NCT05413928

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes
• Type 2 Diabetes
• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Time Restrictive Eating- late	Eating window will be 10 hours or less, starting 3 hours after waking up. Same monitoring as Baseline phase.
BEHAVIORAL	Time Restrictive Eating- early	Eating window will be 10 hours or less, starting 30 min after waking up. Same monitoring as Baseline phase.
BEHAVIORAL	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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-06-10
• Last updated: 2024-12-02

Locations

1 site across 1 country: United States