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Completed

NCT Number: NCT01433211

Nutrition and Frailty in Older Persons

The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Biomedicine of Aging, University of Erlangen-Nürnberg

Nuremberg, 90419, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

Relation Between Nutrition and Frailty in Community-dwelling Older Persons

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 13, 2011
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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