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

Not Applicable

Terminated

• Conditions: Sleep
• Interventions: Behavioral: Average American Diet (AAD); Behavioral: Mediterranean Diet

• Registration Number: NCT04990973
• Lead Sponsor: Columbia University

Brief Summary

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

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 Timeline

• Study Start: 2021-07-02
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-05
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Results First Submitted: 2024-03-25
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Sleep >6 hours/night
• Sleep complaints

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet and then AAD	Mediterranean Diet	Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
Mediterranean Diet and then AAD	Average American Diet (AAD)	Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
Average American Diet (AAD) and then Mediterranean Diet	Mediterranean Diet	Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.
Average American Diet (AAD) and then Mediterranean Diet	Average American Diet (AAD)	Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.

Primary Outcome Measures

Name	Time	Method
Score on the Pittsburgh Sleep Quality Index (PSQI)	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.
Sleep Fragmentation Index	4 weeks	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.
Average Sleep Duration Per Night	4 weeks	Sleep duration will be actigraphy-derived.

Secondary Outcome Measures

Name	Time	Method
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.
Change in Tryptophan	Change from baseline to 4 weeks	Tryptophan metabolism
Change in Kynurenine	Change from baseline to 4 weeks	Tryptophan metabolism
Change in Serotonin	Change from baseline to 4 weeks	Neurotransmitter

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States