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| Name | Class |
|---|---|
| National Dairy Council | OTHER |
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This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, 1 | Active Comparator |
| |
| A, 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | powdered, 46g supplement dissolved in fluids, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment. | Baseline and follow up (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Lean Mass | Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry. | Baseline and follow up (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger A Fielding, Ph.D. | Jean Mayer USDA Human Nutrition Research Center on Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23114462 | Derived | Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA. Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):682-90. doi: 10.1093/gerona/gls221. Epub 2012 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Whey Protein | Whey protein: powdered, 46g supplement dissolved in fluids, twice daily |
| FG001 | Placebo | Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A,1 (Intervention) | Whey protein: powdered, 46g supplement dissolved in fluids, twice daily |
| BG001 | A,2 (Control) | Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment. | 5 subjects were not included in follow up analysis | Posted | Mean | Standard Deviation | N | Baseline and follow up (6 months) |
|
6 months
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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 | Whey Protein | Whey protein: powdered, 46g supplement dissolved in fluids, twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI distress | Gastrointestinal disorders | Systematic Assessment | GI upset |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Fielding | Tufts University | 6175563083 | Roger.Fielding@tufts.edu |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Maltodextrin placebo |
| Dietary Supplement |
powdered, 46g supplement dissolved in fluids, twice daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Lean Mass | Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry. | 5 subjects were not included in follow up analysis | Posted | Mean | Standard Deviation | Kg | Baseline and follow up (6 months) |
|
|
|
| 6 |
| 42 |
| 14 |
| 42 |
| EG001 | Placebo | Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily | 3 | 38 | 19 | 38 |
| fall | General disorders | Systematic Assessment |
|
| hospitalization | General disorders | Systematic Assessment | Hospitalization reason is not know. |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-injurious fall |
|
| Surgery | Surgical and medical procedures | Systematic Assessment | Outpatient surgical procedure |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Musculoskeletal pain/injury |
|
| Laboratory | General disorders | Systematic Assessment | Abnormal laboratory value |
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| Illness | General disorders | Systematic Assessment | Illness that would restrict physical activity |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| Follow up |
|
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