Energy Dense Formula to People Living in Old Peoples Home

NCT01259999 | Completed

• 1 other identifier: Huddinge Municipality and SLL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary intake in frail elderly is often lower than estimated needs due to the combined effects of the anorexia of ageing, frailty and the presence of acute and chronic disease. The objectives of the present study are to assess the effects of an oleic acid rich formula fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength and mobility. The investigators have recently performed a similar study in an acute ward setting without micronutrients.

Conditions

Protein-Energy Malnutrition; Anorexia; Weight Change

Keywords

malnutrition; oleic-acid; micronutrient supplement; old peoples home

Outcome Measures

Primary Outcomes (1)

• Increased intake of energy and nutrients

  The sample size has been estimated upon a minimum difference in daily energy intake between the Control and Calogen group of 200 kcal (4). To detect a significant difference in energy intake at the 5% significance level and with 80% power 27 subjects in each group were needed. To allow for study drop-outs this is increased to 30 subjects in each group.

  6 weeks as intervention 6 weeks as control

Secondary Outcomes (1)

• Increased appetite

  6 weeks intervention 6 weeks control

Study Arms (1)

Energy dense formula

EXPERIMENTAL

Dietary Supplement: Calogen extra strawberry

Interventions

Calogen extra strawberry DIETARY_SUPPLEMENT

A daily dose of 3 x 30 ml Calogen extra strawberry flavour will be distributed at the same time as the medicines i.e. at 8.00, 12.00 and 20.00.

Also known as: Nutricia PDS:1005912

Energy dense formula

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>65 years old
• Mini nutritional assessment-short form (MNA-SF)score \< 12 points
• able to give informed consent.

You may not qualify if:

• pancreatitis
• fat malabsorption, non-consent for participation.
• Subjects that have Calogen will be excluded.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Dep of Geriatrics, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• Tylner S, Cederholm T, Faxen-Irving G. Effects on Weight, Blood Lipids, Serum Fatty Acid Profile and Coagulation by an Energy-Dense Formula to Older Care Residents: A Randomized Controlled Crossover Trial. J Am Med Dir Assoc. 2016 Mar 1;17(3):275.e5-11. doi: 10.1016/j.jamda.2015.12.005. Epub 2016 Jan 23.

  PMID: 26810442 DERIVED

MeSH Terms

Conditions

Protein-Energy Malnutrition; Anorexia; Body Weight Changes; Malnutrition

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight

Study Officials

• Gerd Faxen Irving, RD, PHD

  Karolinska University Hospital Huddinge/NVS/KI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2011-06

Locations

SE (1)