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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413928
• Other study ID #: 61843
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Alessandra Celli, MS
• Phone: (650) 725-8491
• Email: alessandra.celli[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Healthy
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• Time Restrictive Eating- late
Eating window will be 10 hours or less, starting 3 hours after waking up. Same monitoring as Baseline phase.
• Time Restrictive Eating- early
Eating window will be 10 hours or less, starting 30 min after waking up. Same monitoring as Baseline phase.
• Time Restrictive Eating- early with early caloric intake
Same as TRE-early, but concentrating caloric intake early in the eating window Same monitoring as Baseline phase.

Other:
• Macronutrient-controlled meals
Meals with a determined amount of protein, carbohydrates, and fat.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycemic control as measured by change in blood sugar values.	Change in glycemic control measured from baseline through all phases of study. Glycemic control is derived from continuous glucose monitor (CGM) data and expressed in milligrams/deciliter	5 months
Primary	Core body temperature response to meal consumption	Analysis of core body temperature response as measured by change from overnight fasting condition to the peak value within 4 hrs following the standardized meal consumption. Core body temperature response is derived from CTM data and expressed in Celsius.	Analysis of response to all standard meals will take 9 days
Secondary	Change in sleep quality measured as duration of sleep stages	Duration of each sleep stage (i.e. light, deep, REM, wake stages) overnight. Sleep quality will be measured via a headband wearable device. Sleep quality will be compared to baseline through the other intervention phases.	5 months
Secondary	Change in sleep quality measured as frequency of sleep stages	Frequency of each sleep stage (i.e. light, deep, REM, wake stages) overnight. Sleep quality will be measured via a headband wearable device. Sleep quality will be compared to baseline through the other intervention phases.	5 months
Secondary	Change in wake duration during sleep	Measurement of Wake After Sleep Onset (WASO) in minutes. Measured via a headband wearable device. WASO will be compared to baseline through the other intervention phases.	5 months
Secondary	Sleep efficiency	Sleep efficiency will be calculated by the following formula: 100-((WASO/total sleep duration)x100).; Changes will be compared from baseline to the rest of the intervention phases.	5 months
Secondary	Sleep latency	Sleep latency is the duration in minutes from being awake to falling asleep. Changes in sleep latency will be compared from baseline to the rest of the intervention phases.	5 months
Secondary	Heart rate response to meal consumption	Heart rate response to meal consumption as measured by the change in heart rate from baseline (overnight fasting condition) to the peak value within 4 hrs following the standardized meal consumption. Heart rate response is derived from continuous heart rate monitoring (CHRM) data and expressed in beats per minute (bpm).	Analysis of response to all standard meals will take 9 days