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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03868631
Enrollment
61
Registered
2019-03-11
Start date
2016-08-15
Completion date
2017-04-30
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal Muscle Growth

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.

Interventions

DIETARY_SUPPLEMENTWhey protein supplement

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

DIETARY_SUPPLEMENTSoy protein supplement

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

Sponsors

Point Loma Nazarene University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lean Body Mass ChangePost-12 week interventionassessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
Muscle Tissue Thickness ChangePost-12 week interventionassessed using changes in muscle thickness assessed by ultrasound (cm)
Leg Girth ChangesPost-12 week interventionassessed using circumference measurements (cm)

Secondary

MeasureTime frameDescription
Change in Peak Torque When Doing Leg ExtensionsPost-12 week interventionAssessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)

Countries

United States

Participant flow

Recruitment details

282 people responded to the screening survey online from August 2016 through January 2017. Data collection was completed by May 2017. 61 participants were randomized for study participation. Recruitment emails were sent to students at Arizona State University and others were contacted via word of mouth.

Participants by arm

ArmCount
Soy Protein Group
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
30
Whey Protein Group
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
31
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
Baseline to Week 6Adverse Event03
Baseline to Week 6Protocol Violation11
Baseline to Week 6Withdrawal by Subject30
Week 6 to Week 12 (Study Completion)Adverse Event20
Week 6 to Week 12 (Study Completion)Protocol Violation10
Week 6 to Week 12 (Study Completion)Withdrawal by Subject11

Baseline characteristics

CharacteristicWhey Protein GroupTotalSoy Protein Group
Age, Continuous22.22 years
STANDARD_DEVIATION 3.38
22.03 years
STANDARD_DEVIATION 3.81
21.83 years
STANDARD_DEVIATION 4.27
Appendicular lean body mass20.32806 kilograms
STANDARD_DEVIATION 5.096195
20.09263 kilograms
STANDARD_DEVIATION 5.171179
19.81796 kilograms
STANDARD_DEVIATION 5.353628
Body fat percent31.38214 percent body fat
STANDARD_DEVIATION 8.163188
31.16923 percent body fat
STANDARD_DEVIATION 8.115504
30.92083 percent body fat
STANDARD_DEVIATION 8.227645
Fat mass20.21259 kilograms
STANDARD_DEVIATION 6.261987
19.97825 kilograms
STANDARD_DEVIATION 6.468543
19.71463 kilograms
STANDARD_DEVIATION 6.818858
Height168.20 centimeters
STANDARD_DEVIATION 7.04
167.57 centimeters
STANDARD_DEVIATION 8.59
166.93 centimeters
STANDARD_DEVIATION 10.03
Lean body mass44.486 kilograms
STANDARD_DEVIATION 8.7167
44.301 kilograms
STANDARD_DEVIATION 9.3816
44.084 kilograms
STANDARD_DEVIATION 10.2896
Peak torque doing leg extensions (60 d/s)124.3479 Newton-meters
STANDARD_DEVIATION 39.91502
127.8901 Newton-meters
STANDARD_DEVIATION 42.03202
132.0228 Newton-meters
STANDARD_DEVIATION 44.87827
Peak torque doing leg flexions (60 d/s)60.4792 Newton-meters
STANDARD_DEVIATION 15.85495
62.2373 Newton-meters
STANDARD_DEVIATION 15.4526
64.2884 Newton-meters
STANDARD_DEVIATION 15.04077
Race/Ethnicity, Customized
Ethnicity
Non-white
13 Participants22 Participants9 Participants
Race/Ethnicity, Customized
Ethnicity
White
18 Participants39 Participants21 Participants
Region of Enrollment
United States
31 Participants61 Participants30 Participants
Sex: Female, Male
Female
21 Participants42 Participants21 Participants
Sex: Female, Male
Male
10 Participants19 Participants9 Participants
Vastus intermedius thickness1.572045 centimeters
STANDARD_DEVIATION 0.4095149
1.568222 centimeters
STANDARD_DEVIATION 0.3761121
1.563921 centimeters
STANDARD_DEVIATION 0.3433793
Vastus lateralis thickness2.330765 centimeters
STANDARD_DEVIATION 0.5032904
2.253989 centimeters
STANDARD_DEVIATION 0.4286374
2.167615 centimeters
STANDARD_DEVIATION 0.3136369
Weight66.9 kilograms
STANDARD_DEVIATION 10.1
66.26 kilograms
STANDARD_DEVIATION 11.61
65.5 kilograms
STANDARD_DEVIATION 13.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 31
other
Total, other adverse events
2 / 303 / 31
serious
Total, serious adverse events
0 / 300 / 31

Outcome results

Primary

Lean Body Mass Change

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

Time frame: Post-12 week intervention

ArmMeasureValue (MEAN)Dispersion
Soy Protein GroupLean Body Mass Change1.5 kilogramStandard Deviation 0.4
Whey Protein GroupLean Body Mass Change1.3 kilogramStandard Deviation 0.3
Comparison: Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.p-value: <0.05multilevel models for change
Primary

Leg Girth Changes

assessed using circumference measurements (cm)

Time frame: Post-12 week intervention

ArmMeasureValue (MEAN)Dispersion
Soy Protein GroupLeg Girth Changes-0.1865 centimeterStandard Deviation 0.05254
Whey Protein GroupLeg Girth Changes-0.0084 centimeterStandard Deviation 0.06227
Primary

Muscle Tissue Thickness Change

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

Time frame: Post-12 week intervention

ArmMeasureValue (MEAN)Dispersion
Soy Protein GroupMuscle Tissue Thickness Change0.12 centimeterStandard Deviation 0.16
Whey Protein GroupMuscle Tissue Thickness Change0.05 centimeterStandard Deviation 0.41
Secondary

Change in Peak Torque When Doing Leg Extensions

Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)

Time frame: Post-12 week intervention

ArmMeasureValue (MEAN)Dispersion
Soy Protein GroupChange in Peak Torque When Doing Leg Extensions12.1 Newton-metersStandard Deviation 13.5
Whey Protein GroupChange in Peak Torque When Doing Leg Extensions18.0 Newton-metersStandard Deviation 16.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026