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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy protein group | Active Comparator |
| |
| Whey protein group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein supplement | Dietary Supplement | 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Torque When Doing Leg Extensions | Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s) | Post-12 week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Lynch, PhD | Point Loma Nazarene University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Soy Protein Group | Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group. |
| FG001 | Whey Protein Group | Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Week 6 |
|
| |||||||||||||||||||||
| Week 6 to Week 12 (Study Completion) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soy Protein Group | Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group. |
| BG001 | Whey Protein Group | Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lean Body Mass Change | assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg) | Posted | Mean | Standard Deviation | kilogram | Post-12 week intervention |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soy Protein Group | Soy protein supplement: 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip pain | Musculoskeletal and connective tissue disorders | hip pain | Systematic Assessment | Week 6-week 12 |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Lynch | Point Loma Nazarene University | 619-806-3306 | hlynch@pointloma.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2016 | Feb 19, 2020 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2016 | Feb 19, 2020 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2017 | Feb 19, 2020 | ICF_006.pdf |
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| Soy protein supplement | Dietary Supplement | 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group. |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Lean body mass | Mean | Standard Deviation | kilograms |
|
| Appendicular lean body mass | Mean | Standard Deviation | kilograms |
|
| Fat mass | Mean | Standard Deviation | kilograms |
|
| Body fat percent | Mean | Standard Deviation | percent body fat |
|
| Vastus lateralis thickness | Mean | Standard Deviation | centimeters |
|
| Vastus intermedius thickness | Mean | Standard Deviation | centimeters |
|
| Peak torque doing leg extensions (60 d/s) | Mean | Standard Deviation | Newton-meters |
|
| Peak torque doing leg flexions (60 d/s) | Mean | Standard Deviation | Newton-meters |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Muscle Tissue Thickness Change | assessed using changes in muscle thickness assessed by ultrasound (cm) | Posted | Mean | Standard Deviation | centimeter | Post-12 week intervention |
|
|
|
| Primary | Leg Girth Changes | assessed using circumference measurements (cm) | Posted | Mean | Standard Deviation | centimeter | Post-12 week intervention |
|
|
|
| Secondary | Change in Peak Torque When Doing Leg Extensions | Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s) | Posted | Mean | Standard Deviation | Newton-meters | Post-12 week intervention |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Whey Protein Group | Whey protein supplement: 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group. | 0 | 31 | 0 | 31 | 3 | 31 |
|
| Abdominal pain | Gastrointestinal disorders | Abdominal pain | Systematic Assessment | Baseline-week 6 |
|
| Vomited | Gastrointestinal disorders | Vomited | Systematic Assessment | Baseline-week 6 |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Knee pain | Systematic Assessment | Baseline-week 6 |
|
| Knee pain | Musculoskeletal and connective tissue disorders | knee pain | Systematic Assessment | Week 6-week 12 |
|
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