Evaluation of Diet and Sleep in Vascular Health: A Pilot Study

Study Overview
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Brief Summary
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The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.

Detailed Description
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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.

Official Title
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Influence of Diet on Sleep and Cardiovascular Risk

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: Average American Diet (AAD)
* Behavioral: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep >6 hours/night Sleep complaints Exclusion Criteria: Smoking Allergies to foods Inability to comply with study procedures Gastrointestinal disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet and then AAD<br>Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD. | Behavioral: Average American Diet (AAD)<br>* 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).<br>Behavioral: Mediterranean Diet<br>* 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).<br>|
| Experimental: Average American Diet (AAD) and then Mediterranean Diet<br>Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet. | Behavioral: Average American Diet (AAD)<br>* 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).<br>Behavioral: Mediterranean Diet<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Baseline and 4 weeks | 
| Arousal index | Arousal index will be actigraphy-derived. | Change from baseline to 4 weeks | 
| Sleep fragmentation index | Sleep fragmentation index will be actigraphy-derived. | Change from baseline to 4 weeks | 
| Sleep duration | Sleep duration will be actigraphy-derived. | Change from baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean diet, cardiovascular health