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| ID | Type | Description | Link |
|---|---|---|---|
| R35HL155670 | U.S. NIH Grant/Contract | View source |
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Pilot study; collection of information completed
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Average American Diet (AAD) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 weeks |
| Average Sleep Duration Per Night | Sleep duration will be actigraphy-derived. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary 6-sulfatoxymelatonin Level | Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer. | Change from baseline to 4 weeks |
| Change in Tryptophan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Will be shared upon request and review by investigators.
Upon publication of main study outcomes.
Determined upon request.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mediterranean Diet, Then Average American Diet | 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). |
| FG001 | Average American Diet, 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
| |||||||||||||
| Washout (4 Weeks) |
| |||||||||||||
| Second Intervention (4 Weeks) |
|
Baseline characteristics were only collected from participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 1 participant in the Mediterranean Diet condition did not complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
Study intervention timeframe (approximately 12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mediterranean Diet | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marie-Pierre St-Onge | Columbia University Irving Medical Center | 212-305-9379 | ms2554@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Aug 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Statistician and research technicians involved in data and sample analyses will be blind to intervention.
|
| Mediterranean Diet | Behavioral | 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). |
|
Tryptophan metabolism
| Change from baseline to 4 weeks |
| Change in Kynurenine | Tryptophan metabolism | Change from baseline to 4 weeks |
| Change in Serotonin | Neurotransmitter | Change from baseline to 4 weeks |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PSQI | Mean | Standard Deviation | units on a scale |
|
| 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. Two weeks prior to randomization, participants will wear an actigraph monitor and keep a sleep diary to verify sleep duration and quality. | Mean | Standard Deviation | percent |
|
| Sleep duration | Sleep duration reported as average amount of sleep (in minutes) per night. Two weeks prior to randomization, participants will wear an actigraph monitor and keep a sleep diary to verify sleep duration and quality. | Mean | Standard Deviation | minutes per night |
|
| OG001 | Average American Diet (AAD) Condition | 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). |
|
|
| 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. | Posted | Mean | Standard Deviation | percent | 4 weeks |
|
|
|
| Primary | Average Sleep Duration Per Night | Sleep duration will be actigraphy-derived. | Posted | Mean | Standard Deviation | minutes per night | 4 weeks |
|
|
|
| Secondary | Change in Urinary 6-sulfatoxymelatonin Level | Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer. | Due to study termination, data was not collected and therefore not analyzed. | Posted | Change from baseline to 4 weeks |
|
|
| Secondary | Change in Tryptophan | Tryptophan metabolism | Due to study termination, data was not collected and therefore not analyzed. | Posted | Change from baseline to 4 weeks |
|
|
| Secondary | Change in Kynurenine | Tryptophan metabolism | Due to study termination, data was not collected and therefore not analyzed. | Posted | Change from baseline to 4 weeks |
|
|
| Secondary | Change in Serotonin | Neurotransmitter | Due to study termination, data was not collected and therefore not analyzed. | Posted | Change from baseline to 4 weeks |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Average American Diet (AAD) | 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). | 0 | 4 | 0 | 4 | 0 | 4 |
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| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |