NCT03868631

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

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

August 15, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 27, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

February 25, 2019

Results QC Date

February 3, 2020

Last Update Submit

February 25, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Lean Body Mass Change

    assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)

    Post-12 week intervention

  • Muscle Tissue Thickness Change

    assessed using changes in muscle thickness assessed by ultrasound (cm)

    Post-12 week intervention

  • Leg Girth Changes

    assessed using circumference measurements (cm)

    Post-12 week intervention

Secondary Outcomes (1)

  • Change in Peak Torque When Doing Leg Extensions

    Post-12 week intervention

Study Arms (2)

Soy protein group

ACTIVE COMPARATOR
Dietary Supplement: Soy protein supplement

Whey protein group

ACTIVE COMPARATOR
Dietary Supplement: Whey protein supplement

Interventions

Whey protein supplementDIETARY_SUPPLEMENT

19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.

Whey protein group
Soy protein supplementDIETARY_SUPPLEMENT

26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.

Soy protein group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoking
  • body mass index (BMI) 18.5-24.9
  • recreationally active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Limitations and Caveats

1. No non-protein control (ex: placebo, maltodextrin) 2. No objective measurement of physical activity outside of the exercise intervention 3. No objective verification if the participants consumed protein powder on non-training days

Results Point of Contact

Title
Dr. Heidi Lynch
Organization
Point Loma Nazarene University

Study Officials

  • Heidi Lynch, PhD

    Point Loma Nazarene University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 11, 2019

Study Start

August 15, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

February 27, 2020

Results First Posted

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations