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Behavioral Intervention

Mediterranean Diet for Sleep

N/A
Waitlist Available
Led By Marie-Pierre St-Onge, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of diet on sleep and heart disease risk factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Sleep Duration Per Night
Score on the Pittsburgh Sleep Quality Index (PSQI)
Sleep Fragmentation Index
Secondary study objectives
Change in Kynurenine
Change in Serotonin
Change in Tryptophan
+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT04534738
4%
Shortness of breath
4%
Cellulitis of the chest wall
4%
Fainting
4%
Pneumonia
4%
Bacteremia
4%
Neutropenic fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mediterranean Diet
Usual Care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mediterranean Diet and then AADExperimental Treatment2 Interventions
Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
Group II: Average American Diet (AAD) and then Mediterranean DietExperimental Treatment2 Interventions
Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mediterranean Diet
2013
Completed Phase 4
~2550

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,918 Previous Clinical Trials
47,759,159 Total Patients Enrolled
33 Trials studying Sleep
57,145 Patients Enrolled for Sleep
Columbia UniversityLead Sponsor
1,483 Previous Clinical Trials
2,629,984 Total Patients Enrolled
10 Trials studying Sleep
515 Patients Enrolled for Sleep
Marie-Pierre St-Onge, PhDPrincipal Investigator - Columbia University
Columbia University
9 Previous Clinical Trials
461 Total Patients Enrolled
2 Trials studying Sleep
99 Patients Enrolled for Sleep
~3 spots leftby Oct 2025