Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults

Not Applicable

Completed

• Conditions: Age-Related Sarcopenia; Muscle Loss
• Interventions: Dietary Supplement: whey protein isolate; Other: maltodextrin powder; Other: microcrystalline cellulose; Dietary Supplement: potassium bicarbonate (KHCO3)

• Registration Number: NCT04048616
• Lead Sponsor: Tufts University

Brief Summary

Whether higher dietary protein benefits skeletal muscle health in older adults remains an ongoing area of investigation. This study will determine whether adding an alkaline salt supplement, potassium bicarbonate, to reduce the dietary acid load of a high protein diet can further enhance the beneficial impact of a high protein diet alone on muscle performance and mass in older underactive adults on baseline low protein diet.

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 plus a neutralizing alkaline salt will have additive effects on muscle performance and mass in older adults to either intervention alone. To test the hypothesis, the investigators will conduct a randomized, double-blind, placebo-controlled, 2x2 factorial study in which underactive men and women age 65 and older on baseline lower protein diets will be enrolled. Participants will 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. The primary outcome is lower extremity muscle power at 24 weeks. Secondary outcomes are lower extremity muscle power at 12 weeks, muscle endurance at 12 and 24 weeks, physical performance at 24 weeks, lean mass at 24 weeks, and 24-hr urinary nitrogen excretion adjusted for nitrogen intake at 24 weeks. Exploratory outcomes will include a measure of muscle mass - D3-creatine dilution - and how it correlates with lean mass. Changes in these outcomes will be compared in the 4 groups. If successful, this research would represent a meaningful step in defining the circumstances under which protein has its greatest anabolic benefit.

Study Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-11-01
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
maltodextrin powder + microcrystalline cellulose	maltodextrin powder	isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
whey protein isolate + KHCO3	whey protein isolate	1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate + microcrystalline cellulose	microcrystalline cellulose	1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
maltodextrin powder + KHCO3	maltodextrin powder	isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
whey protein isolate + KHCO3	potassium bicarbonate (KHCO3)	1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
whey protein isolate + microcrystalline cellulose	whey protein isolate	1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
maltodextrin powder + KHCO3	potassium bicarbonate (KHCO3)	isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
maltodextrin powder + microcrystalline cellulose	microcrystalline cellulose	isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Primary Outcome Measures

Name	Time	Method
lower extremity muscle power	24 weeks	measure of muscle power using a double leg press

Secondary Outcome Measures

Name	Time	Method
appendicular lean body mass	24 weeks	Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared
lower extremity muscle power	12 weeks	measure muscle power using double leg press
isokinetic leg extension strength and endurance	12 and 24 weeks	measure knee extension strength, torque and fatigability using Biodex Isokinetic Dynamometer
physical performance battery	24 weeks	measure performance based on Health Aging and Body Composition-Physical Performance Battery
handgrip strength	24 weeks	measure strength using grip strength dynamometer
24 hour urinary nitrogen excretion to nitrogen intake	24 weeks	measure based on 24 hour urine and 24 hour diet recall

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States