Skeletal Muscle GrowthNCT03868631

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

A study testing Whey protein supplement and Soy protein supplement in people with Skeletal Muscle Growth, run by Point Loma Nazarene University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Skeletal Muscle Growth
What is being tested?: Whey protein supplement and Soy protein supplement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2016to 30 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona State University
Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: Muscle Growth and Development Following a 12-week Resistance Training Program in Men and Women Consuming Soy and Whey Protein Supplements

Conditions: Skeletal Muscle Growth
Being tested: Whey protein supplement, Soy protein supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whey protein supplementDietary supplement
19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Soy protein supplementDietary supplement
26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.

Study groups in NCT03868631
Study group	Role	What they receive
Soy protein group	Active comparator	Not described Receives: Dietary Supplement: Soy protein supplement
Whey protein group	Active comparator	Not described Receives: Dietary Supplement: Whey protein supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

Lean Body Mass Change
assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
Measured: Post-12 week intervention
Muscle Tissue Thickness Change
assessed using changes in muscle thickness assessed by ultrasound (cm)
Measured: Post-12 week intervention
Leg Girth Changes
assessed using circumference measurements (cm)
Measured: Post-12 week intervention

Secondary outcomes (1)

Change in Peak Torque When Doing Leg Extensions
Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)
Measured: Post-12 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201630 Apr 2017

First posted11 Mar 2019
Study start15 Aug 2016
Primary completion30 Apr 2017
Study completion30 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skeletal Muscle GrowthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03868631
Sponsor's protocol ID: 01435225
Status last verified: Feb 2020
First submitted: 25 Feb 2019
Last updated: 27 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Muscle Growth and Development Following a 12-week Resistance Training Program in Men and Women Consuming Soy and Whey Protein Supplements
ClinicalTrials.gov ID: NCT03868631
Acronym / sponsor ID: 01435225
Conditions: Skeletal Muscle Growth
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Point Loma Nazarene UniversityUniversity, hospital or other
Study start: 15 Aug 2016 (actual)
Primary completion: 30 Apr 2017 (actual)
Study completion: 30 Apr 2017 (actual)
First posted: 11 Mar 2019 (actual)
Results: Posted 27 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Soy protein group	Active comparator	Dietary Supplement: Soy protein supplement
Whey protein group	Active comparator	Dietary Supplement: Whey protein supplement

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whey protein supplement19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.	Dietary supplement	Whey protein group
Soy protein supplement26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Dietary supplement	Soy protein group

Primary outcome

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)
Muscle Tissue Thickness Change
Time frame: Post-12 week intervention
assessed using changes in muscle thickness assessed by ultrasound (cm)
Leg Girth Changes
Time frame: Post-12 week intervention
assessed using circumference measurements (cm)

1 secondary outcome

Change in Peak Torque When Doing Leg Extensions
Time frame: Post-12 week intervention

Results and safety

Results posted to the registry on 27 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Soy Protein Group	30	26
Whey Protein Group	31	27

Primary outcome: Lean Body Mass Change

Time frame: Post-12 week intervention. Mean (Standard Deviation). Unit: kilogram

Measure	Soy Protein Group n = 30	Whey Protein Group n = 31
Value	1.5 (0.4)	1.3 (0.3)

Soy Protein Group vs Whey Protein Group: p <0.05, multilevel models for change

Primary outcome: Muscle Tissue Thickness Change

Time frame: Post-12 week intervention. Mean (Standard Deviation). Unit: centimeter

Measure	Soy Protein Group n = 30	Whey Protein Group n = 31
Value	0.12 (0.16)	0.05 (0.41)

Primary outcome: Leg Girth Changes

Time frame: Post-12 week intervention. Mean (Standard Deviation). Unit: centimeter

Measure	Soy Protein Group n = 30	Whey Protein Group n = 31
Value	-0.1865 (0.05254)	-0.0084 (0.06227)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Soy Protein Group	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30
Whey Protein Group	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heidi Lynch, PhD principal investigator

Point Loma Nazarene University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein supplement and Soy protein supplement in people with Skeletal Muscle Growth, run by Point Loma Nazarene University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean Body Mass Change (time frame: Post-12 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.