Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
NCT Number: NCT04048616
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one 15-25 gm (based on body weight) protein packet three times a day with each meal
two 13.5 mmol capsules three times a day with each meal
identical placebo capsule
isocaloric placebo powder
Time frame: 24 weeks
Double leg press peak power at 70% of the 1 repetition maximum
Time frame: 12 weeks
Double leg press peak power at 70% of the 1-repetition maximum
Time frame: 24 weeks
Double leg press peak power at 40% of the 1 repetition maximum
Time frame: 12 weeks
Double leg press peak power at 40% of the 1 repetition maximum
Time frame: 24 weeks
Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Time frame: 12 weeks
Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Time frame: 24 weeks
Measure maximum handgrip strength in either hand using handheld Jamar+ dynamometer
Time frame: 24 weeks
Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared
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
Time frame: 24 weeks
Measure based on 24 hour urine total nitrogen excretion
Time frame: 24 weeks
measure of total body percent muscle mass by D3-creatine dilution method
Tufts University
Other
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