Image

Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep

Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.

Description

Pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. The investigators are interested in understanding the effect of caloric distribution through the day, specifically consuming more later in the day versus earlier in the day. The investigators want to test the hypothesis that consolidating the meals during a shorter span in the day (time restricted eating) can ameliorate blood sugars and sleep parameters in the studied population. The researchers would also like to compare dynamic range of meal-induced sympathetic responses (e.g. temperature and heart rate changes) between different metabolic health conditions (e.g. insulin sensitive vs insulin resistant vs diabetes) while controlling for dietary intake. Previous research studies suggest that people with different metabolic health conditions would have different meal-induced sympathetic responses. Based on this, the primary goal of the study is to characterize metabolic health based on non-invasive wearable sensor data that measure these responses.

Eligibility

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.

Study details
    PreDiabetes
    Type 2 Diabetes
    Healthy

NCT05413928

Stanford University

1 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.