Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001253897
Ethics application status
Approved
Date submitted
21/11/2012
Date registered
28/11/2012
Date last updated
28/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Porvoo Sarcopenia & Nutrition Trial
Scientific title
In older people with sarcopenia, does protein supplementation, compared to isocaloric placebo or no supplementation, maintain or improve physical performance
Secondary ID [1] 281572 0
Nil
Universal Trial Number (UTN)
U1111-1136-9080
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age related muscle loss i.e. sarcopenia 287855 0
Condition category
Condition code
Musculoskeletal 288213 288213 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. standard treatment and no supplementation for 12 months

Arm 2. standard treatment and milk protein supplementation of 20 grams (50% whey) twice a day for 12 months. The protein supplementation will be given in a form of 250 ml x 2 strawberry flavoured beverage and it contains 70 kcal/100ml of energy.

Arm 3. standard treatment and isocaloric placebo supplementation twice a day for 12 months. The isocaloric placebo supplementation will be given in a form of 250 ml x 2 strawberry flavoured beverage and it contains 1 g/100ml milk proteins (20% whey) and 70 kcal/100ml of energy.

Standard treatment will include: a) instructions to perform twice a day 10-30 min home based unsupervised simple exercises (chair rise, steps, etc.), b) instructions to eat proteins on every meal from different protein sources of regular foods, and c) instructions to use vitamin D3 supplementation with a dose of 20 ug/d. The compliance to all treatments is up to the participants themselves and the compliance is followed by daily written patient diaries that are collected every three months.
Intervention code [1] 286096 0
Treatment: Other
Intervention code [2] 286116 0
Lifestyle
Comparator / control treatment
Standard treatment and isocaloric placebo supplement
Control group
Placebo

Outcomes
Primary outcome [1] 288406 0
Changes in physical performance according to short physical performance battery (Guralnik et al. 1994) and continuous summary physical performance scores (Nieves et al. 2005).
Timepoint [1] 288406 0
At 6 and 12 months after randomisation
Primary outcome [2] 288407 0
Changes in muscle health according to hand grip strength (Bohannan 2008), habitual 4-meter gait speed (Guralnik et al. 1994, Nieves et al. 2005), balance (Guralnik et al. 1994, Nieves et al. 2005), chair stand test power (Takai et al. 2009), and 2-minute step test (Rikli & Jones 1999).
Timepoint [2] 288407 0
At 6 and 12 months after randomisation
Secondary outcome [1] 300067 0
Compliance to supplementation and home based exercises according to patient diaries.
Timepoint [1] 300067 0
At 6 and 12 months after randomisation
Secondary outcome [2] 300068 0
Patient reported benefits and adverse effects according to patient interview. The expected adverse effects are different gastrointestinal symptoms. No severe adverse effects are expected.
Timepoint [2] 300068 0
At 6 and 12 months after randomisation
Secondary outcome [3] 300069 0
Changes in nutrition according to Mini Nutritional Assessment (Guigoz et al. 2002), diet quality questionnaire (Makela & Laitinen 2012), and dietary records (Suominen et al. 2007)
Timepoint [3] 300069 0
At 6 and 12 months after randomisation
Secondary outcome [4] 300070 0
Changes in body composition according to body mass index and direct segmental bioimpedance spectroscopy measurements (Yamada et al. 2010, Bjorkman et al. 2012).
Timepoint [4] 300070 0
At 6 and 12 months after randomisation
Secondary outcome [5] 300071 0
Changes in cognition according to Mini Mental State Examination (Folstein et al. 1975), verbal fluency (Welsh et al. 1991) and clock drawing test (Sunderland et al. 1989), and clinical dementia rating sum of boxes (Hughes et al. 1982).
Timepoint [5] 300071 0
At 6 and 12 months after randomisation
Secondary outcome [6] 300072 0
Changes in health related quality of life according to SF/RAND-36 (Hays et al. 1993) and 15D (Sintonen 2001) patient questionnaires.
Timepoint [6] 300072 0
At 6 and 12 months after randomisation
Secondary outcome [7] 300073 0
Use of health care (number of hospitalization/follow-up time) and social services (number of institutionalization/follow-up time) according to patient records
Timepoint [7] 300073 0
At 12 and 24 months after randomisation
Secondary outcome [8] 300074 0
Number of falls according to simple patient questionnaires and medical record data.
Timepoint [8] 300074 0
At 6 and 12 months after randomisation
Secondary outcome [9] 300075 0
Mortality according National Census records
Timepoint [9] 300075 0
At 12 and 24 months after randomisation
Secondary outcome [10] 300076 0
Serum and plasma markers of inflammation, anabolism, glycemic control and renal function. Blood samples are deep frozen for later analyses and details on methods are a matter of availability of funds.
Timepoint [10] 300076 0
At 6 and 12 months after randomisation

Eligibility
Key inclusion criteria
75 years or older, living permanently at home in Porvoo, Finland

low hand grip strength (men < 30.0 kg, women < 20.0 kg) or slow habitual gait speed (< 0,80 m/s)

low skeletal muscle index (2 standard deviations below young adults) measured by direct segmental calf bioimpedance spectroscopy.

voluntary participation, written informed consent to participate in study by participant or her/his closest proxy.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not living at home

not able to walk indoors independently (canes and walkers allowed)

not able to co-operate with hand grip, walking speed, and bioimpedance measurements

plasma creatinine > 150 µmol/l

terminal illness (estimated prognosis > 6 months)

cardiac pacemaker

bilateral replacement arthroplasty of the knee

severe skin lesions in bioimpedance electrode placement sites (dorsal foot, dorsal ankle, lateral knee, dorsal wrist, and dorsal palm)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients will be randomized into three arms by computer generated random numbers. The content of the supplement (protein vs. isocaloric placebo) will be randomized off-site by staff not belonging to the research group and kept sealed until the analysis of 12-month endpoints.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of 100 sets of numbers 1, 2, and 3 in random order are computer-generated to indicate each treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 4689 0
Finland
State/province [1] 4689 0

Funding & Sponsors
Funding source category [1] 286366 0
University
Name [1] 286366 0
University of Helsinki
Country [1] 286366 0
Finland
Funding source category [2] 286367 0
Charities/Societies/Foundations
Name [2] 286367 0
Yrjo Jahnsson Foundation
Country [2] 286367 0
Finland
Funding source category [3] 286368 0
Charities/Societies/Foundations
Name [3] 286368 0
Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
Country [3] 286368 0
Sweden
Primary sponsor type
University
Name
University of Helsinki
Address
Tukholmankatu 8 B, 7.krs
POB 20
Biomedicum Helsinki
00014 University of Helsinki
Country
Finland
Secondary sponsor category [1] 285147 0
Government body
Name [1] 285147 0
Municipal social and health services of Porvoo, Finland
Address [1] 285147 0
Raatihuoneenkatu 5 B
06100 Porvoo
Country [1] 285147 0
Finland
Other collaborator category [1] 277194 0
Government body
Name [1] 277194 0
National Institute for Health and Welfare
Address [1] 277194 0
P.O. Box 30
FI-00271 Helsinki
Country [1] 277194 0
Finland
Other collaborator category [2] 277195 0
Charities/Societies/Foundations
Name [2] 277195 0
Society for Memory Disorders Expertise in Finland
Address [2] 277195 0
Fredriksberginkatu 2
00240 Helsinki
Country [2] 277195 0
Finland
Other collaborator category [3] 277196 0
Commercial sector/Industry
Name [3] 277196 0
Valio Ltd.
Address [3] 277196 0
P.O. BOX 10
00039 VALIO
Country [3] 277196 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288442 0
Ethics committee for internal medicine of hospital district of helsinki and uusimaa
Ethics committee address [1] 288442 0
Ethics committee country [1] 288442 0
Finland
Date submitted for ethics approval [1] 288442 0
Approval date [1] 288442 0
11/01/2012
Ethics approval number [1] 288442 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34973 0
Address 34973 0
Country 34973 0
Phone 34973 0
Fax 34973 0
Email 34973 0
Contact person for public queries
Name 18220 0
Mikko Bjorkman
Address 18220 0
Askolinintie 1
06100 Porvoo
Country 18220 0
Finland
Phone 18220 0
+358504273040
Fax 18220 0
Email 18220 0
[email protected]
Contact person for scientific queries
Name 9148 0
Mikko Bjorkman
Address 9148 0
Askolinintie 1
06100 Porvoo
Country 9148 0
Finland
Phone 9148 0
+358504273040
Fax 9148 0
Email 9148 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBioimpedance analysis and physical functioning as mortality indicators among older sarcopenic people.2019https://dx.doi.org/10.1016/j.exger.2019.04.012
EmbaseSarcopenia Indicators as Predictors of Functional Decline and Need for Care among Older People.2019https://dx.doi.org/10.1007/s12603-019-1280-0
N.B. These documents automatically identified may not have been verified by the study sponsor.