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The Role of Walnut Consumption on Sleep Quality

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ClinicalTrials.gov Identifier: NCT04799821
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Dra. Maria Izquierdo-Pulido, University of Barcelona

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.

Condition or disease Intervention/treatment Phase
Healthy Diet Sleep Other: Control Other: Walnut intake Not Applicable

Detailed Description:
The study to investigate the effect of daily walnut consumption on sleep quality will be conducted in an 18-week randomized crossover trial, in which participants will be initially assigned to intervention or control conditions for 8-weeks. After 2 weeks of washout, subjects will be crossed over to the alternate intervention and will continue for another 8 weeks. Note that throughout the whole study, each participant will attend 5 visits: 1 initial visit (baseline) and 2 visits in each one of the study conditions (intervention and control).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Eat Walnuts and Sleep Better: Exploring the Potential Role of Walnuts as Sleep-promoting Food and Their Impact on Body Composition
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Intervention
Daily walnut consumption
Other: Walnut intake
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.

Control
No walnut consumption
Other: Control
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.




Primary Outcome Measures :
  1. Changes in sleep onset latency from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Weeks 4, 8, 14 and 18 ]
    Measured in hours of sleep with an actigraph (ActTrust, CONDOR, Brazil)

  2. Changes in sleep efficiency from baseline to weeks 4, 8, 14, and 18 [ Time Frame: 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


  3. Changes in wake after sleep onset (WASO) from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Week 4, 8, 14, and 18 ]
    Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil)

  4. Changes in sleep duration from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Weeks 4, 8, 14, and 18 ]
    Measured in hours of sleep time with an actigraph (ActTrust, CONDOR, Brazil)

  5. Changes in urinary 6-sulphaoxymelatonin from baseline to week 4, 8, 14 and 18 [ Time Frame: Week 4, 8, 14 and 18 ]
    Quantified using urine Melatonin-Sulfate ELISA kit


Secondary Outcome Measures :
  1. Changes in body mass index (BMI) from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Weeks 4, 8, 14 and 18 ]
    Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2

  2. Changes in body fat from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Weeks 4, 8, 14 and 18 ]
    Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea)

  3. Changes in weight circumference from baseline to weeks 4, 8, 14, and 18 [ Time Frame: Weeks 4, 8, 14 and 18 ]
    Measured midway between the lower rib margin and the iliac crest with the subject standing and wearing only underwear, at the end of gentle expiration with an anthropometric tape (CESCORF, Brazil)

  4. Changes in eating behavior from baseline to weeks 8 and 18 [ Time Frame: Weeks 8 and 18 ]

    To evaluate changes in eating behavior, the Spanish version of the Food Cravings Questionnaire will be used (Cepeda-Benito et al, 2000).

    This questionnaire evaluates 10 dimensions of eating behavior:

    • Having Intentions and Plans to Consume Food
    • Anticipation of Positive Reinforcement that may Result from Eating
    • Anticipation of Relief from Negative States and Feelings as a Result of Eating
    • Lack of Control over Eating
    • Thoughts or Preoccupation with Food
    • Having Intentions and Plans to Consume Food
    • Craving as a Physiological State
    • Emotions that may be Experienced Before or During Food Cravings or Eating
    • Cues that may Trigger Food Cravings
    • Guilt from Cravings and/or for Giving in to Them

    For each subscale, scores range from 0 to 5, with higher scores indicating a stronger sensation of craving.


  5. Changes in well-being from baseline to weeks 8 and 18 [ Time Frame: Weeks 8 and 18 ]

    Well-being will be measured with the Spanish version of the WHO-5 Well-being Index (Lucas-Carrasco et. al. 2012).

    Scores range from 0 to 100, with higher scores indicating higher well-being.




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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799821


Contacts
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Contact: Maria Izquierdo-Pulido, PhD +34661857879 maria_izquierdo@ub.edu
Contact: Maria F Zerón Rugerio, PhD +34697297623 fernanda.zeron@ub.edu

Locations
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Spain
Torribera Campus, University of Barcelona Recruiting
Santa Coloma de Gramenet, Barcelona, Spain, 08921
Contact: Maria Izquierdo-Pulido, PhD    +34661857879    maria_izquierdo@ub.edu   
Contact: Maria F Zerón-Rugerio, PhD    +34697297623    fernanda.zeron@ub.edu   
Sponsors and Collaborators
University of Barcelona
California Walnut Commission
Investigators
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Principal Investigator: Maria Izquierdo-Pulido, PhD University of Barcelona
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Responsible Party: Dra. Maria Izquierdo-Pulido, Full Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT04799821    
Other Study ID Numbers: 600269
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dra. Maria Izquierdo-Pulido, University of Barcelona:
Sleep quality
Walnuts
Body composition
Circadian rhythms