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Clinical Trials/NCT04048616
NCT04048616CompletedNot Applicable

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

Tufts University1 site in 1 country141 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
141
Locations
1
Primary Endpoint
Double Leg Press Peak Power at 70%

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •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

Arms & Interventions

maltodextrin powder + KHCO3

Active Comparator

isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3

Intervention: potassium bicarbonate (KHCO3) (Dietary Supplement)

whey protein isolate + KHCO3

Active Comparator

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

Intervention: whey protein isolate (Dietary Supplement)

whey protein isolate + KHCO3

Active Comparator

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

Intervention: potassium bicarbonate (KHCO3) (Dietary Supplement)

whey protein isolate + microcrystalline cellulose

Active Comparator

1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules

Intervention: whey protein isolate (Dietary Supplement)

maltodextrin powder + microcrystalline cellulose

Placebo Comparator

isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Intervention: microcrystalline cellulose (Other)

whey protein isolate + microcrystalline cellulose

Active Comparator

1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules

Intervention: microcrystalline cellulose (Other)

maltodextrin powder + KHCO3

Active Comparator

isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3

Intervention: maltodextrin powder (Other)

maltodextrin powder + microcrystalline cellulose

Placebo Comparator

isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Intervention: maltodextrin powder (Other)

Outcomes

Primary Outcomes

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

  • Double Leg Press Peak Power at 70%(12 weeks)
  • Double Leg Press Peak Power at 40%(12 weeks)
  • Knee Extension Peak Torque(12 weeks)
  • Handgrip Strength(24 weeks)
  • Appendicular Lean Body Mass/Height Squared(24 weeks)
  • Physical Performance Battery Score(24 weeks)
  • 24 Hour Urinary Total Nitrogen Excretion(24 weeks)
  • Double Leg Press Peak Power at 40%(24 weeks)
  • Knee Extension Peak Torque(24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisa Ceglia

Associate Professor of Medicine

Tufts University

Study Sites (1)

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