Trial Outcomes & Findings for Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults (NCT NCT04048616)
NCT ID: NCT04048616
Last Updated: 2025-05-18
Results Overview
Double leg press peak power at 70% of the 1 repetition maximum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-05-18
Participant Flow
From July 2021 to July 2023, ambulatory, community-dwelling men and postmenopausal women aged 65 years and older were recruited from direct mailings to the HNRCA volunteer database and the Tufts Medical Center patient database.
Exclusion criteria included use of oral glucocorticoids, anabolic and gonadal hormones, alkali-producing antacids, potassium-containing supplements, insulin, uncontrolled diabetes mellitus, kidney stones, advanced chronic kidney disease, cirrhosis, gastroesophageal or intestinal disease, immune disorders, unstable heart disease, untreated thyroid or parathyroid disease, active malignancy or cancer therapy, recent fracture, milk protein allergy, and relevant laboratory abnormalities.
Participant milestones
| Measure |
Whey Protein Isolate + KHCO3
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
|
Whey Protein Isolate + Microcrystalline Cellulose
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
microcrystalline cellulose: identical placebo capsule
|
Maltodextrin Powder + KHCO3
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
maltodextrin powder: isocaloric placebo powder
|
Maltodextrin Powder + Microcrystalline Cellulose
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
microcrystalline cellulose: identical placebo capsule
maltodextrin powder: isocaloric placebo powder
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
32
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Baseline characteristics by cohort
| Measure |
Whey Protein Isolate + KHCO3
n=29 Participants
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
|
Whey Protein Isolate + Microcrystalline Cellulose
n=34 Participants
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
microcrystalline cellulose: identical placebo capsule
|
Maltodextrin Powder + KHCO3
n=31 Participants
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
maltodextrin powder: isocaloric placebo powder
|
Maltodextrin Powder + Microcrystalline Cellulose
n=34 Participants
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
microcrystalline cellulose: identical placebo capsule
maltodextrin powder: isocaloric placebo powder
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
128 Participants
n=36 Participants
|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
74.5 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
74.1 years
STANDARD_DEVIATION 5.3 • n=27 Participants
|
72.7 years
STANDARD_DEVIATION 5.5 • n=483 Participants
|
74.1 years
STANDARD_DEVIATION 5.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
67 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
126 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
107 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
34 participants
n=4 Participants
|
31 participants
n=27 Participants
|
34 participants
n=483 Participants
|
128 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Double leg press peak power at 70% of the 1 repetition maximum
Outcome measures
| Measure |
Whey Protein (WP)
n=59 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=61 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=60 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Double Leg Press Peak Power at 70%
|
260.3 Watts
Interval 241.9 to 278.7
|
255.6 Watts
Interval 237.5 to 273.7
|
251.1 Watts
Interval 232.9 to 269.3
|
264.8 Watts
Interval 246.4 to 283.1
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Double leg press peak power at 70% of the 1-repetition maximum
Outcome measures
| Measure |
Whey Protein (WP)
n=60 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=62 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=59 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Double Leg Press Peak Power at 70%
|
252.8 Watts
Interval 233.4 to 272.2
|
253.8 Watts
Interval 234.8 to 272.8
|
246.9 Watts
Interval 227.4 to 266.4
|
259.7 Watts
Interval 240.8 to 278.7
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Double leg press peak power at 40% of the 1 repetition maximum
Outcome measures
| Measure |
Whey Protein (WP)
n=59 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=61 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Double Leg Press Peak Power at 40%
|
223.8 Watts
Interval 200.4 to 247.3
|
219.5 Watts
Interval 196.5 to 242.6
|
225.3 Watts
Interval 202.0 to 248.5
|
218.1 Watts
Interval 194.6 to 241.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Double leg press peak power at 40% of the 1 repetition maximum
Outcome measures
| Measure |
Whey Protein (WP)
n=60 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=63 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Double Leg Press Peak Power at 40%
|
221.9 Watts
Interval 199.5 to 244.3
|
215.8 Watts
Interval 193.8 to 237.7
|
220.7 Watts
Interval 188.3 to 253.1
|
215.3 Watts
Interval 192.7 to 237.8
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Outcome measures
| Measure |
Whey Protein (WP)
n=61 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=62 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Knee Extension Peak Torque
|
99.5 Newton-meters
Interval 95.6 to 103.3
|
101.5 Newton-meters
Interval 97.7 to 105.3
|
102.4 Newton-meters
Interval 98.5 to 106.2
|
98.6 Newton-meters
Interval 94.8 to 102.4
|
SECONDARY outcome
Timeframe: 12 weeksKnee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Outcome measures
| Measure |
Whey Protein (WP)
n=63 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=65 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=68 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Knee Extension Peak Torque
|
96.2 Newton-meters
Interval 92.6 to 99.8
|
100.8 Newton-meters
Interval 97.4 to 104.3
|
95.2 Newton-meters
Interval 87.2 to 103.2
|
97.7 Newton-meters
Interval 94.1 to 101.3
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Measure maximum handgrip strength in either hand using handheld Jamar+ dynamometer
Outcome measures
| Measure |
Whey Protein (WP)
n=61 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=62 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Handgrip Strength
|
29.0 kg
Interval 27.8 to 30.1
|
28.3 kg
Interval 27.2 to 29.4
|
28.7 kg
Interval 26.7 to 29.8
|
28.5 kg
Interval 27.4 to 29.6
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared
Outcome measures
| Measure |
Whey Protein (WP)
n=60 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=62 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=62 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Appendicular Lean Body Mass/Height Squared
|
7.0 kg/m^2
Interval 6.9 to 7.1
|
7.1 kg/m^2
Interval 7.0 to 7.1
|
7.0 kg/m^2
Interval 6.9 to 7.1
|
7.1 kg/m^2
Interval 7.0 to 7.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Performance score (range 0-4 with higher values representing a better performance) based on Health Aging and Body Composition-Physical Performance Battery
Outcome measures
| Measure |
Whey Protein (WP)
n=61 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=62 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
Physical Performance Battery Score
|
2.1 score on a scale
Interval 2.0 to 2.2
|
2.2 score on a scale
Interval 2.1 to 2.3
|
2.2 score on a scale
Interval 2.1 to 2.3
|
2.1 score on a scale
Interval 2.1 to 2.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
Measure based on 24 hour urine total nitrogen excretion
Outcome measures
| Measure |
Whey Protein (WP)
n=61 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=63 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=60 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
24 Hour Urinary Total Nitrogen Excretion
|
13.1 g
Interval 12.2 to 14.0
|
9.8 g
Interval 8.9 to 10.7
|
11.2 g
Interval 10.3 to 12.1
|
11.7 g
Interval 10.9 to 12.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: Analysis used an at-the-margins approach to evaluate the superiority of whey protein (WP) against placebo-WP and of potassium bicarbonate (KHCO3) against placebo-KHCO3
measure of total body percent muscle mass by D3-creatine dilution method
Outcome measures
| Measure |
Whey Protein (WP)
n=57 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=58 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=55 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=60 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
D3-creatine Muscle Mass/Weight
|
27.9 percentage of muscle mass
Interval 27.1 to 28.8
|
29.1 percentage of muscle mass
Interval 28.3 to 29.9
|
28.9 percentage of muscle mass
Interval 28.1 to 29.7
|
28.1 percentage of muscle mass
Interval 27.3 to 29.0
|
POST_HOC outcome
Timeframe: 24 weeksSerum insulin-like growth factor 1 (IGF-1) level
Outcome measures
| Measure |
Whey Protein (WP)
n=61 Participants
Combined participants assigned to the WP + potassium bicarbonate (KHCO3) group and the WP + microcrystalline cellulose placebo
|
Placebo-WP
n=61 Participants
Combined participants assigned to the maltodextrin + KHCO3 group and the maltodextrin + microcrystalline cellulose placebo group
|
Potassium Bicarbonate (KHCO3)
n=59 Participants
Combined participants assigned to the KHCO3 + WP group and the KHCO3 + maltodextrin placebo
|
Placebo-KHCO3
n=63 Participants
Combined participants assigned to the microcrystalline cellulose placebo + WP group and the microcrystalline cellulose placebo + maltodextrin placebo group
|
|---|---|---|---|---|
|
IGF-1
|
118.5 ng/mL
Interval 113.8 to 123.3
|
104.3 ng/mL
Interval 99.6 to 109.0
|
115.0 ng/mL
Interval 110.2 to 119.8
|
107.8 ng/mL
Interval 103.2 to 112.5
|
Adverse Events
Whey Protein Isolate + KHCO3
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Whey Protein Isolate + Microcrystalline Cellulose
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Maltodextrin Powder + KHCO3
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Maltodextrin Powder + Microcrystalline Cellulose
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Whey Protein Isolate + KHCO3
n=35 participants at risk
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
|
Whey Protein Isolate + Microcrystalline Cellulose
n=36 participants at risk
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
microcrystalline cellulose: identical placebo capsule
|
Maltodextrin Powder + KHCO3
n=35 participants at risk
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
maltodextrin powder: isocaloric placebo powder
|
Maltodextrin Powder + Microcrystalline Cellulose
n=35 participants at risk
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
microcrystalline cellulose: identical placebo capsule
maltodextrin powder: isocaloric placebo powder
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Vascular disorders
Cardiovascular event
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
5.7%
2/35 • Number of events 2 • up to 24 weeks
Standard definitions
|
|
Musculoskeletal and connective tissue disorders
Fall with musculoskeletal complication
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
Peptic ulcer
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
Other adverse events
| Measure |
Whey Protein Isolate + KHCO3
n=35 participants at risk
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
|
Whey Protein Isolate + Microcrystalline Cellulose
n=36 participants at risk
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal
microcrystalline cellulose: identical placebo capsule
|
Maltodextrin Powder + KHCO3
n=35 participants at risk
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal
maltodextrin powder: isocaloric placebo powder
|
Maltodextrin Powder + Microcrystalline Cellulose
n=35 participants at risk
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
microcrystalline cellulose: identical placebo capsule
maltodextrin powder: isocaloric placebo powder
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pedal edema
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
5.7%
2/35 • Number of events 2 • up to 24 weeks
Standard definitions
|
|
Cardiac disorders
Myocardial infaction
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Cardiac disorders
coronary heart disease
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Ear and labyrinth disorders
Benign Positional Vertgo
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
5.6%
2/36 • Number of events 2 • up to 24 weeks
Standard definitions
|
11.4%
4/35 • Number of events 4 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.6%
3/35 • Number of events 3 • up to 24 weeks
Standard definitions
|
8.3%
3/36 • Number of events 3 • up to 24 weeks
Standard definitions
|
14.3%
5/35 • Number of events 6 • up to 24 weeks
Standard definitions
|
8.6%
3/35 • Number of events 3 • up to 24 weeks
Standard definitions
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infections
|
20.0%
7/35 • Number of events 7 • up to 24 weeks
Standard definitions
|
11.1%
4/36 • Number of events 4 • up to 24 weeks
Standard definitions
|
14.3%
5/35 • Number of events 5 • up to 24 weeks
Standard definitions
|
8.6%
3/35 • Number of events 3 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
GERD
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
Peptic ulcer
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Musculoskeletal and connective tissue disorders
Fall with injury
|
8.6%
3/35 • Number of events 3 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
General disorders
Leg cramps
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell cancer
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Psychiatric disorders
Depression
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Renal and urinary disorders
Prostate problems
|
5.7%
2/35 • Number of events 2 • up to 24 weeks
Standard definitions
|
2.8%
1/36 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
Vascular disorders
cerebrovascular event
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
General disorders
Dental infection
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
|
Gastrointestinal disorders
Food poisoning
|
5.7%
2/35 • Number of events 2 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
General disorders
Hyperkalemia
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
|
General disorders
Lightheadedness
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
0.00%
0/36 • up to 24 weeks
Standard definitions
|
2.9%
1/35 • Number of events 1 • up to 24 weeks
Standard definitions
|
0.00%
0/35 • up to 24 weeks
Standard definitions
|
Additional Information
Lisa Ceglia, MD MS
Tufts University and Tufts Medical Center
Phone: (617) 636-8171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place