Clinical trial NCT04048616: Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Official title: Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Sarcopenia
Muscle Loss
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-07
Enrollment: 141
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: double blind randomized placebo controlled 2x2 factorial design
Primary purpose: PREVENTION

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 postmenopausal women.

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 adults improves indices of muscle health and thus translates to a reduction in physical disability. A main concern is that high protein results in a large dietary acid load from the breakdown of protein to acidogenic byproducts, which could in turn promote muscle degradation particularly in older adults with age-related declines in renal excretion of acid. The scientific premise of this project is that the balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on muscle. Preliminary data have suggested that a daily alkaline salt supplement (potassium bicarbonate, KHCO3) lowered the dietary acid load and improved lower extremity muscle power in postmenopausal women.

The investigator's central hypothesis is that higher protein intake and a neutralizing alkaline salt will improve muscle performance and mass, compared to their respective placebos, in older men and postmenopausal women. To test the hypothesis, the investigators conducted a randomized, double-blind, placebo-controlled, 2x2 factorial study in underactive men and women age 65 and older on baseline lower protein diets. Participants were assigned to one of four groups: either a whey protein supplement (to raise protein intake to 1.5 g/kg/d) with or without KHCO3 81 mmol/d or an isocaloric placebo supplement with or without KHCO3 81 mmol/d for 24 wks.

Eligibility criteria: Inclusion Criteria:

1. ability to sign informed consent form
2. ambulatory community-dwelling men and women
3. age 65 years and over
4. habitual dietary intake of protein of ≤0.8 g/kg/d
5. underactive
6. estimated glomerular filtration rate ≥ 50 ml/min/1.73 m2

Exclusion Criteria:

1. participation in a diet or intensive exercise program during the study
2. vegetarian (no animal protein)
3. oral glucocorticoid use for \> 10 days in the last 3 months
4. anabolic and gonadal hormones in the last 6 months
5. Tamoxifen/raloxifene in the last 6 months
6. regular use of alkali-producing antacids (\> 3 times per week)
7. potassium-containing supplements or products
8. non-steroidal anti-inflammatory medications \>3 times per week
9. antacids containing calcium carbonate, aluminum hydroxide, magnesium hydroxide, or calcium acetate
10. insulin
11. sulfonylureas
12. SGLT2 inhibitors
13. a lower extremity fracture in the last year
14. kidney stones in the past 5 years
15. hyperkalemia
16. elevated serum bicarbonate
17. hypercalcemia
18. uncontrolled diabetes mellitus defined as having fasting blood \>150 or hemoglobin A1c \>8%
19. untreated thyroid or parathyroid disease
20. significant immune disorder
21. current unstable heart disease
22. Crohn's disease
23. active malignancy or cancer therapy in the last year
24. alcohol use exceeding 2 drinks/day
25. current peptic ulcers or esophageal stricture
26. other condition or abnormality in screening labs, at discretion of the study physician

Primary outcomes:
measure: Double Leg Press Peak Power at 70%
timeFrame: 24 weeks
Secondary outcomes:
measure: Double Leg Press Peak Power at 70%
timeFrame: 12 weeks
measure: Double Leg Press Peak Power at 40%
timeFrame: 24 weeks
measure: Double Leg Press Peak Power at 40%
timeFrame: 12 weeks
measure: Knee Extension Peak Torque
timeFrame: 24 weeks
measure: Knee Extension Peak Torque
timeFrame: 12 weeks
measure: Handgrip Strength
timeFrame: 24 weeks
measure: Appendicular Lean Body Mass/Height Squared
timeFrame: 24 weeks
measure: Physical Performance Battery Score
timeFrame: 24 weeks
measure: 24 Hour Urinary Total Nitrogen Excretion
timeFrame: 24 weeks
Other outcomes:
measure: D3-creatine Muscle Mass/Weight
timeFrame: 24 weeks
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center and Tufts University
name: Lisa Ceglia, MD MS
role: PRINCIPAL_INVESTIGATOR
References: