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

Sleep Clinical Trial

Official title:

Influence of Diet on Sleep and Cardiovascular Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04990973
• Other study ID #: AAAT7042
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Sleep >6 hours/night
• Sleep complaints

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Sleep

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 weeks
Primary	Arousal index	Arousal index will be actigraphy-derived.	Change from baseline to 4 weeks
Primary	Sleep fragmentation index	Sleep fragmentation index will be actigraphy-derived.	Change from baseline to 4 weeks
Primary	Sleep duration	Sleep duration will be actigraphy-derived.	Change from baseline to 4 weeks
Secondary	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
Secondary	Change in tryptophan	Tryptophan metabolism	Change from baseline to 4 weeks
Secondary	Change in kynurenine	Tryptophan metabolism	Change from baseline to 4 weeks
Secondary	Change in serotonin	Neurotransmitter	Change from baseline to 4 weeks