The Role of Walnut Consumption on Sleep Quality
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ClinicalTrials.gov Identifier: NCT04799821 |
Recruitment Status :
Completed
First Posted : March 16, 2021
Last Update Posted : November 29, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Diet Sleep | Other: Control Other: Walnut intake | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 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 |
Actual Primary Completion Date : | July 31, 2022 |
Actual Study Completion Date : | March 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Daily walnut consumption
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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
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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. |
- 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)
- 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
- 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)
- 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)
- 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
- 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
- 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)
- 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)
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
Spain | |
Torribera Campus, University of Barcelona | |
Santa Coloma de Gramenet, Barcelona, Spain, 08921 |
Principal Investigator: | Maria Izquierdo-Pulido, PhD | University of Barcelona |
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: | November 29, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to make IPD available. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sleep quality Walnuts Body composition Circadian rhythms |