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Meal Timing Modification for Type 2 Diabetes

N/A
Recruiting
Led By Michael Snyder, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate
Be generally healthy (with no apparent symptoms at the time of enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Study Summary

This trial will help researchers understand how different meal times affect people with diabetes and prediabetes, in terms of blood sugar, metabolism, microbiome, and sleep physiology. Additionally, researchers will study how different meals affect a person's temperature and heart rate.

Who is the study for?
This trial is for adults over 18 with prediabetes or type 2 diabetes managed by diet or metformin. Participants should be generally healthy, not pregnant, and not on weight loss meds or special diets. They must understand the study and agree to its procedures.Check my eligibility
What is being tested?
The study examines how meal timing and composition affect blood sugar levels, metabolism, gut bacteria, body temperature, heart rate response, and sleep in people with prediabetes or type 2 diabetes.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include hunger at unusual times due to altered eating patterns and potential discomfort from monitoring devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prediabetes, diet-controlled diabetes, or type 2 diabetes managed with metformin.
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I feel healthy and have no symptoms.
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I am 18 years old or older.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glycemic control as measured by change in blood sugar values.
Core body temperature response to meal consumption
Secondary outcome measures
Change in sleep quality measured as duration of sleep stages
Change in sleep quality measured as frequency of sleep stages
Change in wake duration during sleep
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment4 Interventions
Participants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping).

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,389 Previous Clinical Trials
17,334,652 Total Patients Enrolled
Michael Snyder, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
40 Total Patients Enrolled
Heyjun Park, PhDStudy DirectorStanford University

Media Library

Macronutrient-controlled meals Clinical Trial Eligibility Overview. Trial Name: NCT05413928 — N/A
Healthy Subjects Research Study Groups: Intervention
Healthy Subjects Clinical Trial 2023: Macronutrient-controlled meals Highlights & Side Effects. Trial Name: NCT05413928 — N/A
Macronutrient-controlled meals 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413928 — N/A

Frequently Asked Questions

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

Is enrollment still open for those who wish to participate in this experiment?

"According to records found on clinicaltrials.gov, the initial posting for this trial was made on June 1st 2022 and the most recent update occurred a week later. While currently inactive, there are an abundance of other research initiatives enrolling volunteers at present."

Answered by AI

What is the main aim of this clinical experiment?

"This clinical trial has a main objective of measuring core body temperature response to meal consumption over the course of 5 months. The secondary outcomes include changes in sleep quality (measured via headband wearable device) including duration and frequency, as well as an assessment on sleep efficiency compared against baseline measurements."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Stanford University
Recent research and studies
clinicaltrials.govStudy
Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
Heyjun Park 2023. "Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05413928.
All > Prediabetes
~24 spots leftby Dec 2024
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