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

NCT04990973 | Terminated Results

• 2 other identifiers: AAAT7042R35HL155670
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep

Keywords

Mediterranean diet; cardiovascular health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Urinary 6-sulfatoxymelatonin Level

  Change from baseline to 4 weeks

• Change in Tryptophan

  Change from baseline to 4 weeks

• Change in Kynurenine

  Change from baseline to 4 weeks

• Change in Serotonin

  Change from baseline to 4 weeks

Study Arms (2)

Mediterranean Diet and then AAD

EXPERIMENTAL

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); Behavioral: Mediterranean Diet

Average American Diet (AAD) and then Mediterranean Diet

EXPERIMENTAL

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); Behavioral: Mediterranean Diet

Interventions

Average American Diet (AAD) 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).

Average American Diet (AAD) and then Mediterranean Diet; Mediterranean Diet and then AAD

Mediterranean Diet 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; Mediterranean Diet and then AAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sleep \>6 hours/night
• Sleep complaints

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Marie-Pierre St-Onge
• Organization: Columbia University Irving Medical Center

ms2554@cumc.columbia.edu

212-305-9379

Study Officials

• Marie-Pierre St-Onge, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statistician and research technicians involved in data and sample analyses will be blind to intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Medicine

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 5, 2021
• Study Start: July 2, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon publication of main study outcomes.
• Access Criteria: Determined upon request.

Locations

US (1)