- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411173
Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations
May 27, 2020 updated by: Lindenwood University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Lindenwood University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rice Protein
Rice Protein - 24 grams, chocolate, powder
|
Each condition (both rice and whey protein) match in color, flavor, and serving size.
Other Names:
|
Active Comparator: Whey Protein
Whey Protein - 24 grams, chocolate, powder
|
Each condition (both rice and whey protein) match in color, flavor, and serving size.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Eight weeks
|
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
|
Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in muscular endurance by counting repetitions for each exercise test
Time Frame: Eight weeks
|
Examining the differences in muscular endurance from Day 1 to Final day
|
Eight weeks
|
Changes in resistance training volume by tracking how many pounds were lifted during each exercise
Time Frame: Eight weeks
|
Examining the differences in resistance training volume from Day 1 to Final day
|
Eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chad Kerksice, PhD, Laboratory Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2018
Primary Completion (Actual)
February 12, 2020
Study Completion (Actual)
February 12, 2020
Study Registration Dates
First Submitted
May 22, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 2, 2020
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-19-L0043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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