Status:
COMPLETED
Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Age-Related Sarcopenia
Muscle Loss
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 postm...
Detailed Description
With aging, skeletal muscle mass and performance decline leading to an increased risk of falls and physical disability. There is ongoing research on whether increasing dietary protein intake in older ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04048616
Start Date
July 1 2021
End Date
December 21 2023
Last Update
May 18 2025
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111