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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Age-Related Sarcopenia Muscle Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

double blind randomized placebo controlled 2x2 factorial design

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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whey protein isolate + KHCO3

1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3

Group Type ACTIVE_COMPARATOR

whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

one 15-25 gm (based on body weight) protein packet three times a day with each meal

potassium bicarbonate (KHCO3)

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

one 15-25 gm (based on body weight) protein packet three times a day with each meal

microcrystalline cellulose

Intervention Type OTHER

identical placebo capsule

maltodextrin powder + KHCO3

isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3

Group Type ACTIVE_COMPARATOR

potassium bicarbonate (KHCO3)

Intervention Type DIETARY_SUPPLEMENT

two 13.5 mmol capsules three times a day with each meal

maltodextrin powder

Intervention Type OTHER

isocaloric placebo powder

maltodextrin powder + microcrystalline cellulose

isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Group Type PLACEBO_COMPARATOR

microcrystalline cellulose

Intervention Type OTHER

identical placebo capsule

maltodextrin powder

Intervention Type OTHER

isocaloric placebo powder

Interventions

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whey protein isolate

one 15-25 gm (based on body weight) protein packet three times a day with each meal

Intervention Type DIETARY_SUPPLEMENT

potassium bicarbonate (KHCO3)

two 13.5 mmol capsules three times a day with each meal

Intervention Type DIETARY_SUPPLEMENT

microcrystalline cellulose

identical placebo capsule

Intervention Type OTHER

maltodextrin powder

isocaloric placebo powder

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes