N/A
N=141
Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Age-Related Sarcopenia · Muscle Loss
Bottom Line
View on ClinicalTrials.gov: NCT04048616 ↗Enrolled (actual)
141
Serious AEs
7.8%
Results posted
May 2025
Primary outcome: Primary: Double Leg Press Peak Power at 70% — 260.3; 255.6; 251.1; 264.8 Watts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- whey protein isolate (Dietary_supplement); potassium bicarbonate (KHCO3) (Dietary_supplement); microcrystalline cellulose (Other); maltodextrin powder (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double Leg Press Peak Power at 70% |
252.8; 253.8; 246.9; 259.7 | — |
| SECONDARY Double Leg Press Peak Power at 70% |
252.8; 253.8; 246.9; 259.7 | — |
| SECONDARY Double Leg Press Peak Power at 40% |
221.9; 215.8; 220.7; 215.3 | — |
| SECONDARY Double Leg Press Peak Power at 40% |
221.9; 215.8; 220.7; 215.3 | — |
| SECONDARY Knee Extension Peak Torque |
96.2; 100.8; 95.2; 97.7 | — |
| SECONDARY Knee Extension Peak Torque |
96.2; 100.8; 95.2; 97.7 | — |
| SECONDARY Handgrip Strength |
29.0; 28.3; 28.7; 28.5 | — |
| SECONDARY Appendicular Lean Body Mass/Height Squared |
7.0; 7.1; 7.0; 7.1 | — |
| SECONDARY Physical Performance Battery Score |
2.1; 2.2; 2.2; 2.1 | — |
| SECONDARY 24 Hour Urinary Total Nitrogen Excretion |
13.1; 9.8; 11.2; 11.7 | — |
Summary
The central hypothesis is that higher protein intake and a neutralizing alkaline salt supplement will improve muscle performance and mass, compared to their respective placebos, in older men and postmenopausal women.
Eligibility Criteria
Inclusion Criteria
- ability to sign informed consent form
- ambulatory community-dwelling men and women
- age 65 years and over
- habitual dietary intake of protein of ≤0.8 g/kg/d
- underactive
- estimated glomerular filtration rate ≥ 50 ml/min/1.73 m2
Exclusion Criteria
- participation in a diet or intensive exercise program during the study
- vegetarian (no animal protein)
- oral glucocorticoid use for > 10 days in the last 3 months
- anabolic and gonadal hormones in the last 6 months
- Tamoxifen/raloxifene in the last 6 months
- regular use of alkali-producing antacids (> 3 times per week)
- potassium-containing supplements or products
- non-steroidal anti-inflammatory medications >3 times per week
- antacids containing calcium carbonate, aluminum hydroxide, magnesium hydroxide, or calcium acetate
- insulin
- sulfonylureas
- SGLT2 inhibitors
- a lower extremity fracture in the last year
- kidney stones in the past 5 years
- hyperkalemia
- elevated serum bicarbonate
- hypercalcemia
- uncontrolled diabetes mellitus defined as having fasting blood >150 or hemoglobin A1c >8%
- untreated thyroid or parathyroid disease
- significant immune disorder
- current unstable heart disease
- Crohn's disease
- active malignancy or cancer therapy in the last year
- alcohol use exceeding 2 drinks/day
- current peptic ulcers or esophageal stricture
- other condition or abnormality in screening labs, at discretion of the study physician
Data sourced from ClinicalTrials.gov (NCT04048616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.