ObesityNCT02211391
Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men
A study testing Casein Protein in people with Obesity, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Casein Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, sedentary overweight or obese (BMI ≥25 kg/m^2; body fat ≥ 25% ) men
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Sports Science and Medicine, Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Casein Protein, Non-caloric placebo
- Keywords
- Nighttime Eating, Protein, Obesity, Lipolysis, Metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein ProteinOther
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 placeboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Casein Protein | Experimental | Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep Receives: Other: Casein Protein |
| Non-caloric Placebo | Placebo comparator | The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep Receives: Other: Non-caloric placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from day 1 to day 2 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Michael J Ormsbee, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211391
- Sponsor's protocol ID
- HSC# 2014.13509
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men.
- ClinicalTrials.gov ID
- NCT02211391
- Acronym / sponsor ID
- HSC# 2014.13509
- Conditions
- Obesity
- Keywords
- Nighttime Eating, Protein, Obesity, Lipolysis, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Casein Protein | Experimental | Other: Casein ProteinCasein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep |
| Non-caloric Placebo | Placebo comparator | Other: Non-caloric placeboThe non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, sedentary overweight or obese (BMI ≥25 kg/m^2; body fat ≥ 25% ) men
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casein ProteinThe effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined | Other | Casein Protein |
| Non-caloric placeboThe effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined | Other | Non-caloric Placebo |
Primary outcome
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
1 secondary outcome
Resting Metabolic Rate (RMR)
Time frame: Change from day 1 to day 2 to day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Ormsbee, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein Protein in people with Obesity, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipolysis (time frame: Change from day 1 to day 2 to day 3 of testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.