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Nutrition and Frailty in Older Persons

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433211
First Posted: September 13, 2011
Last Update Posted: September 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nestlé
Information provided by (Responsible Party):
dorothee volkert, University of Erlangen-Nürnberg Medical School
  Purpose
The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

Condition
Frailty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Relation Between Nutrition and Frailty in Community-dwelling Older Persons

Further study details as provided by dorothee volkert, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Frailty (according to Fried et al.) [ Time Frame: 1 day ]

    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)


Secondary Outcome Measures:
  • Impaired physical performance (according to Guralnik et al.) [ Time Frame: 1 day ]

    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.



Enrollment: 206
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community-living persons aged 75 years or older
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433211


Locations
Germany
Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
Nürnberg, Germany, 90419
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Nestlé