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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 baseline and 4 weeks
Awards & highlights

Study Summary

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

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arousal index
Score on the Pittsburgh Sleep Quality Index (PSQI)
Sleep duration
+1 more
Secondary outcome measures
Change in Urinary 6-sulfatoxymelatonin level
Change in kynurenine
Change in serotonin
+1 more

Side effects data

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

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
~2350

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,829 Total Patients Enrolled
9 Trials studying Sleep
455 Patients Enrolled for Sleep
Marie-Pierre St-Onge, PhDPrincipal Investigator - Columbia University
Columbia University
8 Previous Clinical Trials
437 Total Patients Enrolled
2 Trials studying Sleep
99 Patients Enrolled for Sleep

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants enrolled in this research?

"Indeed, the clinicaltrials.gov page indicates that recruitment is ongoing for this medical experiment. Initially posted on July 2nd 2021 and updated as recently as April 6th 2022, 10 participants need to be enrolled from a single site."

Answered by AI

Is the patient age-limit for this clinical trial higher than 85 years?

"To be eligible for this trial, patients must have attained the age of majority and not yet reached retirement."

Answered by AI

Is recruitment for this experiment open?

"Clinicaltrials.gov has the most up-to-date information on this trial's progress: it was posted in July 2021 and had its final update in April 2022, at which point enrolment became available to suitable patients."

Answered by AI

Does my profile satisfy the criteria for joining this research trial?

"To be eligible for this trial, interested parties must demonstrate sufficient restful sleep and meet the age criteria of 18 to 65. Approximately ten participants are being accepted."

Answered by AI

What is the primary goal of this research endeavor?

"The main outcome of this study, observed between Baseline and 4 weeks post-treatment, is the Arousal Index. Secondary goals include assessing changes in Tryptophan metabolism (Kynurenine), Urinary 6-sulfatoxymelatonin levels using competitive ELISA, and Neurotransmitter Serotonin."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Diet and Sleep in Vascular Health: A Pilot Study
Marie-Pierre St-Onge 2021. "Evaluation of Diet and Sleep in Vascular Health: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990973.
~1 spots leftby Apr 2025
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