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OpenTrials
Completed

NCT Number: NCT02211391

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Science and Medicine, Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Casein protein

Other

The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined

Non-caloric placebo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Appetite

    Time frame: Change from Baseline to day 1, 2, and 3

    Appetite will be measured by visual analog scales

  2. Blood hormones

    Time frame: Change from Baseline to day 1, 2, and 3

    Hormones related to appetite and metabolism will be examined.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2014
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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