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

• Sponsor: Point Loma Nazarene University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03868631
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 15, 2016
• Actual Primary Completion Date: Apr 30, 2017
• Actual Study Completion Date: Apr 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Lean Body Mass Change [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 [Post-12 week intervention]

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

3. Leg Girth Changes [Post-12 week intervention]

   assessed using circumference measurements (cm)

Secondary Outcome Measures

1. Change in Peak Torque When Doing Leg Extensions [Post-12 week intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State University	Phoenix	Arizona	United States	85004

Sponsors and Collaborators

• Point Loma Nazarene University

Investigators

• Principal Investigator: Heidi Lynch, PhD, Point Loma Nazarene University

Study Documents (Full-Text)

• Study Protocol - Aug 1, 2016
• Statistical Analysis Plan - Aug 1, 2016
• Informed Consent Form - Jan 27, 2017

More Information

Publications

None provided.

• Responsible Party: Heidi Lynch, Assistant Professor, Point Loma Nazarene University
• ClinicalTrials.gov Identifier: NCT03868631
• Other Study ID Numbers: 01435225
• First Posted: Mar 11, 2019
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

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.

Arm/Group Title	Soy Protein Group	Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Period Title: Baseline to Week 6
STARTED	30	31
COMPLETED	26	27
NOT COMPLETED	4	4
Period Title: Baseline to Week 6
STARTED	26	27
COMPLETED	22	26
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Soy Protein Group	Whey Protein Group	Total
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.	Total of all reporting groups
Overall Participants	30	31	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.83 (4.27)	22.22 (3.38)	22.03 (3.81)
Sex: Female, Male (Count of Participants)
Female	21 70%	21 67.7%	42 68.9%
Male	9 30%	10 32.3%	19 31.1%
Race/Ethnicity, Customized (Count of Participants)
White	21 70%	18 58.1%	39 63.9%
Non-white	9 30%	13 41.9%	22 36.1%
Region of Enrollment (Count of Participants)
United States	30 100%	31 100%	61 100%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	166.93 (10.03)	168.20 (7.04)	167.57 (8.59)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	65.5 (13.3)	66.9 (10.1)	66.26 (11.61)
Lean body mass (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	44.084 (10.2896)	44.486 (8.7167)	44.301 (9.3816)
Appendicular lean body mass (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	19.81796 (5.353628)	20.32806 (5.096195)	20.09263 (5.171179)
Fat mass (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	19.71463 (6.818858)	20.21259 (6.261987)	19.97825 (6.468543)
Body fat percent (percent body fat) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent body fat]	30.92083 (8.227645)	31.38214 (8.163188)	31.16923 (8.115504)
Vastus lateralis thickness (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	2.167615 (0.3136369)	2.330765 (0.5032904)	2.253989 (0.4286374)
Vastus intermedius thickness (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	1.563921 (0.3433793)	1.572045 (0.4095149)	1.568222 (0.3761121)
Peak torque doing leg extensions (60 d/s) (Newton-meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Newton-meters]	132.0228 (44.87827)	124.3479 (39.91502)	127.8901 (42.03202)
Peak torque doing leg flexions (60 d/s) (Newton-meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Newton-meters]	64.2884 (15.04077)	60.4792 (15.85495)	62.2373 (15.45260)

Outcome Measures

1. Primary Outcome

Title	Lean Body Mass Change
Description	assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)
Time Frame	Post-12 week intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soy Protein Group	Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Measure Participants	30	31
Mean (Standard Deviation) [kilogram]	1.5 (0.4)	1.3 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Soy Protein Group, Whey Protein Group
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	multilevel models for change
	Comments

2. Primary Outcome

Title	Muscle Tissue Thickness Change
Description	assessed using changes in muscle thickness assessed by ultrasound (cm)
Time Frame	Post-12 week intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soy Protein Group	Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Measure Participants	30	31
Mean (Standard Deviation) [centimeter]	0.12 (0.16)	0.05 (0.41)

3. Primary Outcome

Title	Leg Girth Changes
Description	assessed using circumference measurements (cm)
Time Frame	Post-12 week intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soy Protein Group	Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Measure Participants	30	31
Mean (Standard Deviation) [centimeter]	-0.1865 (0.05254)	-0.0084 (0.06227)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soy Protein Group	Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.	Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
Measure Participants	30	31
Mean (Standard Deviation) [Newton-meters]	12.1 (13.5)	18.0 (16.1)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Soy Protein Group		Whey Protein Group
Arm/Group Description	Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.		Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
All Cause Mortality
	Soy Protein Group		Whey Protein Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Serious Adverse Events
	Soy Protein Group		Whey Protein Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Soy Protein Group		Whey Protein Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/30 (6.7%)		3/31 (9.7%)
Gastrointestinal disorders
Abdominal pain	0/30 (0%)	0	1/31 (3.2%)	1
Vomited	0/30 (0%)	0	1/31 (3.2%)	1
Musculoskeletal and connective tissue disorders
Hip pain	1/30 (3.3%)	1	0/31 (0%)	0
Knee pain	0/30 (0%)	0	1/31 (3.2%)	1
Knee pain	1/30 (3.3%)	1	0/31 (0%)	0

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.