Nutrition and Frailty in Older Persons

This study has been completed.

Sponsor:

Collaborator:

Nestlé

Information provided by (Responsible Party):

dorothee volkert, University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT01433211

First received: September 7, 2011

Last updated: September 11, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 7, 2011
Last Updated Date	September 11, 2011
Start Date ^ICMJE	August 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 11, 2011)	Frailty (according to Fried et al.) [ Time Frame: 1 day ] [ Designated as safety issue: No ] Frailty is defined as the presence of at least 3 of the following criteria: self-reported weight loss of more than 4.5 kg in the last year exhaustion (self-reported feeling that everything was an effort or one could not get "going" > 2 times a week) low grip strength (men ≤ 29-32 kg, women ≤ 17-21 kg depending on BMI), low walking speed (> 6-7 sec/ 4.57 m, depending on gender and height) low physical activity (men < 383 kcal/ week, women < 270 kcal/ week)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01433211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 11, 2011)	Impaired physical performance (according to Guralnik et al.) [ Time Frame: 1 day ] [ Designated as safety issue: No ] Impaired physical performance is definded as less than 9 points in the Short Physical Performance Battery (SPPB). Three physical performance tests (balance, walking speed and chair-rise) are performed in a standardised manner and rated with 0-4 points each. SPPB is the sum score of these three test resuslts with a maximum of 12 points indicating the best physical performance.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nutrition and Frailty in Older Persons
Official Title ^ICMJE	Relation Between Nutrition and Frailty in Community-dwelling Older Persons
Brief Summary	The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.
Detailed Description	Nutrition is regarded as an important etiologic factor in the development of frailty in older adults. To date the relation between nutrition and frailty is only poorly described. Thus, it is the purpose of this study to investigate the association between different nutrition characteristics and frailty in older community-living persons. 206 volunteers aged 75 years or older were included in this cross-sectional study. Nutritional assessment included the Mini-Nutritional Assessment (MNA), a food-frequency questionnaire and a standardised three-day dietary record. Intake of energy and nutrients was calculated using the German nutrient database BLS II.2. Dietary patterns were described by different dietary scores. Frailty was defined according to Fried et al. based on the following criteria: weight loss, exhaustion, grip strength, walking speed and physical activity. In addition several standardised tests were performed to characterise physical performance (Timed Up & Go, repeated chair stands, balance tests). The association between nutritional aspects and physical performance is evaluated in an explorative manner.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Community-living persons aged 75 years or older
Condition ^ICMJE	Frailty
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	No treatment
Publications *	Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	206
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age of 75 years and older living independently at home Exclusion Criteria: acute illness cognitive impairment (Mini Mental State Examination ≥ 24 out of 30 points)
Gender	Both
Ages	75 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01433211
Other Study ID Numbers ^ICMJE	IBA-2011(1)
Has Data Monitoring Committee	No
Responsible Party	dorothee volkert, University of Erlangen-Nürnberg Medical School
Study Sponsor ^ICMJE	University of Erlangen-Nürnberg Medical School
Collaborators ^ICMJE	Nestlé
Investigators ^ICMJE	Not Provided
Information Provided By	University of Erlangen-Nürnberg Medical School
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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