Trial Outcomes & Findings for Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements (NCT NCT03868631)
NCT ID: NCT03868631
Last Updated: 2020-02-27
Results Overview
assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Post-12 week intervention
Results posted on
2020-02-27
Participant Flow
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.
Participant milestones
| Measure |
Soy Protein Group
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Baseline to Week 6
STARTED
|
30
|
31
|
|
Baseline to Week 6
COMPLETED
|
26
|
27
|
|
Baseline to Week 6
NOT COMPLETED
|
4
|
4
|
|
Week 6 to Week 12 (Study Completion)
STARTED
|
26
|
27
|
|
Week 6 to Week 12 (Study Completion)
COMPLETED
|
22
|
26
|
|
Week 6 to Week 12 (Study Completion)
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Soy Protein Group
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Baseline to Week 6
Adverse Event
|
0
|
3
|
|
Baseline to Week 6
Protocol Violation
|
1
|
1
|
|
Baseline to Week 6
Withdrawal by Subject
|
3
|
0
|
|
Week 6 to Week 12 (Study Completion)
Adverse Event
|
2
|
0
|
|
Week 6 to Week 12 (Study Completion)
Protocol Violation
|
1
|
0
|
|
Week 6 to Week 12 (Study Completion)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements
Baseline characteristics by cohort
| Measure |
Soy Protein Group
n=30 Participants
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 Participants
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.83 years
STANDARD_DEVIATION 4.27 • n=99 Participants
|
22.22 years
STANDARD_DEVIATION 3.38 • n=107 Participants
|
22.03 years
STANDARD_DEVIATION 3.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-white
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Height
|
166.93 centimeters
STANDARD_DEVIATION 10.03 • n=99 Participants
|
168.20 centimeters
STANDARD_DEVIATION 7.04 • n=107 Participants
|
167.57 centimeters
STANDARD_DEVIATION 8.59 • n=206 Participants
|
|
Weight
|
65.5 kilograms
STANDARD_DEVIATION 13.3 • n=99 Participants
|
66.9 kilograms
STANDARD_DEVIATION 10.1 • n=107 Participants
|
66.26 kilograms
STANDARD_DEVIATION 11.61 • n=206 Participants
|
|
Lean body mass
|
44.084 kilograms
STANDARD_DEVIATION 10.2896 • n=99 Participants
|
44.486 kilograms
STANDARD_DEVIATION 8.7167 • n=107 Participants
|
44.301 kilograms
STANDARD_DEVIATION 9.3816 • n=206 Participants
|
|
Appendicular lean body mass
|
19.81796 kilograms
STANDARD_DEVIATION 5.353628 • n=99 Participants
|
20.32806 kilograms
STANDARD_DEVIATION 5.096195 • n=107 Participants
|
20.09263 kilograms
STANDARD_DEVIATION 5.171179 • n=206 Participants
|
|
Fat mass
|
19.71463 kilograms
STANDARD_DEVIATION 6.818858 • n=99 Participants
|
20.21259 kilograms
STANDARD_DEVIATION 6.261987 • n=107 Participants
|
19.97825 kilograms
STANDARD_DEVIATION 6.468543 • n=206 Participants
|
|
Body fat percent
|
30.92083 percent body fat
STANDARD_DEVIATION 8.227645 • n=99 Participants
|
31.38214 percent body fat
STANDARD_DEVIATION 8.163188 • n=107 Participants
|
31.16923 percent body fat
STANDARD_DEVIATION 8.115504 • n=206 Participants
|
|
Vastus lateralis thickness
|
2.167615 centimeters
STANDARD_DEVIATION 0.3136369 • n=99 Participants
|
2.330765 centimeters
STANDARD_DEVIATION 0.5032904 • n=107 Participants
|
2.253989 centimeters
STANDARD_DEVIATION 0.4286374 • n=206 Participants
|
|
Vastus intermedius thickness
|
1.563921 centimeters
STANDARD_DEVIATION 0.3433793 • n=99 Participants
|
1.572045 centimeters
STANDARD_DEVIATION 0.4095149 • n=107 Participants
|
1.568222 centimeters
STANDARD_DEVIATION 0.3761121 • n=206 Participants
|
|
Peak torque doing leg extensions (60 d/s)
|
132.0228 Newton-meters
STANDARD_DEVIATION 44.87827 • n=99 Participants
|
124.3479 Newton-meters
STANDARD_DEVIATION 39.91502 • n=107 Participants
|
127.8901 Newton-meters
STANDARD_DEVIATION 42.03202 • n=206 Participants
|
|
Peak torque doing leg flexions (60 d/s)
|
64.2884 Newton-meters
STANDARD_DEVIATION 15.04077 • n=99 Participants
|
60.4792 Newton-meters
STANDARD_DEVIATION 15.85495 • n=107 Participants
|
62.2373 Newton-meters
STANDARD_DEVIATION 15.45260 • n=206 Participants
|
PRIMARY outcome
Timeframe: Post-12 week interventionassessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
Outcome measures
| Measure |
Soy Protein Group
n=30 Participants
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 Participants
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Lean Body Mass Change
|
1.5 kilogram
Standard Deviation 0.4
|
1.3 kilogram
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Post-12 week interventionassessed using changes in muscle thickness assessed by ultrasound (cm)
Outcome measures
| Measure |
Soy Protein Group
n=30 Participants
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 Participants
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Muscle Tissue Thickness Change
|
0.12 centimeter
Standard Deviation 0.16
|
0.05 centimeter
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: Post-12 week interventionassessed using circumference measurements (cm)
Outcome measures
| Measure |
Soy Protein Group
n=30 Participants
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 Participants
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Leg Girth Changes
|
-0.1865 centimeter
Standard Deviation 0.05254
|
-0.0084 centimeter
Standard Deviation 0.06227
|
SECONDARY outcome
Timeframe: Post-12 week interventionAssessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)
Outcome measures
| Measure |
Soy Protein Group
n=30 Participants
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 Participants
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Change in Peak Torque When Doing Leg Extensions
|
12.1 Newton-meters
Standard Deviation 13.5
|
18.0 Newton-meters
Standard Deviation 16.1
|
Adverse Events
Soy Protein Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Whey Protein Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soy Protein Group
n=30 participants at risk
Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
|
Whey Protein Group
n=31 participants at risk
Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • 12 weeks
|
3.2%
1/31 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Vomited
|
0.00%
0/30 • 12 weeks
|
3.2%
1/31 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place