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

• Sponsor: Columbia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04990973
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep	Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Masking Description: Statistician and research technicians involved in data and sample analyses will be blind to intervention.
• Primary Purpose: Treatment
• Official Title: Influence of Diet on Sleep and Cardiovascular Risk
• Actual Study Start Date: Jul 2, 2021
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Score on the Pittsburgh Sleep Quality Index (PSQI) [Baseline and 4 weeks]

   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.

2. Arousal index [Change from baseline to 4 weeks]

   Arousal index will be actigraphy-derived.

3. Sleep fragmentation index [Change from baseline to 4 weeks]

   Sleep fragmentation index will be actigraphy-derived.

4. Sleep duration [Change from baseline to 4 weeks]

   Sleep duration will be actigraphy-derived.

Secondary Outcome Measures

1. Change in Urinary 6-sulfatoxymelatonin level [Change from baseline to 4 weeks]

   Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer.

2. Change in tryptophan [Change from baseline to 4 weeks]

   Tryptophan metabolism

3. Change in kynurenine [Change from baseline to 4 weeks]

   Tryptophan metabolism

4. Change in serotonin [Change from baseline to 4 weeks]

   Neurotransmitter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Sleep >6 hours/night

• Sleep complaints

Exclusion Criteria:

• Smoking

• Allergies to foods

• Inability to comply with study procedures

• Gastrointestinal disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT04990973
• Other Study ID Numbers: AAAT7042
• First Posted: Aug 5, 2021
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University: Mediterranean diet; cardiovascular health

Study Results

No Results Posted as of Apr 13, 2022