Sleep
Conditions
Keywords
Mediterranean diet, cardiovascular health
Brief summary
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.
Interventions
BEHAVIORALAverage 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).
BEHAVIORALMediterranean Diet
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).
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Statistician and research technicians involved in data and sample analyses will be blind to intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Sleep \>6 hours/night * Sleep complaints
Exclusion criteria
* Smoking * Allergies to foods * Inability to comply with study procedures * Gastrointestinal disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Pittsburgh Sleep Quality Index (PSQI) | 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 | 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 | 4 weeks | Sleep duration will be actigraphy-derived. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary 6-sulfatoxymelatonin Level | Change from baseline to 4 weeks | Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer. |
| Change in Serotonin | Change from baseline to 4 weeks | Neurotransmitter |
| Change in Tryptophan | Change from baseline to 4 weeks | Tryptophan metabolism |
| Change in Kynurenine | Change from baseline to 4 weeks | Tryptophan metabolism |
Countries
United States
Participant flow
Pre-assignment details
11 individuals signed a consent form prior to screening assessments. Of those, 4 participants passed the eligibility criteria and were randomized to a study condition and participated in the study activities.
Participants by arm
| Arm | Count |
|---|---|
| Mediterranean Diet and Then AAD Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
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).
Mediterranean Diet: 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). | 2 |
| Average American Diet (AAD) and Then Mediterranean Diet Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.
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).
Mediterranean Diet: 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). | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Mediterranean Diet and Then AAD | Total | Average American Diet (AAD) and Then Mediterranean Diet |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 5.7 | 34.8 years STANDARD_DEVIATION 5.7 | 34.8 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PSQI | 3.5 units on a scale STANDARD_DEVIATION 0.7 | 4.3 units on a scale STANDARD_DEVIATION 1.3 | 5 units on a scale STANDARD_DEVIATION 1.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
| Sleep duration | 386.6 minutes per night STANDARD_DEVIATION 17 | 394.5 minutes per night STANDARD_DEVIATION 20.2 | 402.4 minutes per night STANDARD_DEVIATION 26.2 |
| Sleep Fragmentation Index | 29.9 percent STANDARD_DEVIATION 8.9 | 22.9 percent STANDARD_DEVIATION 10.1 | 15.9 percent STANDARD_DEVIATION 5.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Average Sleep Duration Per Night
Sleep duration will be actigraphy-derived.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet Condition | Average Sleep Duration Per Night | 403.7 minutes per night | Standard Deviation 52 |
| Average American Diet (AAD) Condition | Average Sleep Duration Per Night | 424.0 minutes per night | Standard Deviation 51.3 |
Primary
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.
Time frame: 4 weeks
Population: 1 participant in the Mediterranean Diet condition did not complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet Condition | Score on the Pittsburgh Sleep Quality Index (PSQI) | 0.3 units on a scale | Standard Deviation 1.5 |
| Average American Diet (AAD) Condition | Score on the Pittsburgh Sleep Quality Index (PSQI) | -0.5 units on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet Condition | Sleep Fragmentation Index | 11.0 percent | Standard Deviation 2.8 |
| Average American Diet (AAD) Condition | Sleep Fragmentation Index | 15.8 percent | Standard Deviation 8.4 |
Secondary
Change in Kynurenine
Tryptophan metabolism
Time frame: Change from baseline to 4 weeks
Population: Due to study termination, data was not collected and therefore not analyzed.
Secondary
Change in Serotonin
Neurotransmitter
Time frame: Change from baseline to 4 weeks
Population: Due to study termination, data was not collected and therefore not analyzed.
Secondary
Change in Tryptophan
Tryptophan metabolism
Time frame: Change from baseline to 4 weeks
Population: Due to study termination, data was not collected and therefore not analyzed.
Secondary
Change in Urinary 6-sulfatoxymelatonin Level
Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer.
Time frame: Change from baseline to 4 weeks
Population: Due to study termination, data was not collected and therefore not analyzed.