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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04799821
Other study ID # 600269
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date March 31, 2023

Study information

Verified date November 2023
Source University of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 31, 2023
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain Torribera Campus, University of Barcelona Santa Coloma de Gramenet Barcelona

Sponsors (2)

Lead Sponsor Collaborator
University of Barcelona California Walnut Commission

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Changes in body mass index (BMI) from baseline to weeks 4, 8, 14, and 18 Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2 Weeks 4, 8, 14 and 18
Secondary Changes in body fat from baseline to weeks 4, 8, 14, and 18 Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea) Weeks 4, 8, 14 and 18
Secondary Changes in weight circumference from baseline to 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) Weeks 4, 8, 14 and 18
Secondary Changes in eating behavior from baseline to 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.
Weeks 8 and 18
Secondary Changes in well-being from baseline to 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.
Weeks 8 and 18
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