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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-02

Study Completion Date

2022-10-28

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.

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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.

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Statistician and research technicians involved in data and sample analyses will be blind to intervention.

Study Groups

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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.

Group Type EXPERIMENTAL

Average American Diet (AAD)

Intervention Type 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).

Mediterranean Diet

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Average American Diet (AAD)

Intervention Type 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).

Mediterranean Diet

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL