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Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements

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ClinicalTrials.gov Identifier: NCT03868631
Recruitment Status : Completed
First Posted : March 11, 2019
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Heidi Lynch, Point Loma Nazarene University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skeletal Muscle Growth Dietary Supplement: Whey protein supplement Dietary Supplement: Soy protein supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Muscle Growth and Development Following a 12-week Resistance Training Program in Men and Women Consuming Soy and Whey Protein Supplements
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Soy protein group Dietary Supplement: Soy protein supplement
26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.

Active Comparator: Whey protein group Dietary Supplement: Whey protein supplement
19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.




Primary Outcome Measures :
  1. 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)

  2. Muscle Tissue Thickness Change [ Time Frame: Post-12 week intervention ]
    assessed using changes in muscle thickness assessed by ultrasound (cm)

  3. Leg Girth Changes [ Time Frame: Post-12 week intervention ]
    assessed using circumference measurements (cm)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868631


Locations
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United States, Arizona
Arizona State University
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Point Loma Nazarene University
Investigators
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Principal Investigator: Heidi Lynch, PhD Point Loma Nazarene University
  Study Documents (Full-Text)

Documents provided by Heidi Lynch, Point Loma Nazarene University:
Study Protocol  [PDF] August 1, 2016
Statistical Analysis Plan  [PDF] August 1, 2016
Informed Consent Form  [PDF] January 27, 2017

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Responsible Party: Heidi Lynch, Assistant Professor, Point Loma Nazarene University
ClinicalTrials.gov Identifier: NCT03868631    
Other Study ID Numbers: 01435225
First Posted: March 11, 2019    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No