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Twice Daily Meal Timing for Prediabetes
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Waitlist Available
Led By Jill Crandall, MD
Research Sponsored by Albert Einstein College of Medicine
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 5 weeks
Awards & highlights
Study Summary
This trial is testing whether restricting eating periods to twice a day, as compared to eating whenever you want (ad lib), will have beneficial effects on things like glucose metabolism and body composition in human subjects at risk for diabetes.
Who is the study for?
Men aged 30-70 with prediabetes or untreated diabetes (HbA1c < 6.8%) and a BMI of 25-35 kg/m2 can join this study. They shouldn't be doing heavy exercise like marathons, have unstable weight, smoke, abuse substances, or have certain chronic illnesses or conditions affecting diet.Check my eligibility
What is being tested?
The trial is testing if eating twice a day has health benefits over eating anytime you want. Both groups eat the same calories but at different times. The focus is on how this affects blood sugar control, body fat, energy use, and cell cleaning processes in people at risk for diabetes.See study design
What are the potential side effects?
Since the interventions involve meal timing rather than medication, typical drug side effects are not expected. However, changes in diet patterns may cause temporary digestive discomfort or hunger outside of planned meal times.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin sensitivity
Secondary outcome measures
Autophagy level
Body Composition
Energy expenditure
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Twice a day meals firstExperimental Treatment2 Interventions
This arm will receive the twice a day feeding intervention first, followed by the ad libitum meal timing intervention.
Group II: Ad libitum meal timing firstExperimental Treatment2 Interventions
This arm will receive the ad libitum meal timing intervention first, followed by the twice a day feeding intervention.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,006 Total Patients Enrolled
Albert Einstein College of MedicineLead Sponsor
286 Previous Clinical Trials
11,856,921 Total Patients Enrolled
Jill Crandall, MDPrincipal InvestigatorAlbert Einstein College of Medicine
4 Previous Clinical Trials
2,833 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You regularly do very intense physical activities like running marathons or lifting heavy weights.You have type 2 diabetes and your A1C level is 6.8% or higher, or you are taking medication for it.Your weight has changed by more than 5 pounds or 2.5% of your body weight in the last 3 months.You currently smoke, abuse alcohol, or use drugs.You have Type 1 diabetes.Males between 30 and 70 years old.You have high blood sugar levels, but not high enough to be considered diabetes and you're not currently taking medication for it. Your HbA1c level is less than 6.8%.You are taking medications that affect how your body uses glucose, like diabetes medications or high-dose niacin.You have ongoing stomach or digestion problems, or need a special diet.Your weight is within a certain range based on your height.You have serious ongoing health issues like severe COPD, heart failure, kidney disease, liver problems, recent stroke, heart attack, cancer, or HIV under treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ad libitum meal timing first
- Group 2: Twice a day meals first
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.
What is the aggregate size of the participants in this research project?
"Affirmative. According to clinicaltrials.gov, this experiment is currently enrolling individuals and was first posted on June 20th 2019 with the most recent update made on February 3rd 2022. 25 volunteers are required from 1 location for this study."
Answered by AI
Are there opportunities for participation in this experiment currently available?
"According to clinicaltrials.gov, this experiment is actively searching for participants; it was initially posted on June 20th 2019 and revised as recently as February 3rd 2022."
Answered by AI
Does this research include participants aged 50 and above?
"The study is seeking participants aged 30 to 70. In contrast, 11 and 160 studies are available for those below 18 years old as well as above 65 respectively."
Answered by AI
Who meets the criteria to participate in this research initiative?
"This medical experiment is searching for 25 individuals with prediabetes, aged 30 to 70. Those who meet the enrollment criteria can apply to join this trial."
Answered by AI
Who else is applying?
What site did they apply to?
Albert Einstein College of Medicine of Yeshiva University
What portion of applicants met pre-screening criteria?
Met criteria
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