HealthyNCT03573687
Effects of Protein Timing and Resistance Exercise on Fat Metabolism
A study testing Micellar Casein Protein and Resistance Exercise Training in people with Healthy, run by Florida State University at 1 site in United States.
Trial summary
The extent to which resistance exercise training and protein timing effects localized (belly fat) and systemic (whole body) fat metabolism in resistance-trained women is unknown. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Micellar Casein Protein and Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 28 Feb 2018
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Resistance-trained (able to squat 1.0 times their body weight, and bench press 0.75 times body weight, adapted from ACSM Guidelines and piloted in our laboratory)
- Normal weight (BMI = 18.5-25 kg/m2; body fat <33%)
- Normally menstruating (on or off oral contraceptives)
- Females.
Who cannot join
- Uncontrolled thyroid dysfunction (not on medication)
- Musculoskeletal disorders
- Currently smoke
- Have milk allergies
- Currently take medications or supplements known to affect substrate metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Sports Sciences and Medicine, Florida State University
Tallahassee, Florida, 32306
About this study
Official title: The Effect of Protein Timing and Resistance Exercise on Lipolysis and Fat Oxidation in Resistance-Trained Women
The extent to which resistance exercise training and protein timing effects localized (belly fat) and systemic (whole body) fat metabolism in resistance-trained women is unknown. Therefore, this study will assess subcutaneous abdominal adipose tissue lipolytic rate and whole body substrate utilization over the course of two trials: 1) consuming casein protein during the day, and 2) consuming casein protein at night, before bed.
Read the detailed description
Nighttime eating, and specifically eating after dinner, has attracted significant attention in recent years, particularly for the onslaught of media claiming the negative implications on body weight and overall health. Some studies have indeed indicated that chronically eating high-energy, mixed-meals rich in carbohydrates (CHO) and fats at night contributes to weight gain and abdominal obesity. However, research to support these negative claims is scant. Conversely, the practice of nighttime eating of small protein (PRO) snacks has been widely utilized anecdotally in populations such as bodybuilders in an attempt to avoid catabolism of muscle mass during the sleeping hours.
It has been shown that nighttime consumption of small portions (<200 kcals) of PRO elicits beneficial effects on metabolism such as increased next-morning resting metabolic rate (RMR). Likewise, the combination of nighttime PRO consumption and RT improves factors that contribute to fat loss such as elevated muscle mass due to an increase in muscle protein synthesis and energy expenditure. Further, there is emerging research suggesting the benefits of nighttime PRO consumption on fat metabolism (specifically the subcutaneous abdominal adipose tissue [SCAAT]). The SCAAT is of particular interest in metabolism research, as the upper body subcutaneous tissue (i.e. SCAAT) supplies most of the circulating free fatty acids (FFA) during the overnight hours in lean individuals. Therefore, if one can optimize the timing of dietary PRO during a window at which SCAAT is elevated (nighttime), theoretically, mobilization and oxidation of fats could be optimized.
Research regarding nighttime eating, specifically regarding fat metabolism, is in its infancy, and thus, many gaps in the literature require elucidation. First, and certainly most importantly, the limited research studies examining the effects of nighttime PRO consumption have not methodologically matched for timing of PRO intake. Therefore, it is unclear whether any reported benefits of the published nighttime PRO studies were a consequence of the addition of PRO calories or specifically due to the consumption of PRO at night. Thus, in order to make optimal comparisons and conclusions, it is imperative to study the metabolic effects of dietary PRO consumed at night versus other times of day.
Therefore, the purpose of this project is to: 1) determine the effects of RT on post-exercise lipolytic rate in resistance-trained women; and 2) determine the effects of timing of acute protein PRO ingestion (nighttime PRO consumption [NP] and daytime PRO consumption [DP] trials) after a RT bout on SCAAT lipolytic rate, metabolic rate, and serum hormones (glucose, insulin, growth hormone, adiponectin, glycerol) throughout the day, overnight and into the next morning.
- Conditions
- Healthy
- Being tested
- Micellar Casein Protein, Resistance Exercise Training
- Keywords
- protein, lipolysis, fat oxidation, resistance training, nutrient timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar Casein ProteinDietary supplement
The micellar casein protein supplement (PRO, total protein content: 30 g, 120 kcals; 30 g micellar protein) and non-caloric sensory-matched placebo (PLA, 0kcals) will be specifically formulated by Dymatize® Nutrition FrieslandCampina® and consumed in a randomized order. Participants will consume the daytime supplement 30 minutes after RT and the nighttime supplement about 30 minutes before bedtime. The supplements will be premixed, taste-matched (chocolate), and provided in opaque shaker bottles.
Resistance Exercise TrainingOther
Resistance exercise training (RT) will target the full body and exercises will be performed using a barbell. Exercises will be performed in the following order: back squat, bench press, Romanian deadlift, bent-over row, shoulder press, and reverse lunges)
| Study group | Role | What they receive |
|---|---|---|
| RT on Fat Metabolism | Experimental | Determine the extent to which a full-body acute RT protocol will affect intra-RT and post-RT SCAAT lipolytic rate, and post-RT whole-body substrate utilization in RT women compared to baseline measures (independent of Aims 2 and 3). Receives: Other: Resistance Exercise Training |
| PRO Timing on Fat Metabolism | Experimental | Assess the differences in overnight and next morning SCAAT lipolytic rate and next-morning whole-body substrate utilization compared to baseline between acute NP and DP consumption trials after a RT bout in RT women. Receives: Dietary Supplement: Micellar Casein Protein; Other: Resistance Exercise Training |
| PRO Timing on Markers of Fat Metabolism | Experimental | Assess the differences in overnight and next morning metabolic biomarkers of fat metabolism compared to baseline between acute nighttime PRO (NP) consumption versus daytime PRO (DP) consumption trials after a RT bout in RT women. Receives: Dietary Supplement: Micellar Casein Protein; Other: Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipolysis
Lipolysis is the way that fat cells mobilize the stored fat to enter into blood circulation. Lipolysis can be measured using a technique called microdialysis. In short, a semi-permeable probe is inserted into the subcutaneous abdominal adipose tissue (SCAAT, or belly fat). Saline combined with a minute amount of ethanol is perfused into the SCAAT, and interstitial fluid is collected out. The concentration of ethanol in the interstitial fluid sample is an indicator of blood flow within the tissue. Glycerol and free fatty acid concentration is measured to indicated rate of fat metabolism (specifically glycerol). The area under the curve for glycerol concentration over time (AUCgly) will be calculated for each of time point. Microdialysis dialysate samples will be measured during the NP and DP trials at fifteen separate time points throughout each visit.
Measured: 18 hours
Secondary outcomes (2)
Hormone Concentrations
Serum samples will be analyzed for the assessment of glucose, insulin, and growth hormone on collections 1, 3, 4, and 5. Serum glycerol will be assessed at 5 time points. Serum catecholamines will be assessed at time points 1, 2 and 3. The timeline for blood collections is as follows:
- During microdialysis probe equilibration (~1600 hours);
- Half way through the RT protocol (~1800 hours, after the third exercise: Romanian deadlift)
- Thirty minutes after daytime supplement (1900 hours);
- Thirty minutes after nighttime supplement (2300 hours), and;
- The following morning after RMR (0750 hours)
Measured: 18 hours
Fat oxidation
Fat oxidation is when those stored fats enter into the muscle cells and are able to be oxidized to form energy. Fat oxidation will be quantified by measuring resting metabolic rate (RMR, amount of calories burned at rest) and respiratory exchange ratio (RER, measure of whole-body substrate utilization) using a dilution technique and open-circuit indirect calorimetry (ParvoMedics TrueOne 2400 metabolic cart, Sandy, UT). This technique uses a ventilated hood covering the participants' head and torso. Participants will be asked to remain awake, quiet, and as motionless as possible in a semi-recumbent position in a quiet, dark, climate-controlled isolated room (20-23°C). Resting metabolism will be measured on four separate occasions.
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start20 Mar 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover, double-blind, acute study with two conditions: nighttime PRO consumption (NP) and daytime PRO consumption (DP).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573687
- Sponsor's protocol ID
- NPRO
- Status last verified
- Jul 2018
- First submitted
- 23 Jan 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allman BR, Morrissey MC, Kim JS, Panton LB, Contreras RJ, Hickner RC, Ormsbee MJ. Lipolysis and Fat Oxidation Are Not Altered with Presleep Compared with Daytime Casein Protein Intake in Resistance-Trained Women. J Nutr. 2020 Jan 1;150(1):47-54. doi: 10.1093/jn/nxz186.
PubMed 31504693
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Timing and Resistance Exercise on Lipolysis and Fat Oxidation in Resistance-Trained Women
- ClinicalTrials.gov ID
- NCT03573687
- Acronym / sponsor ID
- NPRO
- Conditions
- Healthy
- Keywords
- protein, lipolysis, fat oxidation, resistance training, nutrient timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 29 Jun 2018 (actual)
- 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.
The extent to which resistance exercise training and protein timing effects localized (belly fat) and systemic (whole body) fat metabolism in resistance-trained women is unknown. Therefore, this study will assess subcutaneous abdominal adipose tissue lipolytic rate and whole body substrate utilization over the course of two trials: 1) consuming casein protein during the day, and 2) consuming casein protein at night, before bed.
Detailed description
Nighttime eating, and specifically eating after dinner, has attracted significant attention in recent years, particularly for the onslaught of media claiming the negative implications on body weight and overall health. Some studies have indeed indicated that chronically eating high-energy, mixed-meals rich in carbohydrates (CHO) and fats at night contributes to weight gain and abdominal obesity. However, research to support these negative claims is scant. Conversely, the practice of nighttime eating of small protein (PRO) snacks has been widely utilized anecdotally in populations such as bodybuilders in an attempt to avoid catabolism of muscle mass during the sleeping hours.
It has been shown that nighttime consumption of small portions (<200 kcals) of PRO elicits beneficial effects on metabolism such as increased next-morning resting metabolic rate (RMR). Likewise, the combination of nighttime PRO consumption and RT improves factors that contribute to fat loss such as elevated muscle mass due to an increase in muscle protein synthesis and energy expenditure. Further, there is emerging research suggesting the benefits of nighttime PRO consumption on fat metabolism (specifically the subcutaneous abdominal adipose tissue [SCAAT]). The SCAAT is of particular interest in metabolism research, as the upper body subcutaneous tissue (i.e. SCAAT) supplies most of the circulating free fatty acids (FFA) during the overnight hours in lean individuals. Therefore, if one can optimize the timing of dietary PRO during a window at which SCAAT is elevated (nighttime), theoretically, mobilization and oxidation of fats could be optimized.
Research regarding nighttime eating, specifically regarding fat metabolism, is in its infancy, and thus, many gaps in the literature require elucidation. First, and certainly most importantly, the limited research studies examining the effects of nighttime PRO consumption have not methodologically matched for timing of PRO intake. Therefore, it is unclear whether any reported benefits of the published nighttime PRO studies were a consequence of the addition of PRO calories or specifically due to the consumption of PRO at night. Thus, in order to make optimal comparisons and conclusions, it is imperative to study the metabolic effects of dietary PRO consumed at night versus other times of day.
Therefore, the purpose of this project is to: 1) determine the effects of RT on post-exercise lipolytic rate in resistance-trained women; and 2) determine the effects of timing of acute protein PRO ingestion (nighttime PRO consumption [NP] and daytime PRO consumption [DP] trials) after a RT bout on SCAAT lipolytic rate, metabolic rate, and serum hormones (glucose, insulin, growth hormone, adiponectin, glycerol) throughout the day, overnight and into the next morning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, crossover, double-blind, acute study with two conditions: nighttime PRO consumption (NP) and daytime PRO consumption (DP).
| Arm | Type | Receives |
|---|---|---|
| RT on Fat Metabolism | Experimental | Other: Resistance Exercise TrainingDetermine the extent to which a full-body acute RT protocol will affect intra-RT and post-RT SCAAT lipolytic rate, and post-RT whole-body substrate utilization in RT women compared to baseline measures (independent of Aims 2 and 3). |
| PRO Timing on Fat Metabolism | Experimental | Dietary Supplement: Micellar Casein Protein, Other: Resistance Exercise TrainingAssess the differences in overnight and next morning SCAAT lipolytic rate and next-morning whole-body substrate utilization compared to baseline between acute NP and DP consumption trials after a RT bout in RT women. |
| PRO Timing on Markers of Fat Metabolism | Experimental | Dietary Supplement: Micellar Casein Protein, Other: Resistance Exercise TrainingAssess the differences in overnight and next morning metabolic biomarkers of fat metabolism compared to baseline between acute nighttime PRO (NP) consumption versus daytime PRO (DP) consumption trials after a RT bout in RT women. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Resistance-trained (able to squat 1.0 times their body weight, and bench press 0.75 times body weight, adapted from ACSM Guidelines and piloted in our laboratory)
- Normal weight (BMI = 18.5-25 kg/m2; body fat <33%)
- Normally menstruating (on or off oral contraceptives)
- Females.
Key exclusion criteria (5 listed)
- Uncontrolled thyroid dysfunction (not on medication)
- Musculoskeletal disorders
- Currently smoke
- Have milk allergies
- Currently take medications or supplements known to affect substrate metabolism.
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 |
|---|---|---|
| Micellar Casein ProteinThe micellar casein protein supplement (PRO, total protein content: 30 g, 120 kcals; 30 g micellar protein) and non-caloric sensory-matched placebo (PLA, 0kcals) will be specifically formulated by Dymatize® Nutrition FrieslandCampina® and consumed in a randomized order. Participants will consume the daytime supplement 30 minutes after RT and the nighttime supplement about 30 minutes before bedtime. The supplements will be premixed, taste-matched (chocolate), and provided in opaque shaker bottles. | Dietary supplement | PRO Timing on Fat Metabolism, PRO Timing on Markers of Fat Metabolism |
| Resistance Exercise TrainingResistance exercise training (RT) will target the full body and exercises will be performed using a barbell. Exercises will be performed in the following order: back squat, bench press, Romanian deadlift, bent-over row, shoulder press, and reverse lunges) | Other | PRO Timing on Fat Metabolism, PRO Timing on Markers of Fat Metabolism, RT on Fat Metabolism |
Primary outcome
Lipolysis
Time frame: 18 hours
Lipolysis is the way that fat cells mobilize the stored fat to enter into blood circulation. Lipolysis can be measured using a technique called microdialysis. In short, a semi-permeable probe is inserted into the subcutaneous abdominal adipose tissue (SCAAT, or belly fat). Saline combined with a minute amount of ethanol is perfused into the SCAAT, and interstitial fluid is collected out. The concentration of ethanol in the interstitial fluid sample is an indicator of blood flow within the tissue. Glycerol and free fatty acid concentration is measured to indicated rate of fat metabolism (specifically glycerol). The area under the curve for glycerol concentration over time (AUCgly) will be calculated for each of time point. Microdialysis dialysate samples will be measured during the NP and DP trials at fifteen separate time points throughout each visit.
2 secondary outcomes
Hormone Concentrations
Time frame: 18 hours
Fat oxidation
Time frame: 18 hours
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 6 Jul 2018.
- Derived from this study: PubMed 31504693Allman BR, Morrissey MC, Kim JS, Panton LB, Contreras RJ, Hickner RC, Ormsbee MJ. Lipolysis and Fat Oxidation Are Not Altered with Presleep Compared with Daytime Casein Protein Intake in Resistance-Trained Women. J Nutr. 2020 Jan 1;150(1):47-54. doi: 10.1093/jn/nxz186.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micellar Casein Protein and Resistance Exercise Training in people with Healthy, 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 5 inclusion and 5 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 6 Jul 2018. 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. 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: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573687, which also lists 1 linked publication.
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 6 Jul 2018.