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Strengthening Circadian Signals for Improving Cardiometabolic Outcomes in Adults

N/A

Recruiting

Led By Phyllis Zee, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will study the effects of meal timing and melatonin administration on cardiometabolic function in overweight and obese adults.

Who is the study for?

Adults aged 35-54 with a BMI of 25 to less than 45, regular sleep and eating schedules, an overnight fast of no more than 13 hours, and not suffering from severe medical conditions or taking certain medications. Excludes pregnant women, prisoners, those on recent weight loss programs or with sleep disorders.Check my eligibility

What is being tested?

The trial is testing if meal timing and/or low-dose melatonin (1 mg) can improve cardiometabolic function by strengthening circadian rhythms in overweight adults. It's a placebo-controlled study with four different intervention groups over six weeks.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to melatonin such as drowsiness or changes in sleep patterns. Meal timing interventions generally have minimal side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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

Matsuda Index

Melatonin Amplitude

Nocturnal Blood Pressure Dipping

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MelatoninExperimental Treatment2 Interventions

This arm will continue to eat at their habitual meal times, and maintain their average habitual caloric and macronutrient intake. No extended overnight fasting will be imposed. This arm will include a 1mg melatonin supplementation given daily during the intervention.

Group II: Meal timing + PlaceboExperimental Treatment2 Interventions

This arm will consist of imposing a minimum overnight fasting period of 12 hours and a maximum of 16 hours (with exception of water and other non-caloric beverages), beginning 3 hours before their habitual bed time. This arm will also include a melatonin placebo (lactose) supplementation given daily during the intervention.

Group III: Meal timing + MelatoninExperimental Treatment2 Interventions

This arm will consist of imposing a minimum overnight fasting period of 12 hours and a maximum of 16 hours (with exception of water and other non-caloric beverages), beginning 3 hours before their habitual bed time. This arm will also include a 1mg melatonin supplementation given daily during the intervention.

Group IV: PlaceboPlacebo Group2 Interventions

This arm will continue to eat at their habitual meal times, and maintain their average habitual caloric and macronutrient intake. No extended overnight fasting will be imposed. This arm will also include a melatonin placebo (lactose) supplementation given daily during the intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebos

2019

Completed Phase 4

~2030

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,026 Total Patients Enrolled

Phyllis Zee, MD, PhDPrincipal Investigator - Northwestern University

Northwestern Memorial Hospital

Finch U Of Hs/Chicago Medical Sch (Medical School)

Mc Gaw Mc/Northwestern University (Residency)

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Meal Timing Clinical Trial Eligibility Overview. Trial Name: NCT03490864 — N/A

Improving Cardiometabolic Outcomes in Adults Research Study Groups: Meal timing + Placebo, Meal timing + Melatonin, Melatonin, Placebo

Improving Cardiometabolic Outcomes in Adults Clinical Trial 2023: Meal Timing Highlights & Side Effects. Trial Name: NCT03490864 — N/A

Meal Timing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03490864 — N/A

Frequently Asked Questions

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

How many individuals have elected to participate in this experiment?

"Indeed, the data hosted on clinicaltrials.gov conveys that this medical study is actively recruiting patients. It was initially posted in May of 2018 and most recently revised on November 15th 2022; with a goal to enroll 100 people from 1 site."

Answered by AI

Is there still availability for participants in this investigation?

"That is correct. According to the information on clinicaltrials.gov, this medical trial has been active since May 16th 2018 and its last update was November 15th 2022. The experiment seeks out 100 participants from 1 designated site."

Answered by AI

Are adults aged 18 and above eligible to become participants in this research?

"According to the protocol laid out in this trial's eligibility criteria, potential participants must be aged between 35 and 54."

Answered by AI

Am I eligible to sign up for this medical experiment?

"The current study seeks to recruit 100 individuals aged 35-54 who have improved cardiometabolic outcomes. To be eligible, participants must also abide by a regular eating schedule with two meals daily and sleep patterns that include an overnight fast of 13 hours or less over three days and no more than nine hours in bed. Furthermore, the average self-reported duration of slumber should exceed 6.5 hours while habitual mid sleep time is best between 2am - 5am."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strengthening Circadian Signals

Phyllis Zee 2018. "Strengthening Circadian Signals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03490864.

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