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Early Total Caloric Intake for Cardiovascular Disease
N/A
Waitlist Available
Led By Eve Van Cauter, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
aged 30-75 years
Healthy overweight and obese (25 kg/m2 ≤BMI< 40 kg/m2) men and women aged 30-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days
Awards & highlights
Study Summary
This trial will study how the timing of meals affects metabolism and if metabolism changes with age.
Who is the study for?
This trial is for healthy overweight or obese adults aged 30-75 with a BMI between 25 and less than 40, who sleep between 6.5 to 9 hours nightly within specific hours. Excluded are those with dietary restrictions, certain blood conditions, diabetes, unstable medical issues, recent surgeries or clinical study participation, menopause or pregnancy in women, and various medication uses.Check my eligibility
What is being tested?
The study investigates how eating times affect body metabolism and energy use. Participants will follow different schedules of caloric intake: early total intake versus late intake and an extended overnight fast to see if these factors influence metabolic changes as people age.See study design
What are the potential side effects?
Since the interventions involve meal timing rather than medications or invasive procedures, side effects may include hunger at unusual times of day or discomfort from changing usual eating patterns but are not expected to be severe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 75 years old.
Select...
I am between 30 and 75 years old with a BMI between 25 and 40.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MI-IS
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Late Total Caloric IntakeExperimental Treatment1 Intervention
The Late Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 40% of daily calories during breakfast and lunch. The remaining 60% of daily calories will be consumed during dinner. This is a model for late dietary chronotype.
Group II: Early Total Caloric IntakeExperimental Treatment1 Intervention
The Early Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 60% of their daily calories during breakfast. The remaining 40% of daily calories will be consumed during lunch and dinner. This is a model for early dietary chronotype.
Group III: Extended Overnight FastActive Control1 Intervention
The extended overnight fast group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session. Subjects will consume approximately 33% of their daily calories at breakfast, lunch and dinner, respectively. This is a model for fasting dietary chronotype.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,498 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,661 Previous Clinical Trials
28,004,928 Total Patients Enrolled
Northwestern UniversityOTHER
1,580 Previous Clinical Trials
916,625 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a gastrointestinal (GI) disease that requires you to make changes to your diet.My hemoglobin level is above 11.5g/dL if female, or above 13.5g/dL if male.You have a history of brain-related disorders or problems with thinking and memory.I have a hormone-related condition like PCOS.My BMI is between 25 and 40, and I am considered overweight or obese but otherwise healthy.I am not currently going through menopause.I am unable to give consent by myself.I have a diagnosed sleep disorder like severe sleep apnea or a circadian rhythm issue.I have been in a weight loss program under medical supervision in the last year.You have a serious mental health condition according to the DSM-V guidelines.I do not have any serious or unstable health conditions.I haven't used melatonin, psychoactive drugs, stimulants, or smoked heavily in the past month.You sleep for at least 6.5 hours but no more than 9 hours each night, between 9:00 PM and 9:00 AM.I have been diagnosed with diabetes.I haven't had surgery, donated blood, worked night shifts, traveled across time zones, or joined another study in the last month.I am between 30 and 75 years old.I am between 30 and 75 years old with a BMI between 25 and 40.You should sleep for at least 6.5 hours but no more than 9 hours each night, between 9:00 PM and 9:00 AM.I have had weight loss surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Late Total Caloric Intake
- Group 2: Early Total Caloric Intake
- Group 3: Extended Overnight Fast
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research participants are currently enrolled in this project?
"Affirmative. Data hosted on clinicaltrials.gov shows that this research study, which was originally posted on February 2nd 2018, is actively searching for participants. It requires about 200 people to be enrolled at one medical facility."
Answered by AI
Are those over the age of 74 excluded from participating in this research initiative?
"The cut-off for this investigation mandates that participants be at least 30 years old and not above 75."
Answered by AI
Is enrollment for this trial ongoing at the present moment?
"According to clinicaltrials.gov, this research effort is still recruiting participants from the initial posting date of February 2nd 2018 and its latest update on January 27th 2022."
Answered by AI
To whom is the opportunity for this clinical investigation available?
"This cardiovascular study is recruiting 200 participants, aged 30-75 years old, who are classified as either overweight or obese (25 kg/m2 ≤BMI< 40 kg/m2). Participants must also report sleeping for between 6.5 and 9 hours nightly between the times of 21:00 to 09:00; signed informed consent is mandatory for admission into this trial."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
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