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Independent effects of whey protein and alkali supplementation on muscle health in healthy older adults: factorial randomized controlled trial.

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Τίτλος: Independent effects of whey protein and alkali supplementation on muscle health in healthy older adults: factorial randomized controlled trial.
Συγγραφείς: Ceglia L; Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, United States; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States. Electronic address: lisa.ceglia@tufts.edu., Konieczynski E; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States., Danico E; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States., Trinquart L; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States., Koethe B; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States., Xiang Q; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States., Fielding RA; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States., Evans WJ; Department of Nutritional Sciences & Toxicology, University of California, Berkeley, CA, United States., Shankaran M; Department of Nutritional Sciences & Toxicology, University of California, Berkeley, CA, United States., Dawson-Hughes B; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States.
Πηγή: The American journal of clinical nutrition [Am J Clin Nutr] 2026 May; Vol. 123 (5), pp. 101257. Date of Electronic Publication: 2026 Mar 02.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Country of Publication: United States NLM ID: 0376027 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-3207 (Electronic) Linking ISSN: 00029165 NLM ISO Abbreviation: Am J Clin Nutr Subsets: MEDLINE
Imprint Name(s): Publication: 2023- : [New York, NY] : Elsevier
Original Publication: Bethesda, MD : American Society of Clinical Nutrition
Ιατρικοί όροι (MeSH): Whey Proteins*/administration & dosage , Whey Proteins*/pharmacology , Muscle, Skeletal*/drug effects , Muscle, Skeletal*/physiology , Bicarbonates*/administration & dosage , Bicarbonates*/pharmacology , Potassium Compounds*/administration & dosage , Potassium Compounds*/pharmacology , Dietary Supplements*, Muscle Strength/drug effects ; Insulin-Like Growth Factor I/metabolism ; Humans ; Aged ; Female ; Male ; Double-Blind Method ; Aged, 80 and over
Περίληψη: Background: Aging is accompanied by reduced muscle protein synthesis and increased circulating acid, both of which contribute to declines in muscle health.
Objectives: To determine the effects of whey protein (WP) and alkali (potassium bicarbonate, KHCO3) supplementation on muscle performance and mass in healthy older adults.
Methods: In this randomized, 2 × 2 factorial, placebo-controlled study, healthy adults aged ≥65 years were assigned to either WP (1.5 g/kg/d) plus KHCO3 (81 mmol/d), WP plus placebo-KHCO3, placebo-WP plus KHCO3, or double placebo. Double leg press muscle power (primary outcome), physical performance, lean mass by dual energy x-ray absorptiometry, muscle mass by D3-creatine dilution, and serum insulin-like growth factor 1 (IGF-1) were measured at baseline and 24 weeks. Primary analyses estimated main effects of WP compared with placebo-WP and KHCO3 compared with placebo-KHCO3 using factorial comparisons "at-the-margins," following CONSORT/SPIRIT recommendations for factorial trials. Between-group differences in the 24-wk outcomes were estimated using analysis of covariance adjusted for baseline value, age, and sex.
Results: In the intention-to-treat sample (n = 128), 47.7% were female, mean ± SD age was 74 ± 6 y, and baseline protein intake was 0.85 ± 0.30 g/kg/d. Neither WP nor KHCO3 affected muscle power compared with their respective placebo {WP to placebo-WP difference 4.7 watts [95% confidence interval (CI): -21.1,30.5; P = 0.72]; KHCO3 to placebo-KHCO3 difference -13.6 watts [95% CI: -39.6, 12.4; P = 0.30]}. No group differences were noted in physical performance or muscle mass. However, 24-wk mean IGF-1 level was higher in the WP and KHCO3 groups compared with their respective placebo [WP to placebo-WP difference 14.2 ng/mL (95% CI: 7.5, 21.0; P < 0.01); KHCO3 to placebo-KHCO3 difference 7.2 ng/mL (95% CI: 0.4, 13.9; P = 0.04)].
Conclusions: In healthy free-living older adults reporting a protein intake at the current recommended daily allowance, neither increasing protein to 1.5 g/kg/d with WP nor adding a KHCO3 supplement for 24 wk improved measures of muscle power, physical performance, or muscle mass despite achieving higher circulating IGF-1 levels.
Clinical Trial Registry Number: This trial was registered as NCT04048616 at https://clinicaltrials.gov/study/NCT04048616?term=ceglia&rank=1.
(Copyright © 2026 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)
Competing Interests: Conflict of interest LC, EK, ER, LT, BK, QY, WJE, MS, and BD-H report no conflicts of interest. RAF reports grant support from Lonza, Biophytis, Amazentis, Inside Tracker, Rejuventate Biomed, Aging in Motion, scientific advisory for Biophytis, and consultancies for Embion, Biophytis, Amazentis, Pfizer, Nestle, Rejuvenate Biomed, Elevai, Merck, and Epirium Bio. MS reports consulting and advisory from MyoCorps, Inc.
Grant Information: R01 AG055443 United States AG NIA NIH HHS
Contributed Indexing: Keywords: alkali; lean mass; muscle mass; muscle strength; older adults; potassium bicarbonate; skeletal muscle; whey protein
Molecular Sequence: ClinicalTrials.gov NCT04048616
Substance Nomenclature: 0 (Whey Proteins)
HM5Z15LEBN (potassium bicarbonate)
0 (Bicarbonates)
0 (Potassium Compounds)
67763-96-6 (Insulin-Like Growth Factor I)
Entry Date(s): Date Created: 20260304 Date Completed: 20260710 Latest Revision: 20260810
Update Code: 20260811
PubMed Central ID: PMC13104605
DOI: 10.1016/j.ajcnut.2026.101257
PMID: 41780731
Βάση Δεδομένων: MEDLINE
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  Data: Independent effects of whey protein and alkali supplementation on muscle health in healthy older adults: factorial randomized controlled trial.
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  Data: &lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Ceglia+L%22&quot;&gt;Ceglia L&lt;/searchLink&gt;; Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, United States; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States. Electronic address: lisa.ceglia@tufts.edu.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Konieczynski+E%22&quot;&gt;Konieczynski E&lt;/searchLink&gt;; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Danico+E%22&quot;&gt;Danico E&lt;/searchLink&gt;; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Trinquart+L%22&quot;&gt;Trinquart L&lt;/searchLink&gt;; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Koethe+B%22&quot;&gt;Koethe B&lt;/searchLink&gt;; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Xiang+Q%22&quot;&gt;Xiang Q&lt;/searchLink&gt;; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Fielding+RA%22&quot;&gt;Fielding RA&lt;/searchLink&gt;; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Evans+WJ%22&quot;&gt;Evans WJ&lt;/searchLink&gt;; Department of Nutritional Sciences &amp; Toxicology, University of California, Berkeley, CA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Shankaran+M%22&quot;&gt;Shankaran M&lt;/searchLink&gt;; Department of Nutritional Sciences &amp; Toxicology, University of California, Berkeley, CA, United States.&lt;br /&gt;&lt;searchLink fieldCode=&quot;AU&quot; term=&quot;%22Dawson-Hughes+B%22&quot;&gt;Dawson-Hughes B&lt;/searchLink&gt;; Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, United States.
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  Data: &lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Whey+Proteins%22&quot;&gt;Whey Proteins*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Whey+Proteins+administration+%26+dosage%22&quot;&gt;administration &amp; dosage&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Whey+Proteins%22&quot;&gt;Whey Proteins*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Whey+Proteins+pharmacology%22&quot;&gt;pharmacology&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Muscle%2C+Skeletal%22&quot;&gt;Muscle, Skeletal*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Muscle%2C+Skeletal+drug+effects%22&quot;&gt;drug effects&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Muscle%2C+Skeletal%22&quot;&gt;Muscle, Skeletal*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Muscle%2C+Skeletal+physiology%22&quot;&gt;physiology&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Bicarbonates%22&quot;&gt;Bicarbonates*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Bicarbonates+administration+%26+dosage%22&quot;&gt;administration &amp; dosage&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Bicarbonates%22&quot;&gt;Bicarbonates*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Bicarbonates+pharmacology%22&quot;&gt;pharmacology&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Potassium+Compounds%22&quot;&gt;Potassium Compounds*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Potassium+Compounds+administration+%26+dosage%22&quot;&gt;administration &amp; dosage&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Potassium+Compounds%22&quot;&gt;Potassium Compounds*&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Potassium+Compounds+pharmacology%22&quot;&gt;pharmacology&lt;/searchLink&gt; &lt;br /&gt;&lt;searchLink fieldCode=&quot;MM&quot; term=&quot;%22Dietary+Supplements%22&quot;&gt;Dietary Supplements*&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Muscle+Strength%22&quot;&gt;Muscle Strength&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Muscle+Strength+drug+effects%22&quot;&gt;drug effects&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Insulin-Like+Growth+Factor+I%22&quot;&gt;Insulin-Like Growth Factor I&lt;/searchLink&gt;/&lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Insulin-Like+Growth+Factor+I+metabolism%22&quot;&gt;metabolism&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Humans%22&quot;&gt;Humans&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Aged%22&quot;&gt;Aged&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Female%22&quot;&gt;Female&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Male%22&quot;&gt;Male&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Double-Blind+Method%22&quot;&gt;Double-Blind Method&lt;/searchLink&gt; ; &lt;searchLink fieldCode=&quot;MH&quot; term=&quot;%22Aged%2C+80+and+over%22&quot;&gt;Aged, 80 and over&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: Aging is accompanied by reduced muscle protein synthesis and increased circulating acid, both of which contribute to declines in muscle health.&lt;br /&gt;Objectives: To determine the effects of whey protein (WP) and alkali (potassium bicarbonate, KHCO&lt;subscript&gt;3&lt;/subscript&gt;) supplementation on muscle performance and mass in healthy older adults.&lt;br /&gt;Methods: In this randomized, 2 &#215; 2 factorial, placebo-controlled study, healthy adults aged ≥65 years were assigned to either WP (1.5 g/kg/d) plus KHCO&lt;subscript&gt;3&lt;/subscript&gt; (81 mmol/d), WP plus placebo-KHCO&lt;subscript&gt;3&lt;/subscript&gt;, placebo-WP plus KHCO&lt;subscript&gt;3&lt;/subscript&gt;, or double placebo. Double leg press muscle power (primary outcome), physical performance, lean mass by dual energy x-ray absorptiometry, muscle mass by D&lt;subscript&gt;3&lt;/subscript&gt;-creatine dilution, and serum insulin-like growth factor 1 (IGF-1) were measured at baseline and 24 weeks. Primary analyses estimated main effects of WP compared with placebo-WP and KHCO&lt;subscript&gt;3&lt;/subscript&gt; compared with placebo-KHCO&lt;subscript&gt;3&lt;/subscript&gt; using factorial comparisons &quot;at-the-margins,&quot; following CONSORT/SPIRIT recommendations for factorial trials. Between-group differences in the 24-wk outcomes were estimated using analysis of covariance adjusted for baseline value, age, and sex.&lt;br /&gt;Results: In the intention-to-treat sample (n = 128), 47.7% were female, mean &#177; SD age was 74 &#177; 6 y, and baseline protein intake was 0.85 &#177; 0.30 g/kg/d. Neither WP nor KHCO&lt;subscript&gt;3&lt;/subscript&gt; affected muscle power compared with their respective placebo {WP to placebo-WP difference 4.7 watts [95% confidence interval (CI): -21.1,30.5; P = 0.72]; KHCO&lt;subscript&gt;3&lt;/subscript&gt; to placebo-KHCO&lt;subscript&gt;3&lt;/subscript&gt; difference -13.6 watts [95% CI: -39.6, 12.4; P = 0.30]}. No group differences were noted in physical performance or muscle mass. However, 24-wk mean IGF-1 level was higher in the WP and KHCO&lt;subscript&gt;3&lt;/subscript&gt; groups compared with their respective placebo [WP to placebo-WP difference 14.2 ng/mL (95% CI: 7.5, 21.0; P &amp;lt; 0.01); KHCO&lt;subscript&gt;3&lt;/subscript&gt; to placebo-KHCO&lt;subscript&gt;3&lt;/subscript&gt; difference 7.2 ng/mL (95% CI: 0.4, 13.9; P = 0.04)].&lt;br /&gt;Conclusions: In healthy free-living older adults reporting a protein intake at the current recommended daily allowance, neither increasing protein to 1.5 g/kg/d with WP nor adding a KHCO&lt;subscript&gt;3&lt;/subscript&gt; supplement for 24 wk improved measures of muscle power, physical performance, or muscle mass despite achieving higher circulating IGF-1 levels.&lt;br /&gt;Clinical Trial Registry Number: This trial was registered as NCT04048616 at https://clinicaltrials.gov/study/NCT04048616?term=ceglia&amp;rank=1.&lt;br /&gt; (Copyright &#169; 2026 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)
– Name: Abstract
  Label: Competing Interests
  Group: Ab
  Data: Conflict of interest LC, EK, ER, LT, BK, QY, WJE, MS, and BD-H report no conflicts of interest. RAF reports grant support from Lonza, Biophytis, Amazentis, Inside Tracker, Rejuventate Biomed, Aging in Motion, scientific advisory for Biophytis, and consultancies for Embion, Biophytis, Amazentis, Pfizer, Nestle, Rejuvenate Biomed, Elevai, Merck, and Epirium Bio. MS reports consulting and advisory from MyoCorps, Inc.
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  Data: R01 AG055443 United States AG NIA NIH HHS
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  Data: &lt;i&gt;Keywords: &lt;/i&gt;alkali; lean mass; muscle mass; muscle strength; older adults; potassium bicarbonate; skeletal muscle; whey protein
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  Data: ClinicalTrials.gov NCT04048616
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  Data: 0 (Whey Proteins)&lt;br /&gt;HM5Z15LEBN (potassium bicarbonate)&lt;br /&gt;0 (Bicarbonates)&lt;br /&gt;0 (Potassium Compounds)&lt;br /&gt;67763-96-6 (Insulin-Like Growth Factor I)
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        Text: English
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        StartPage: 101257
    Subjects:
      – SubjectFull: Muscle Strength drug effects
        Type: general
      – SubjectFull: Insulin-Like Growth Factor I metabolism
        Type: general
      – SubjectFull: Humans
        Type: general
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      – SubjectFull: Whey Proteins administration & dosage
        Type: general
      – SubjectFull: Whey Proteins pharmacology
        Type: general
      – SubjectFull: Muscle, Skeletal drug effects
        Type: general
      – SubjectFull: Muscle, Skeletal physiology
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