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

August 10, 2015 updated by: Michael J. Ormsbee, Florida State University

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tallahassee, Florida, United States, 32306
        • Institute of Sports Science and Medicine, Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael J Ormsbee, PhD, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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