Mobility Limitation
Conditions
Keywords
Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults, Mobility-Limited
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTWhey protein
powdered, 46g supplement dissolved in fluids, twice daily
DIETARY_SUPPLEMENTMaltodextrin placebo
powdered, 46g supplement dissolved in fluids, twice daily
Sponsors
National Dairy Council
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and Females 70-85 yrs * Community dwelling * Short Physical Performance Battery score \< 10 * BMI = 21-32.5
Exclusion criteria
* Acute or terminal illness * Mini Mental State Exam \< 23 * Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure * Upper or lower extremity fracture in previous 6 months * Uncontrolled hypertension (\>150/90 mm Hg). * Neuromuscular diseases and drugs which affect neuromuscular function. * Hormone replacement therapy * eGFR \<30 mL/min/1.73m2 * Types I and II Diabetes Mellitus * Dietary protein intake \< 0.8 g.kg-1.day-1 * Disorders of nutrient absorption * Milk, or whey allergy * Sulfa drugs and allergy to PABA-containing sunscreens
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | Baseline and follow up (6 months) | The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Mass | Baseline and follow up (6 months) | Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A,1 (Intervention) Whey protein: powdered, 46g supplement dissolved in fluids, twice daily | 42 |
| A,2 (Control) Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily | 38 |
| Total | 80 |
Baseline characteristics
| Characteristic | A,2 (Control) | A,1 (Intervention) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 42 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 77.3 years STANDARD_DEVIATION 3.9 | 78.0 years STANDARD_DEVIATION 4 | 77.7 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 38 participants | 42 participants | 80 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 42 | 19 / 38 |
| serious Total, serious adverse events | 6 / 42 | 3 / 38 |
Outcome results
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.
Time frame: Baseline and follow up (6 months)
Population: 5 subjects were not included in follow up analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whey Protein | 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | Baseline | 1223 N | Standard Deviation 380 |
| Whey Protein | 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | Follow up | 1483 N | Standard Deviation 517 |
| Placebo | 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | Baseline | 1256 N | Standard Deviation 461 |
| Placebo | 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | Follow up | 1465 N | Standard Deviation 528 |
Secondary
Lean Mass
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Time frame: Baseline and follow up (6 months)
Population: 5 subjects were not included in follow up analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whey Protein | Lean Mass | Baseline | 46.7 Kg | Standard Deviation 8.6 |
| Whey Protein | Lean Mass | Follow up | 47.3 Kg | Standard Deviation 8.6 |
| Placebo | Lean Mass | Baseline | 46.4 Kg | Standard Deviation 8.4 |
| Placebo | Lean Mass | Follow up | 46.7 Kg | Standard Deviation 8.4 |