- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868631
Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements
February 25, 2020 updated by: Heidi Lynch, Point Loma Nazarene University
Muscle Growth and Development Following a 12-week Resistance Training Program in Men and Women Consuming Soy and Whey Protein Supplements
Soy and whey protein have different concentrations of leucine, an amino acid known to be a particularly potent simulator of muscle protein synthesis.
The purpose of this study is to determine whether matching soy and whey protein supplements for leucine content instead of by total protein content would contribute to differences in strength increases and muscle growth in response to 12 wk of resistance training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
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
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State 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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non-smoking
- body mass index (BMI) 18.5-24.9
- recreationally active
Exclusion Criteria:
- participated in structured weight training during the previous 12 month
- vegetarian or vegan
- presence of chronic disease
- pregnant, postpartum up to six months, lactating, or intention to become pregnant
- allergy to whey or soy
- changes in body weight more than 10 pounds in the past three months
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: Soy protein group
|
26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
|
Active Comparator: Whey protein group
|
19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lean Body Mass Change
Time Frame: Post-12 week intervention
|
assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
|
Post-12 week intervention
|
|
Muscle Tissue Thickness Change
Time Frame: Post-12 week intervention
|
assessed using changes in muscle thickness assessed by ultrasound (cm)
|
Post-12 week intervention
|
|
Leg Girth Changes
Time Frame: Post-12 week intervention
|
assessed using circumference measurements (cm)
|
Post-12 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peak Torque When Doing Leg Extensions
Time Frame: Post-12 week intervention
|
Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)
|
Post-12 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heidi Lynch, PhD, Point Loma Nazarene University
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)
August 15, 2016
Primary Completion (Actual)
April 30, 2017
Study Completion (Actual)
April 30, 2017
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 01435225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.