Sleep Clinical Trial
Official title:
Eat Walnuts and Sleep Better: Exploring the Potential Role of Walnuts as Sleep-promoting Food and Their Impact on Body Composition
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 |
Verified date | November 2023 |
Source | University of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Torribera Campus, University of Barcelona | Santa Coloma de Gramenet | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona | California Walnut Commission |
Spain,
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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