Healthy DietNCT04799821
The Role of Walnut Consumption on Sleep Quality
A study testing Walnut intake in people with Healthy Diet and Sleep, run by University of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Sleep
- What is being tested?
- Walnut intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Torribera Campus, University of Barcelona
Santa Coloma de Gramenet, Barcelona, 08921
About this study
Official title: Eat Walnuts and Sleep Better: Exploring the Potential Role of Walnuts as Sleep-promoting Food and Their Impact on Body Composition
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.
Read the 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).
- Conditions
- Healthy Diet, Sleep
- Being tested
- Control, Walnut intake
- Keywords
- Sleep quality, Walnuts, Body composition, Circadian rhythms
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily walnut consumption Receives: Other: Walnut intake |
| Control | Other | No walnut consumption Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Week 4, 8, 14 and 18
Secondary outcomes (5)
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
Measured: Weeks 4, 8, 14 and 18
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)
Measured: Weeks 4, 8, 14 and 18
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)
Measured: Weeks 4, 8, 14 and 18
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.
Measured: Weeks 8 and 18
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.
Measured: Weeks 8 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Feb 2021
- Primary completion31 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Dra. Maria Izquierdo-Pulido, University of Barcelona
- Investigators
- Maria Izquierdo-Pulido, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799821
- Sponsor's protocol ID
- 600269
- Status last verified
- Nov 2023
- First submitted
- 12 Feb 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Walnuts and Sleep Better: Exploring the Potential Role of Walnuts as Sleep-promoting Food and Their Impact on Body Composition
- ClinicalTrials.gov ID
- NCT04799821
- Acronym / sponsor ID
- 600269
- Conditions
- Healthy Diet, Sleep
- Keywords
- Sleep quality, Walnuts, Body composition, Circadian rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Walnut intakeDaily walnut consumption |
| Control | Other | Other: ControlNo walnut consumption |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Nuts allergy
- Any acute or chronic diseases
- Smokers
- Any drugs or supplementations
- Any alimentary restrictions or specific diets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants 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. | Other | Control |
| Walnut intakeParticipants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern. | Other | Intervention |
Primary outcome
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
5 secondary outcomes
Changes in body mass index (BMI) from baseline to weeks 4, 8, 14, and 18
Time frame: Weeks 4, 8, 14 and 18
Changes in body fat from baseline to weeks 4, 8, 14, and 18
Time frame: Weeks 4, 8, 14 and 18
Changes in weight circumference from baseline to weeks 4, 8, 14, and 18
Time frame: Weeks 4, 8, 14 and 18
Changes in eating behavior from baseline to weeks 8 and 18
Time frame: Weeks 8 and 18
Changes in well-being from baseline to weeks 8 and 18
Time frame: Weeks 8 and 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
Related trials for Healthy Diet
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Izquierdo-Pulido, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut intake in people with Healthy Diet and Sleep, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep onset latency from baseline to weeks 4, 8, 14, and 18 (time frame: Weeks 4, 8, 14 and 18). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.