Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men

Study Overview
=================
Brief Summary
-----------------
Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be measured with the microdialysis technique by measuring glycerol concentration and blood flow in abdominal adipose tissue. Morning fat oxidation will be measured with indirect calorimetry. The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize that casein and placebo will not be significantly different from each other in terms of overnight lipolysis.

Official Title
-----------------
The Effect of Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Casein Protein
* Other: Non-caloric placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, sedentary overweight or obese (BMI ≥25 kg/m^2; body fat ≥ 25% ) men Exclusion Criteria: Men that have been exercising for more than 2 days per week for more than 45 minutes per session (within the past 6 months), have uncontrolled hypertension (Blood Pressure (BP)>160/100 mmHg, diagnosed cardiovascular disease, stroke, diabetes, thyroid or kidney dysfunction, take cholesterol medication, or have any allergies to milk products will be excluded. Smokers will also be excluded.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casein Protein<br>Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep | Other: Casein Protein<br>* The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined<br>|
| Placebo Comparator: Non-caloric Placebo<br>The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep | Other: Non-caloric placebo<br>* The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolysis | Measuring lipolysis using the microdialysis technique. Samples will be collected at various time intervals Vial 1: 30 minute; 2.0 uL/min flow rate Vial 2: 4 hours; 0.3 uL/min flow rate Vial 3: Overnight; 0.3 uL/min flow rate (before taking nighttime supplement) Vial 4: Morning sample #1; 2.0 uL/min flow rate (upon waking) Vial 5: Morning sample #2; 2.0 uL/min flow rate (arrive to lab) Blood flow will be measured using the Ethanol technique | Change from day 1 to day 2 to day 3 of testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate (RMR) | RMR will be measured with indirect calorimetry using the ventilated hood technique | Change from day 1 to day 2 to day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nighttime Eating, Protein, Obesity, Lipolysis, Metabolism