Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04048616
Study type Interventional
Source Tufts University
Contact
Status Completed
Phase N/A
Start date November 1, 2019
Completion date December 21, 2023

See also
  Status Clinical Trial Phase
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Enrolling by invitation NCT05215964 - The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Completed NCT01292395 - Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency N/A
Completed NCT00755638 - A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers Phase 1
Completed NCT04546048 - The Early Strength Training Program in Post-transplant Liver Cases N/A
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A
Completed NCT04422665 - Preventing Bed-rest Induced Muscle Loss in the Elderly N/A
Completed NCT05088304 - GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Completed NCT03400046 - The Correlation Between Nutrients and Muscle Mass N/A
Completed NCT01894737 - The Effect of Creatine on Muscle Loss N/A
Completed NCT01714479 - Skeletal Muscle Response to Amino Acids and Load Carriage Exercise N/A
Completed NCT05072652 - Short Term Immobilization of the Lower Limb N/A
Completed NCT04661618 - A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention. N/A
Completed NCT05009654 - The Effect of Leucine on Carnitine Transport to Skeletal Muscle N/A
Recruiting NCT05795556 - Biomarkers of Sarcopenia and Frailty in Geriatric Patients
Completed NCT04151108 - Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients