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

Influence of Diet on Sleep and Cardiovascular Risk

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

Study Overview

• Status: Terminated
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sleep >6 hours/night
• Sleep complaints

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Experimental: 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.	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).

What is the study measuring?

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.	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

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Mediterranean diet; cardiovascular health
• Other Study ID Numbers: AAAT7042; R35HL155670 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be shared upon request and review by investigators.
• IPD Sharing Time Frame: Upon publication of main study outcomes.
• IPD Sharing Access Criteria: Determined upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No