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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
75
Eating window will be 10 hours or less, starting 3 hours after waking up. Same monitoring as Baseline phase.
Eating window will be 10 hours or less, starting 30 min after waking up. Same monitoring as Baseline phase.
Same as TRE-early, but concentrating caloric intake early in the eating window Same monitoring as Baseline phase.
Stanford University
Stanford, California, United States
RECRUITINGChange 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
Time frame: 5 months
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.
Time frame: Analysis of response to all standard meals will take 9 days
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.
Time frame: 5 months
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.
Time frame: 5 months
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.
Time frame: 5 months
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.
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Meals with a determined amount of protein, carbohydrates, and fat.
Time frame: 5 months
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.
Time frame: 5 months
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).
Time frame: Analysis of response to all standard meals will take 9 days