NCT04411173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

May 22, 2020

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Eight weeks

Secondary Outcomes (2)

  • Changes in muscular endurance by counting repetitions for each exercise test

    Eight weeks

  • Changes in resistance training volume by tracking how many pounds were lifted during each exercise

    Eight weeks

Study Arms (2)

Rice Protein

ACTIVE COMPARATOR

Rice Protein - 24 grams, chocolate, powder

Dietary Supplement: Whey Protein

Whey Protein

ACTIVE COMPARATOR

Whey Protein - 24 grams, chocolate, powder

Dietary Supplement: Whey Protein

Interventions

Whey ProteinDIETARY_SUPPLEMENT

Each condition (both rice and whey protein) match in color, flavor, and serving size.

Also known as: Rice Protein
Rice ProteinWhey Protein

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertrophy

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chad Kerksice, PhD

    Laboratory Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The supplements were delivered in identical containers with rather an "A" or "B" marked on the outside of the bag. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 2, 2020

Study Start

September 12, 2018

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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.

Locations