Clinical trial NCT05413928: Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
Official title: Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Type 2 Diabetes
Healthy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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 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.

Primary outcomes:
measure: Change in glycemic control as measured by change in blood sugar values.
timeFrame: 5 months
measure: Core body temperature response to meal consumption
timeFrame: Analysis of response to all standard meals will take 9 days
Secondary outcomes:
measure: Change in sleep quality measured as duration of sleep stages
timeFrame: 5 months
measure: Change in sleep quality measured as frequency of sleep stages
timeFrame: 5 months
measure: Change in wake duration during sleep
timeFrame: 5 months
measure: Sleep efficiency
timeFrame: 5 months
measure: Sleep latency
timeFrame: 5 months
measure: Heart rate response to meal consumption
timeFrame: Analysis of response to all standard meals will take 9 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Heyjun Park, PhD
role: STUDY_DIRECTOR
References: