Muscular HypertrophyNCT04509297
Resistance Training and Milk Supplementation
A study testing high protein milk in people with Muscular Hypertrophy, run by Marymount University at 1 site in United States.
Trial summary
Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains. The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Hypertrophy
- What is being tested?
- high protein milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to 5 May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years of age
- Healthy Males
- Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week).
Who cannot join
- smoking
- chronic alcohol consumption
- having any medical issues and diseases
- lactose intolerance
- the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-protein Milk Supplementation on Muscular Strength and Power, Body Composition, and Skeletal Muscle Regulatory Markers Following Heavy Resistance Training in Resistance-trained Men
Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains.
The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.
Read the detailed description
The aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to:
To investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.
- Conditions
- Muscular Hypertrophy
- Being tested
- high protein milk, Placebo
- Keywords
- Hypertrophy, body composition, milk, resistance training
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein milkDietary supplement
This intervention consisted of high protein milk consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.
PlaceboDietary supplement
This intervention consisted of the consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| High protein milk | Experimental | Experimental: High protein milk consumption This arm involved High protein milk whole consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. Receives: Dietary Supplement: high protein milk; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | This arm involved consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. drink r Receives: Dietary Supplement: high protein milk; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulatory Myokines levels
Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentration of myostatin and follistatin.
Measured: 6 weeks
Circulatory hormone levels
Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentrations of testosterone, IGF-1, growth hormone, insulin and cortisol
Measured: 6 weeks
Body composition
Lean body mass and body fatness will be evaluated using bioelectrical impedance
Measured: 6 weeks
Secondary outcomes (2)
Muscular Strength
Using a 1 repetition maximum test (defined as the maximal weight an individual can lift for only one repetition) for the bench press and back squat exercises
Measured: 6 weeks
Muscular Power
Using the Wingate test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start4 Jan 2018
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular HypertrophyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marymount University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tehran
- Responsible party
- Principal investigator, Alexei Wong, Marymount University
- Investigators
- Alexei Wong, Principal investigator, Marymount University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509297
- Sponsor's protocol ID
- Sports sciences institute.1396
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-protein Milk Supplementation on Muscular Strength and Power, Body Composition, and Skeletal Muscle Regulatory Markers Following Heavy Resistance Training in Resistance-trained Men
- ClinicalTrials.gov ID
- NCT04509297
- Acronym / sponsor ID
- Sports sciences institute.1396
- Conditions
- Muscular Hypertrophy
- Keywords
- Hypertrophy, body composition, milk, resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marymount UniversityUniversity, hospital or other
- Collaborators
- University of Tehran
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 12 Aug 2020 (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.
Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains.
The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.
Detailed description
The aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to:
To investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein milk | Experimental | Dietary Supplement: high protein milk, Dietary Supplement: PlaceboExperimental: High protein milk consumption This arm involved High protein milk whole consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. |
| Placebo | Placebo comparator | Dietary Supplement: high protein milk, Dietary Supplement: PlaceboThis arm involved consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. drink r |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-35 years of age
- Healthy Males
- Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week).
Key exclusion criteria (5 listed)
- smoking
- chronic alcohol consumption
- having any medical issues and diseases
- lactose intolerance
- the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation
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 |
|---|---|---|
| high protein milkThis intervention consisted of high protein milk consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. | Dietary supplement | High protein milk, Placebo |
| PlaceboThis intervention consisted of the consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime. | Dietary supplement | High protein milk, Placebo |
Primary outcome
Circulatory Myokines levels
Time frame: 6 weeks
Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentration of myostatin and follistatin.
Circulatory hormone levels
Time frame: 6 weeks
Fasting blood samples were collected from the antecubital vein using standard procedures and then analyzed to establish concentrations of testosterone, IGF-1, growth hormone, insulin and cortisol
Body composition
Time frame: 6 weeks
Lean body mass and body fatness will be evaluated using bioelectrical impedance
2 secondary outcomes
Muscular Strength
Time frame: 6 weeks
Muscular Power
Time frame: 6 weeks
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 12 Aug 2020.
- 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.
Alexei Wong principal investigator
Marymount 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 high protein milk in people with Muscular Hypertrophy, run by Marymount 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 3 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 12 Aug 2020. 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?
Circulatory Myokines levels (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 12 Aug 2020.