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CompletedNCT02211391Updated Aug 13, 2015

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

An interventional study of Casein Protein and Non-caloric placebo in Obesity, sponsored by Florida State University. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • Nighttime Eating
  • Protein
  • Obesity
  • Lipolysis
  • Metabolism
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 12 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy, sedentary overweight or obese (BMI ≥25 kg/m\^2; body fat ≥ 25% ) men

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Casein Protein

    Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep

    Other: Casein Protein

  • 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

    Other: Non-caloric placebo

Interventions

  • OtherCasein Protein

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

  • OtherNon-caloric placebo

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from day 1 to day 2 to day 3 of testing

Secondary outcomes

  1. Resting Metabolic Rate (RMR)

    RMR will be measured with indirect calorimetry using the ventilated hood technique

    Time frame: Change from day 1 to day 2 to day 3

Other outcomes

  1. Appetite

    Appetite will be measured by visual analog scales

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

  2. Blood hormones

    Hormones related to appetite and metabolism will be examined.

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

07

Study locations

1 site
  • Institute of Sports Science and Medicine, Florida State University
    Tallahassee, Florida 32306, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02211391
Lead sponsor
Florida State University
Responsible party
Michael J. Ormsbee (Assistant Professor, Florida State University) — Principal investigator
First posted
Aug 7, 2014
Start date
Jul 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Aug 13, 2015

Study contacts

Michael J Ormsbee, PhD
principal investigator · Florida State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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