- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211391
Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men
The Effect of Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Institute of Sports Science and Medicine, Florida State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Casein Protein
Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep
|
The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
|
|
Placebo Comparator: Non-caloric Placebo
The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipolysis
Time Frame: Change from day 1 to day 2 to day 3 of testing
|
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)
Time Frame: Change from day 1 to day 2 to day 3
|
RMR will be measured with indirect calorimetry using the ventilated hood technique
|
Change from day 1 to day 2 to day 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite
Time Frame: Change from Baseline to day 1, 2, and 3
|
Appetite will be measured by visual analog scales
|
Change from Baseline to day 1, 2, and 3
|
|
Blood hormones
Time Frame: Change from Baseline to day 1, 2, and 3
|
Hormones related to appetite and metabolism will be examined.
|
Change from Baseline to day 1, 2, and 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael J Ormsbee, PhD, Florida State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC# 2014.13509
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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