Impact of meal timing and composition on glucose metabolism and sleep
Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
This study is testing if changing when and what you eat can help people with prediabetes and type 2 diabetes manage their blood sugar better and sleep more soundly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05413928 on ClinicalTrials.gov |
What this trial studies
This study investigates how altering meal timing and composition affects blood sugar levels, metabolism, and sleep in individuals with prediabetes and type 2 diabetes. It aims to explore the effects of time-restricted eating and caloric distribution throughout the day on metabolic health and physiological responses such as body temperature and heart rate. Participants will be monitored using non-invasive wearable sensors to gather data on their metabolic responses to different meal patterns. The study seeks to determine whether consolidating meals into a shorter time frame can improve glucose management and sleep quality.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with prediabetes, diet-controlled type 2 diabetes, or those on metformin, who are generally healthy and willing to participate.
Not a fit: Patients with major organ diseases, pregnant or lactating women, and those on certain diabetes medications or with specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary strategies that improve glucose control and overall health for individuals with prediabetes and type 2 diabetes.
How similar studies have performed: Previous studies have suggested that meal timing and composition can significantly impact metabolic health, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be 18 years of age or older; * Not be pregnant, if female; * Be generally healthy (with no apparent symptoms at the time of enrollment) * Patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate. * Be willing to provide written informed consent for all study procedures. Exclusion Criteria: * major organ disease * pregnant/lactating * diabetes medications except for metformin * malabsorptive disorders like celiac sprue * heavy alcohol use * use of weight loss medications or specific diets * weight change \>2 Kg in the last month * history of bariatric surgery * Any medical condition that physicians believe would interfere with study participation or evaluation of results * Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael Snyder, PhD — Stanford University
- Study coordinator: Alessandra Celli, MS
- Email: alessandra.celli@stanford.edu
- Phone: (650) 725-8491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.