NCT02402608

Brief Summary

This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass, strength, physical functional, quality of life, and decrease the risk of malnutrition and inflammation in sarcopenic elderly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 22, 2015

Last Update Submit

March 25, 2015

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • muscle mass assessed by dual x-ray absorptiometry

    muscle mass assessed by dual x-ray absorptiometry

    3 months

Secondary Outcomes (7)

  • muscle strength assessed by handgrip dynamometer

    3 months

  • quality of life assessed by SF-36

    3 months

  • inflammation assessed by C-reactive protein

    3 months

  • malnutrition assessed by Mini Nutritional Assessment

    3 months

  • functionality assessed by activity daily living

    3 months

  • +2 more secondary outcomes

Study Arms (2)

dietary supplement

ACTIVE COMPARATOR

oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g)

Dietary Supplement: dietary supplement

placebo

PLACEBO COMPARATOR

placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

Dietary Supplement: placebo

Interventions

dietary supplementDIETARY_SUPPLEMENT

oral essential amino acid (EAA), whey protein and vitamin D mixture

dietary supplement
placeboDIETARY_SUPPLEMENT

placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

placebo

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Eligible patients were aged 65 years or older with appendicular skeletal muscle mass/height2 2SD below mean of young adults (Baumgartner R, 1998), so with relative muscle mass \< 7.26 kg/m2 for men and \< 5.5 kg/m2 for women.
  • Patients were not affected by acute illness, severe liver, heart or kidney dysfunction, and had a body weight which had been stable for 6 months

You may not qualify if:

  • Subjects with altered glycometabolic control, disthyroidism and other endocrinopathies and cancers, as well as patients treated with steroids and heparin, or with total walking incapacity were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia

Pavia, Pavia, 27100, Italy

Location

Related Publications (3)

  • Rondanelli M, Faliva M, Monteferrario F, Peroni G, Repaci E, Allieri F, Perna S. Novel insights on nutrient management of sarcopenia in elderly. Biomed Res Int. 2015;2015:524948. doi: 10.1155/2015/524948. Epub 2015 Jan 29.

    PMID: 25705670BACKGROUND

  • Bjorkman MP, Suominen MH, Pitkala KH, Finne-Soveri HU, Tilvis RS. Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial. Trials. 2013 Nov 14;14:387. doi: 10.1186/1745-6215-14-387.

    PMID: 24225081BACKGROUND

  • Rondanelli M, Klersy C, Terracol G, Talluri J, Maugeri R, Guido D, Faliva MA, Solerte BS, Fioravanti M, Lukaski H, Perna S. Whey protein, amino acids, and vitamin D supplementation with physical activity increases fat-free mass and strength, functionality, and quality of life and decreases inflammation in sarcopenic elderly. Am J Clin Nutr. 2016 Mar;103(3):830-40. doi: 10.3945/ajcn.115.113357. Epub 2016 Feb 10.

    PMID: 26864356DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • mariangela rondanelli, MD, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2015

First Posted

March 30, 2015

Study Start

January 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

IT(1)