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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutritional intervention among geriatric patients residing at home, randomized controlled trial (RCT)
Scientific title
Nutritional intervention compared to normal care among geriatric patients during six months period in protein intake and quality of life
Secondary ID [1] 285905 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatric patients recovering from acute illness and discharged from hospital to home 293822 0
Malnutrition 293823 0
Condition category
Condition code
Diet and Nutrition 294125 294125 0 0
Other diet and nutrition disorders

Study type
Description of intervention(s) / exposure
Participants in this study are people over 65 years of age and who are recovering from an acute illness after hospitalization. Intervention includes six months tailored nutritional guidance and individual home sessions administered by a dietitian. First one-hour visit takes place after discharge from rehabilitation center and then the dietitian evaluates the need for further one hour guidance sessions, max. 3 sessions. Guidance is based on food diaries, the results of the baseline measurements, home visits, and discussions with the participants and their possible caregivers. Oral nutritional supplement are advised to use and given to participants when food and protein intakes are low. The intervention will be a process which responds and continues step by step according to participants’ individual needs. Adherence is monitored by the consumption of dietary supplements and checking protein intake at 3 months point in the intervention.
Intervention code [1] 290881 0
Intervention code [2] 290882 0
Treatment: Other
Comparator / control treatment
Persons in the control group will receive written nutritional information after randomization and at the end of the trial handbooks about good nutrition and good sources of protein for the aged people.
Control group

Primary outcome [1] 293927 0
Protein intake is assessed by 3 day food diaries and analysed Fineli (
Timepoint [1] 293927 0
6 months
Primary outcome [2] 293928 0
Quality of life with 15D
Timepoint [2] 293928 0
6 months
Secondary outcome [1] 312158 0
Nutritional status with MNA
Timepoint [1] 312158 0
6 months
Secondary outcome [2] 312159 0
Grip strength using a handgrip dynamometer
Timepoint [2] 312159 0
6 months
Secondary outcome [3] 312160 0
Muscle strength with 5 times chair rise and 5 meters walk
Timepoint [3] 312160 0
6 months
Secondary outcome [4] 312161 0
Balance test used Romberg's test
Timepoint [4] 312161 0
6 months
Secondary outcome [5] 312162 0
Body composition by DEXA scan
Timepoint [5] 312162 0
6 months
Secondary outcome [6] 312163 0
Cognition with MMSE
Timepoint [6] 312163 0
6 months
Secondary outcome [7] 312164 0
Use of health and social services by data linkage to patient medical and social records
Timepoint [7] 312164 0
12 months
Secondary outcome [8] 312165 0
Timepoint [8] 312165 0
24 months
Secondary outcome [9] 313056 0
Cost effectiveness of nutritional care by the use of health and social services by data linkage to patient medical and social records
Timepoint [9] 313056 0
12 months

Key inclusion criteria
age > 65 years, recovering from acute illness, able to return home from rehabilitation
Minimum age
65 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Disease probably leading to death in less than six months, dementia

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6575 0
State/province [1] 6575 0

Funding & Sponsors
Funding source category [1] 290486 0
Government body
Name [1] 290486 0
Finlands Slot Machine Association
Address [1] 290486 0
RAY, PL 35, 00521 Helsinki
Country [1] 290486 0
Primary sponsor type
Commercial sector/Industry
Nutricia Medical in Finland
Nutricia Medical Oy
Linnankatu 26 A
20100 TURKU
Secondary sponsor category [1] 289187 0
Name [1] 289187 0
Society for Gerontological Nutrition in Finland
Address [1] 289187 0
Toinen linja 3, 00530 Helsinki
Country [1] 289187 0

Ethics approval
Ethics application status

Brief summary
The aim of this study is to 1) assess nutritional status, protein and nutrient intake and functional capacity, 2) investigate the effectiveness of tailored nutritional care with randomised, controlled design, 3) assess the cost effectiveness of nutritional care and 4) implement nutritional care as a part of rehabilitation and cope at home of older patients who are recovering from acute illnesses.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 53758 0
A/Prof Merja Suominen
Address 53758 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53758 0
Phone 53758 0
Fax 53758 0
Email 53758 0
Contact person for public queries
Name 53759 0
A/Prof Merja SUominen
Address 53759 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53759 0
Phone 53759 0
Fax 53759 0
Email 53759 0
Contact person for scientific queries
Name 53760 0
A/Prof Merja Suominen
Address 53760 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53760 0
Phone 53760 0
Fax 53760 0
Email 53760 0

No information has been provided regarding IPD availability
Summary results
No Results