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

Stanford University

Status: Enrolling

Conditions: Healthy; Type 2 Diabetes; PreDiabetes

Treatments: Behavioral: Time Restrictive Eating- early with early caloric intake; Behavioral: Time Restrictive Eating- late; Behavioral: Time Restrictive Eating- early; Other: Macronutrient-controlled meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05413928

61843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Intervention

Experimental group

Description:

Participants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping).

Treatment:

Other: Macronutrient-controlled meals

Behavioral: Time Restrictive Eating- early

Behavioral: Time Restrictive Eating- early with early caloric intake

Behavioral: Time Restrictive Eating- late