Trial Outcomes & Findings for Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults (NCT NCT00635739)
NCT ID: NCT00635739
Last Updated: 2019-03-18
Results Overview
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline and follow up (6 months)
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
Whey Protein
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
Baseline characteristics by cohort
| Measure |
A,1 (Intervention)
n=42 Participants
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
A,2 (Control)
n=38 Participants
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
77.3 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
38 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and follow up (6 months)Population: 5 subjects were not included in follow up analysis
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
Outcome measures
| Measure |
Whey Protein
n=42 Participants
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo
n=38 Participants
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
|---|---|---|
|
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Baseline
|
1223 N
Standard Deviation 380
|
1256 N
Standard Deviation 461
|
|
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Follow up
|
1483 N
Standard Deviation 517
|
1465 N
Standard Deviation 528
|
SECONDARY outcome
Timeframe: Baseline and follow up (6 months)Population: 5 subjects were not included in follow up analysis
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Outcome measures
| Measure |
Whey Protein
n=42 Participants
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo
n=38 Participants
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
|---|---|---|
|
Lean Mass
Baseline
|
46.7 Kg
Standard Deviation 8.6
|
46.4 Kg
Standard Deviation 8.4
|
|
Lean Mass
Follow up
|
47.3 Kg
Standard Deviation 8.6
|
46.7 Kg
Standard Deviation 8.4
|
Adverse Events
Whey Protein
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Whey Protein
n=42 participants at risk
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo
n=38 participants at risk
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
4.8%
2/42 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
fall
|
2.4%
1/42 • 6 months
|
2.6%
1/38 • 6 months
|
|
General disorders
hospitalization
|
7.1%
3/42 • 6 months
|
2.6%
1/38 • 6 months
|
Other adverse events
| Measure |
Whey Protein
n=42 participants at risk
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo
n=38 participants at risk
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
|
|---|---|---|
|
Gastrointestinal disorders
GI distress
|
9.5%
4/42 • Number of events 4 • 6 months
|
5.3%
2/38 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/42 • 6 months
|
5.3%
2/38 • Number of events 2 • 6 months
|
|
Surgical and medical procedures
Surgery
|
2.4%
1/42 • Number of events 1 • 6 months
|
13.2%
5/38 • Number of events 5 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.4%
1/42 • Number of events 1 • 6 months
|
7.9%
3/38 • Number of events 3 • 6 months
|
|
General disorders
Laboratory
|
7.1%
3/42 • Number of events 3 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
General disorders
Illness
|
11.9%
5/42 • Number of events 5 • 6 months
|
15.8%
6/38 • Number of events 6 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place