Can Food Timing Reduce Your Diabetes Risk?

Study Overview
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Brief Summary
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The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants. Participants will: complete 2 inpatient stays be provided with test meals have frequent blood draws

Detailed Description
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The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Official Title
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Can Food Timing Reduce Your Diabetes Risk?

Conditions
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Dietary Habits

Intervention / Treatment
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* Behavioral: Day shift protocol - Diet order A-B
* Behavioral: Day shift protocol - Diet order B-A
* Behavioral: Night shift protocol - Diet order A-B
* Behavioral: Night shift protocol - Diet order B-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy with no acute or chronic medical and psychiatric disorders BMI 25.0-34.9 kg/m2 Exclusion Criteria: Smokers, current tobacco or e-cigarette use Drug or alcohol dependency Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day shift protocol with diet A<br>Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. | Behavioral: Day shift protocol - Diet order A-B<br>* Research participants will be assigned to day shift condition and Diet A-B order condition.<br>Behavioral: Day shift protocol - Diet order B-A<br>* Research participants will be assigned to day shift condition and Diet B-A order condition.<br>|
| Experimental: Day shift protocol with diet B<br>Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. | Behavioral: Day shift protocol - Diet order A-B<br>* Research participants will be assigned to day shift condition and Diet A-B order condition.<br>Behavioral: Day shift protocol - Diet order B-A<br>* Research participants will be assigned to day shift condition and Diet B-A order condition.<br>|
| Experimental: Night shift protocol with diet A<br>Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. | Behavioral: Night shift protocol - Diet order A-B<br>* Research participants will be assigned to simulated night shift condition and Diet A-B order condition.<br>Behavioral: Night shift protocol - Diet order B-A<br>* Research participants will be assigned to simulated night shift condition and Diet B-A order condition.<br>|
| Experimental: Night shift protocol with diet B<br>Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. | Behavioral: Night shift protocol - Diet order A-B<br>* Research participants will be assigned to simulated night shift condition and Diet A-B order condition.<br>Behavioral: Night shift protocol - Diet order B-A<br>* Research participants will be assigned to simulated night shift condition and Diet B-A order condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in glucose tolerance between Meal Conditions and Shift Work | Glucose incremental area under the curve (AUC) from mixed meal tests | 24 hours | 
| Difference in diet-induced thermogenesis between Meal Conditions and Shift Work | Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests | 24 hours | 
| Difference in plasma triglyceride level between Meal Conditions and Shift Work | Triglyceride area under the curve (AUC) over 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in insulin sensitivity between Meal Conditions and Shift Work | Insulin sensitivity index derived from Oral Minimal Model | 24 hours | 
| Difference in beta-cell function between Meal Conditions and Shift Work | Beta-cell function index derived from Oral Minimal Model | 24 hours | 
| Difference in 24-h glycemia between Meal Conditions and Shift Work | Glucose area under the curve (AUC) based on CGM over 24 hours | 24 hours | 
| Difference in postprandial incretin level between Meal Conditions and Shift Work | Incretin incremental area under the curve (AUC) from mixed meal tests | 24 hours | 
| Difference in substrate oxidation between Meal Conditions and Shift Work | Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests | 24 hours | 
| Difference in plasma free fatty acids level between Meal Conditions and Shift Work | Free fatty acids area under the curve (AUC) over 24 hours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose tolerance, Diet-induced thermogenesis