SleepNCT04990973
Evaluation of Diet and Sleep in Vascular Health: A Pilot Study
A study testing Average American Diet (AAD) and Mediterranean Diet in people with Sleep, run by Columbia University at 1 site in United States.
Trial summary
The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Average American Diet (AAD) and Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sleep >6 hours/night
- Sleep complaints
Who cannot join
- Smoking
- Allergies to foods
- Inability to comply with study procedures
- Gastrointestinal disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Influence of Diet on Sleep and Cardiovascular Risk
The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.
Read the detailed description
Poor sleep quality is highly prevalent in adults in the U.S. and worldwide. Recent work suggests that dietary intakes may influence sleep. This mechanistic study will test whether consuming a healthy, Mediterranean diet will improve sleep quality in U.S. adults with poor sleep and lead to better cardiovascular disease risk profile. Given the relationship between sleep and cardiovascular health, improving sleep quality through dietary measures could contribute to improving health in adults.
- Conditions
- Sleep
- Being tested
- Average American Diet (AAD), Mediterranean Diet
- Keywords
- Mediterranean diet, cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Average American Diet (AAD)Behavioural
Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
Mediterranean DietBehavioural
Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet and then AAD | Experimental | Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD. Receives: Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet |
| Average American Diet (AAD) and then Mediterranean Diet | Experimental | Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet. Receives: Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Pittsburgh Sleep Quality Index (PSQI)
The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with >5 indicating poor sleep quality so a lower score is a better outcome.
Measured: 4 weeks
Sleep Fragmentation Index
Sleep Fragmentation is an index of restlessness during the sleep period expressed as a percentage (0 to 100%). The higher the index, the more sleep is disrupted.
Measured: 4 weeks
Average Sleep Duration Per Night
Sleep duration will be actigraphy-derived.
Measured: 4 weeks
Secondary outcomes (4)
Change in Urinary 6-sulfatoxymelatonin Level
Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer.
Measured: Change from baseline to 4 weeks
Change in Tryptophan
Tryptophan metabolism
Measured: Change from baseline to 4 weeks
Change in Kynurenine
Tryptophan metabolism
Measured: Change from baseline to 4 weeks
Change in Serotonin
Neurotransmitter
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start2 Jul 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Why it stopped: Pilot study; collection of information completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990973
- Sponsor's protocol ID
- AAAT7042
- Other IDs
- R35HL155670
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared upon request and review by investigators.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diet on Sleep and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT04990973
- Acronym / sponsor ID
- AAAT7042
- Conditions
- Sleep
- Keywords
- Mediterranean diet, cardiovascular health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pilot study; collection of information completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.
Detailed description
Poor sleep quality is highly prevalent in adults in the U.S. and worldwide. Recent work suggests that dietary intakes may influence sleep. This mechanistic study will test whether consuming a healthy, Mediterranean diet will improve sleep quality in U.S. adults with poor sleep and lead to better cardiovascular disease risk profile. Given the relationship between sleep and cardiovascular health, improving sleep quality through dietary measures could contribute to improving health in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet and then AAD | Experimental | Behavioral: Average American Diet (AAD), Behavioral: Mediterranean DietHealthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD. |
| Average American Diet (AAD) and then Mediterranean Diet | Experimental | Behavioral: Average American Diet (AAD), Behavioral: Mediterranean DietHealthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sleep >6 hours/night
- Sleep complaints
Key exclusion criteria (4 listed)
- Smoking
- Allergies to foods
- Inability to comply with study procedures
- Gastrointestinal disorders
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 |
|---|---|---|
| Average American Diet (AAD)Participants will follow specified diet requirements. Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet). | Behavioural | Average American Diet (AAD) and then Mediterranean Diet, Mediterranean Diet and then AAD |
| Mediterranean DietParticipants will follow specified diet requirements. Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet). | Behavioural | Average American Diet (AAD) and then Mediterranean Diet, Mediterranean Diet and then AAD |
Primary outcome
Score on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with >5 indicating poor sleep quality so a lower score is a better outcome.
Sleep Fragmentation Index
Time frame: 4 weeks
Sleep Fragmentation is an index of restlessness during the sleep period expressed as a percentage (0 to 100%). The higher the index, the more sleep is disrupted.
Average Sleep Duration Per Night
Time frame: 4 weeks
Sleep duration will be actigraphy-derived.
4 secondary outcomes
Change in Urinary 6-sulfatoxymelatonin Level
Time frame: Change from baseline to 4 weeks
Change in Tryptophan
Time frame: Change from baseline to 4 weeks
Change in Kynurenine
Time frame: Change from baseline to 4 weeks
Change in Serotonin
Time frame: Change from baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will be shared upon request and review by investigators.
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Healthy Adult Participants
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.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Average American Diet (AAD) and Mediterranean Diet in people with Sleep, run by Columbia University at 1 site in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Oct 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score on the Pittsburgh Sleep Quality Index (PSQI) (time frame: 4 weeks). The study lists 3 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 17 Oct 2024.