HypertrophyNCT04411173
Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations
A study testing Whey Protein in people with Hypertrophy, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x 15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations in young, healthy, resistance-trained men. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Whey Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2018to 12 Feb 2020
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-50 years, although it is anticipated that the majority of participants will be between 18 and 35 years of age.
- Participants will be healthy and free of disease as determined by evaluation of a medical history
- All participants will be required to abstain from taking any additional forms of nutritional supplementation (preworkouts, creatine, beta-alanine, etc.) for four weeks prior to beginning this study and for the entire duration of the study.
Who cannot join
- Those individuals with less than 12 months of structured resistance training experience will be excluded from the study.
- Individuals whose maximal relative upper body strength is below 1.0 will be excluded.
- Individuals whose maximal relative lower body strength is below 1.50 will be excluded.
- As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease will be excluded.
- Those individuals who present with any previous injury or illness that would prevent them from appropriately completing all exercise lifts will be excluded from the study.
- Participants who are not able to fit onto the DEXA table will not be able to participate in the research due to size restrictions of the equipment. This typically includes individuals exceeding 300 pounds or those greater than 6 feet 6 inches.
- Those individuals less than 18 and greater than 50 years of age will be excluded. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 50 years old lie outside of the target demographic for the current study.
- Participants who are determined to not be weight stable defined as week 0 and week 2 body mass levels deviating by 2% or more.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University
Saint Charles, Missouri, 63301
About this study
The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x 15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations in young, healthy, resistance-trained men.
Read the detailed description
The study will be conducted using a randomized, double-blind approach with individuals being provided two doses of either 15 grams of rice or 15 grams of whey protein over an 8-week supplementation period while completing a heavy resistance training. One dose will be ingested within one hour of completing each workout and the other dose will be ingested within an hour of going to bed. On non-workout days, one dose of 30 grams will be ingested within 60 minutes of going to bed. The resistance training protocol will follow a linear periodization, split-body resistance training design consisting of two upper body and two lower body workouts each week resulting in each muscle group being trained twice each week. To minimize the influence of training experience and any learning effect, individuals with at least 12 months of resistance training history will be recruited. Participants will also be required to complete a two-week lead-in period (8 total workouts) before beginning the supplementation regimen to become accustomed to the training program and to account for any early neurological adaptations. Participants will then continue to follow the resistance training program for an additional 8 weeks. To assess the efficacy of the two different forms of protein supplementation on resistance training adaptations, changes in fat-free, lean, and fat mass will be determined using DEXA. Maximal strength and endurance of both upper and lower-body muscle groups will be determined while anaerobic capacity markers will be measured with the completion of a Wingate anaerobic capacity test. Participants will also be provided nutritional recommendations in order to ensure adequate energy and macronutrient consumption to facilitate positive training adaptations and eliminate any potential influence of differing dietary intakes.
- Conditions
- Hypertrophy
- Being tested
- Whey Protein
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary supplement
Also called Rice Protein
Each condition (both rice and whey protein) match in color, flavor, and serving size.
| Study group | Role | What they receive |
|---|---|---|
| Rice Protein | Active comparator | Rice Protein - 24 grams, chocolate, powder Receives: Dietary Supplement: Whey Protein |
| Whey Protein | Active comparator | Whey Protein - 24 grams, chocolate, powder Receives: Dietary Supplement: Whey Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in upper- and lower-body strength via Dual-Energy X-ray Absorptiometry
Examining how much strength each participant gains (or loses) from Day 1 to Final day
Measured: Eight weeks
Changes in fat-free mass via Dual-Energy X-ray Absorptiometry
Examining the differences in fat-free mass from Day 1 to Final day
Measured: Eight weeks
Secondary outcomes (2)
Changes in muscular endurance by counting repetitions for each exercise test
Examining the differences in muscular endurance from Day 1 to Final day
Measured: Eight weeks
Changes in resistance training volume by tracking how many pounds were lifted during each exercise
Examining the differences in resistance training volume from Day 1 to Final day
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start12 Sep 2018
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Kerksice, PhD, Study director, Laboratory Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411173
- Sponsor's protocol ID
- IRB-19-L0043
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.
Publications
Moon JM, Ratliff KM, Blumkaitis JC, Harty PS, Zabriskie HA, Stecker RA, Currier BS, Jagim AR, Jager R, Purpura M, Kerksick CM. Effects of daily 24-gram doses of rice or whey protein on resistance training adaptations in trained males. J Int Soc Sports Nutr. 2020 Dec 1;17(1):60. doi: 10.1186/s12970-020-00394-1.
PubMed 33261645
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations
- ClinicalTrials.gov ID
- NCT04411173
- Acronym / sponsor ID
- IRB-19-L0043
- Conditions
- Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x 15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations in young, healthy, resistance-trained men.
Detailed description
The study will be conducted using a randomized, double-blind approach with individuals being provided two doses of either 15 grams of rice or 15 grams of whey protein over an 8-week supplementation period while completing a heavy resistance training. One dose will be ingested within one hour of completing each workout and the other dose will be ingested within an hour of going to bed. On non-workout days, one dose of 30 grams will be ingested within 60 minutes of going to bed. The resistance training protocol will follow a linear periodization, split-body resistance training design consisting of two upper body and two lower body workouts each week resulting in each muscle group being trained twice each week. To minimize the influence of training experience and any learning effect, individuals with at least 12 months of resistance training history will be recruited. Participants will also be required to complete a two-week lead-in period (8 total workouts) before beginning the supplementation regimen to become accustomed to the training program and to account for any early neurological adaptations. Participants will then continue to follow the resistance training program for an additional 8 weeks. To assess the efficacy of the two different forms of protein supplementation on resistance training adaptations, changes in fat-free, lean, and fat mass will be determined using DEXA. Maximal strength and endurance of both upper and lower-body muscle groups will be determined while anaerobic capacity markers will be measured with the completion of a Wingate anaerobic capacity test. Participants will also be provided nutritional recommendations in order to ensure adequate energy and macronutrient consumption to facilitate positive training adaptations and eliminate any potential influence of differing dietary intakes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice Protein | Active comparator | Dietary Supplement: Whey ProteinRice Protein - 24 grams, chocolate, powder |
| Whey Protein | Active comparator | Dietary Supplement: Whey ProteinWhey Protein - 24 grams, chocolate, powder |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-50 years, although it is anticipated that the majority of participants will be between 18 and 35 years of age.
- Participants will be healthy and free of disease as determined by evaluation of a medical history
- All participants will be required to abstain from taking any additional forms of nutritional supplementation (preworkouts, creatine, beta-alanine, etc.) for four weeks prior to beginning this study and for the entire duration of the study.
Key exclusion criteria (8 listed)
- Those individuals with less than 12 months of structured resistance training experience will be excluded from the study.
- Individuals whose maximal relative upper body strength is below 1.0 will be excluded.
- Individuals whose maximal relative lower body strength is below 1.50 will be excluded.
- As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease will be excluded.
- Those individuals who present with any previous injury or illness that would prevent them from appropriately completing all exercise lifts will be excluded from the study.
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 |
|---|---|---|
| Whey ProteinAlso: Rice ProteinEach condition (both rice and whey protein) match in color, flavor, and serving size. | Dietary supplement | Rice Protein, Whey Protein |
Primary outcome
Changes in upper- and lower-body strength via Dual-Energy X-ray Absorptiometry
Time frame: Eight weeks
Examining how much strength each participant gains (or loses) from Day 1 to Final day
Changes in fat-free mass via Dual-Energy X-ray Absorptiometry
Time frame: Eight weeks
Examining the differences in fat-free mass from Day 1 to Final day
2 secondary outcomes
Changes in muscular endurance by counting repetitions for each exercise test
Time frame: Eight weeks
Changes in resistance training volume by tracking how many pounds were lifted during each exercise
Time frame: Eight 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 2 Jun 2020.
- Derived from this study: PubMed 33261645Moon JM, Ratliff KM, Blumkaitis JC, Harty PS, Zabriskie HA, Stecker RA, Currier BS, Jagim AR, Jager R, Purpura M, Kerksick CM. Effects of daily 24-gram doses of rice or whey protein on resistance training adaptations in trained males. J Int Soc Sports Nutr. 2020 Dec 1;17(1):60. doi: 10.1186/s12970-020-00394-1.
- Individual participant dataSharing planned: No. All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.
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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.
Chad Kerksice, PhD study director
Laboratory Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein in people with Hypertrophy, run by Lindenwood 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 8 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 2 Jun 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. 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?
Changes in upper- and lower-body strength via Dual-Energy X-ray Absorptiometry (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 NCT04411173, 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 2 Jun 2020.