Energy Dense Formula to People Living in Old Peoples Home

NCT ID: NCT01259999

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

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.

Detailed Description

Malnutrition has been reported to be present in up to 55% of acutely hospitalised elderly and in one third of people living in assisted accommodation. Frail elderly with poor appetite are at risk for malnutrition. Rebecca Stratton et al have reviewed effects of oral nutritional supplements (ONS) in elderly hospital patients and key findings in hospital trials were that ONS can improve intakes of energy, protein and micronutrients without substantially reducing food intake which may lead to weight gain or attenuate weight loss.

Calogen extra is a fat emulsion containing 400 kcal/100 ml, based on canola and sunflower-oil which has a good fat composition. Moreover it contains around 30 % of recommended micronutrients and 5g protein/100 ml. It has potentially positive effects on energy intake, fatty acid profile and constipation.

The investigators have recently performed a clinical trial in geriatric patients in an acute-ward setting to evaluate the effects of a similar fat emulsion, Calogen, without micronutrients. The investigators could conclude that this fat emulsion based on MUFA and PUFA distributed three times daily at medication rounds may have positive effects on weight, appetite and serum lipids. Moreover the approach was well accepted by patients and nurses. The intervention period was very short (median 8 days) therefore the investigators plan to perform a study with a similar design, for a longer period of time, in a group of elderly living in old peoples home.

Conditions

Protein-Energy Malnutrition; Anorexia; Weight Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Energy dense formula

Group Type: EXPERIMENTAL

Calogen extra strawberry

Intervention Type: 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.

Interventions

Calogen extra strawberry

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Nutricia PDS:1005912

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karolinska University Hospital Huddinge and Karolinska Institutet/NVS

Principal Investigators

Gerd Faxen Irving, RD, PHD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital Huddinge/NVS/KI

Locations

Dep of Geriatrics, Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 26810442 (View on PubMed)

Other Identifiers

Huddinge Municipality and SLL

Identifier Type: -

Identifier Source: org_study_id