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

NCT04990973 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-10-17

Study results available
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Summary

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

Conditions

  • Sleep

Interventions

BEHAVIORAL

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).

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).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Marie-Pierre St-Onge, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04990973 on ClinicalTrials.gov