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

Columbia University

Status: Terminated

Conditions: Sleep

Treatments: Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04990973

R35HL155670 (U.S. NIH Grant/Contract)

AAAT7042

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sleep >6 hours/night
• Sleep complaints

Exclusion criteria

• Smoking
• Allergies to foods
• Inability to comply with study procedures
• Gastrointestinal disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Mediterranean Diet and then AAD

Experimental group

Description:

Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.

Treatment:

Behavioral: Mediterranean Diet

Behavioral: Average American Diet (AAD)

Average American Diet (AAD) and then Mediterranean Diet

Experimental group

Description:

Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.

Treatment:

Behavioral: Mediterranean Diet

Behavioral: Average American Diet (AAD)