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Completed

NCT Number: NCT04048616

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein isolate

Dietary Supplement

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

potassium bicarbonate (KHCO3)

Dietary Supplement

two 13.5 mmol capsules three times a day with each meal

Microcrystalline Cellulose

Other

identical placebo capsule

Maltodextrin powder

Other

isocaloric placebo powder

Primary outcomes

  1. Double Leg Press Peak Power at 70%

    Time frame: 24 weeks

    Double leg press peak power at 70% of the 1 repetition maximum

Secondary outcomes

  1. Double Leg Press Peak Power at 70%

    Time frame: 12 weeks

    Double leg press peak power at 70% of the 1-repetition maximum

  2. Double Leg Press Peak Power at 40%

    Time frame: 24 weeks

    Double leg press peak power at 40% of the 1 repetition maximum

  3. Double Leg Press Peak Power at 40%

    Time frame: 12 weeks

    Double leg press peak power at 40% of the 1 repetition maximum

  4. Knee Extension Peak Torque

    Time frame: 24 weeks

    Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer

  5. Knee Extension Peak Torque

    Time frame: 12 weeks

    Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer

  6. Handgrip Strength

    Time frame: 24 weeks

    Measure maximum handgrip strength in either hand using handheld Jamar+ dynamometer

  7. Appendicular Lean Body Mass/Height Squared

    Time frame: 24 weeks

    Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared

  8. Physical Performance Battery Score

    Time frame: 24 weeks

    Performance score (range 0-4 with higher values representing a better performance) based on Health Aging and Body Composition-Physical Performance Battery

  9. 24 Hour Urinary Total Nitrogen Excretion

    Time frame: 24 weeks

    Measure based on 24 hour urine total nitrogen excretion

Other outcomes

  1. D3-creatine Muscle Mass/Weight

    Time frame: 24 weeks

    measure of total body percent muscle mass by D3-creatine dilution method

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2019
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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