Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial

Jürgen M. Bauer (Lead / Corresponding author), Sjors Verlaan, Ivan Bautmans, Kirsten Brandt, Lorenzo M. Donini, Marcello Maggio, Marion E. T. McMurdo, Tony Mets, Chris Seal, Sander L. Wijers, Gian Paolo Ceda, Giuseppe De Vito, Gilbert Donders, Michael Drey, Carolyn Greig, Ulf Holmbäck, Marco Narici, Jamie McPhee, Eleonora Poggiogalle, Dermot PowerAldo Scafoglieri, Ralf Schultz, Cornel C. Sieber, Tommy Cederholm

    Research output: Contribution to journalArticle

    214 Citations (Scopus)
    118 Downloads (Pure)

    Abstract

    BACKGROUND: Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.

    OBJECTIVE: To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.

    DESIGN: A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.

    RESULTS: Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.

    CONCLUSIONS: This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.

    Original languageEnglish
    Pages (from-to)740-747
    Number of pages8
    JournalJournal of the American Medical Directors Association
    Volume16
    Issue number9
    Early online date10 Jul 2015
    DOIs
    Publication statusPublished - 1 Sep 2015

    Fingerprint

    Sarcopenia
    Vitamin D
    Leucine
    Placebos
    Muscles
    Control Groups
    Independent Living
    Muscle Strength
    Geriatrics
    Lower Extremity
    Skeletal Muscle
    Quality of Life
    Confidence Intervals
    Exercise
    Whey Proteins

    Keywords

    • Lower extremity function
    • Muscle mass
    • Nutritional supplementation
    • Protein
    • Sarcopenia

    Cite this

    Bauer, Jürgen M. ; Verlaan, Sjors ; Bautmans, Ivan ; Brandt, Kirsten ; Donini, Lorenzo M. ; Maggio, Marcello ; McMurdo, Marion E. T. ; Mets, Tony ; Seal, Chris ; Wijers, Sander L. ; Ceda, Gian Paolo ; De Vito, Giuseppe ; Donders, Gilbert ; Drey, Michael ; Greig, Carolyn ; Holmbäck, Ulf ; Narici, Marco ; McPhee, Jamie ; Poggiogalle, Eleonora ; Power, Dermot ; Scafoglieri, Aldo ; Schultz, Ralf ; Sieber, Cornel C. ; Cederholm, Tommy. / Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study : a randomized, double-blind, placebo-controlled trial. In: Journal of the American Medical Directors Association. 2015 ; Vol. 16, No. 9. pp. 740-747.
    @article{2b185f2cac9145509db3ad18e36256c4,
    title = "Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial",
    abstract = "BACKGROUND: Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.OBJECTIVE: To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.DESIGN: A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.RESULTS: Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95{\%} confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.CONCLUSIONS: This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.",
    keywords = "Lower extremity function, Muscle mass, Nutritional supplementation, Protein, Sarcopenia",
    author = "Bauer, {J{\"u}rgen M.} and Sjors Verlaan and Ivan Bautmans and Kirsten Brandt and Donini, {Lorenzo M.} and Marcello Maggio and McMurdo, {Marion E. T.} and Tony Mets and Chris Seal and Wijers, {Sander L.} and Ceda, {Gian Paolo} and {De Vito}, Giuseppe and Gilbert Donders and Michael Drey and Carolyn Greig and Ulf Holmb{\"a}ck and Marco Narici and Jamie McPhee and Eleonora Poggiogalle and Dermot Power and Aldo Scafoglieri and Ralf Schultz and Sieber, {Cornel C.} and Tommy Cederholm",
    note = "Copyright {\circledC} 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.",
    year = "2015",
    month = "9",
    day = "1",
    doi = "10.1016/j.jamda.2015.05.021",
    language = "English",
    volume = "16",
    pages = "740--747",
    journal = "Journal of the American Medical Directors Association",
    issn = "1525-8610",
    publisher = "Elsevier",
    number = "9",

    }

    Bauer, JM, Verlaan, S, Bautmans, I, Brandt, K, Donini, LM, Maggio, M, McMurdo, MET, Mets, T, Seal, C, Wijers, SL, Ceda, GP, De Vito, G, Donders, G, Drey, M, Greig, C, Holmbäck, U, Narici, M, McPhee, J, Poggiogalle, E, Power, D, Scafoglieri, A, Schultz, R, Sieber, CC & Cederholm, T 2015, 'Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial', Journal of the American Medical Directors Association, vol. 16, no. 9, pp. 740-747. https://doi.org/10.1016/j.jamda.2015.05.021

    Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study : a randomized, double-blind, placebo-controlled trial. / Bauer, Jürgen M. (Lead / Corresponding author); Verlaan, Sjors; Bautmans, Ivan; Brandt, Kirsten; Donini, Lorenzo M.; Maggio, Marcello; McMurdo, Marion E. T.; Mets, Tony; Seal, Chris; Wijers, Sander L.; Ceda, Gian Paolo; De Vito, Giuseppe; Donders, Gilbert; Drey, Michael; Greig, Carolyn; Holmbäck, Ulf; Narici, Marco; McPhee, Jamie; Poggiogalle, Eleonora; Power, Dermot; Scafoglieri, Aldo; Schultz, Ralf; Sieber, Cornel C.; Cederholm, Tommy.

    In: Journal of the American Medical Directors Association, Vol. 16, No. 9, 01.09.2015, p. 740-747.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of Sarcopenia in older adults, the PROVIDE study

    T2 - a randomized, double-blind, placebo-controlled trial

    AU - Bauer, Jürgen M.

    AU - Verlaan, Sjors

    AU - Bautmans, Ivan

    AU - Brandt, Kirsten

    AU - Donini, Lorenzo M.

    AU - Maggio, Marcello

    AU - McMurdo, Marion E. T.

    AU - Mets, Tony

    AU - Seal, Chris

    AU - Wijers, Sander L.

    AU - Ceda, Gian Paolo

    AU - De Vito, Giuseppe

    AU - Donders, Gilbert

    AU - Drey, Michael

    AU - Greig, Carolyn

    AU - Holmbäck, Ulf

    AU - Narici, Marco

    AU - McPhee, Jamie

    AU - Poggiogalle, Eleonora

    AU - Power, Dermot

    AU - Scafoglieri, Aldo

    AU - Schultz, Ralf

    AU - Sieber, Cornel C.

    AU - Cederholm, Tommy

    N1 - Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

    PY - 2015/9/1

    Y1 - 2015/9/1

    N2 - BACKGROUND: Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.OBJECTIVE: To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.DESIGN: A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.RESULTS: Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.CONCLUSIONS: This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.

    AB - BACKGROUND: Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.OBJECTIVE: To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.DESIGN: A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.RESULTS: Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.CONCLUSIONS: This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.

    KW - Lower extremity function

    KW - Muscle mass

    KW - Nutritional supplementation

    KW - Protein

    KW - Sarcopenia

    UR - http://www.scopus.com/record/display.url?eid=2-s2.0-84940452443&origin=resultslist&sort=plf-f&src=s&st1=Effects+of+a+Vitamin+D+and+Leucine-Enriched+Whey+Protein+Nutritional+Supplement+on+Measures+of+Sarcopenia+in+Older+Adults%2c+the+PROVIDE+Study%3a+A+Randomized%2c+Double-Blind%2c+Placebo-Controlled+Trial&st2=&sid=BD24DD7530E87151AF25F5A7417E5B3E.zQKnzAySRvJOZYcdfIziQ%3a1020&sot=b&sdt=b&sl=209&s=TITLE-ABS-KEY%28Effects+of+a+Vitamin+D+and+Leucine-Enriched+Whey+Protein+Nutritional+Supplement+on+Measures+of+Sarcopenia+in+Older+Adults%2c+the+PROVIDE+Study%3a+A+Randomized%2c+Double-Blind%2c+Placebo-Controlled+Trial%29&relpos=0&relpos=0&citeCnt=1&searchTerm=TITLE-ABS-KEY%28Effects+of+a+Vitamin+D+and+Leucine-Enriched+Whey+Protein+Nutritional+Supplement+on+Measures+of+Sarcopenia+in+Older+Adults%2C+the+PROVIDE+Study%3A+A+Randomized%2C+Double-Blind%2C+Placebo-Controlled+Trial%29

    U2 - 10.1016/j.jamda.2015.05.021

    DO - 10.1016/j.jamda.2015.05.021

    M3 - Article

    C2 - 26170041

    VL - 16

    SP - 740

    EP - 747

    JO - Journal of the American Medical Directors Association

    JF - Journal of the American Medical Directors Association

    SN - 1525-8610

    IS - 9

    ER -