Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
NCT ID: NCT05413928
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2023-02-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Intervention
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).
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.
Macronutrient-controlled meals
Meals with a determined amount of protein, carbohydrates, and fat.
Interventions
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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.
Macronutrient-controlled meals
Meals with a determined amount of protein, carbohydrates, and fat.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Heyjun Park
Protocol Director
Principal Investigators
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Michael Snyder, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Heyjun Park, PhD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Caroline Bejikian
Role: primary
Dalia Perelman, MS, RD, CDE
Role: backup
Other Identifiers
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61843
Identifier Type: -
Identifier Source: org_study_id