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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Rice Protein
Rice Protein - 24 grams, chocolate, powder
Dietary supplement: Whey Protein
Each condition (both rice and whey protein) match in color, flavor, and serving size.
Other Names:
  • Rice Protein
Active Comparator: Whey Protein
Whey Protein - 24 grams, chocolate, powder
Dietary supplement: Whey Protein
Each condition (both rice and whey protein) match in color, flavor, and serving size.
Other Names:
  • Rice Protein

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lindenwood University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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