERIMENTAL

Daily walnut consumption

Other: Walnut intake

Control

OTHER

No walnut consumption

Other: Control

Interventions

ControlOTHER

Participants will be asked to refrain from walnut intake and to follow an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Control
Walnut intakeOTHER

Participants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Intervention

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19-26 kg/m\^2
  • Habitual moderate exercise level
  • No recent history of weight change exceeding 2.3kg (5lb) within the prior 3 months.

You may not qualify if:

  • Nuts allergy
  • Any acute or chronic diseases
  • Smokers
  • Any drugs or supplementations
  • Any alimentary restrictions or specific diets
  • Being a shift or night workers
  • Being unable to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torribera Campus, University of Barcelona

Santa Coloma de Gramenet, Barcelona, 08921, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Maria Izquierdo-Pulido, PhD

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

February 12, 2021

First Posted

March 16, 2021

Study Start

February 1, 2021

Primary Completion

July 31, 2022

Study Completion

March 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available.

Locations

ES(1)