Protein-Energy MalnutritionNCT01259999
Energy Dense Formula to People Living in Old Peoples Home
A study testing Calogen extra strawberry in people with Protein-Energy Malnutrition and Anorexia, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Protein-Energy Malnutrition, Anorexia, Weight Change
- What is being tested?
- Calogen extra strawberry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- Mini nutritional assessment-short form (MNA-SF)score < 12 points
- able to give informed consent.
Who cannot join
- pancreatitis
- fat malabsorption, non-consent for participation.
- Subjects that have Calogen will be excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dep of Geriatrics, Karolinska University Hospital
Stockholm, 141 86
About this study
Official title: Distribution of an Energy Rich Formula at Medication Rounds to Individuals Living in Old Peoples Home - Effects on Energy Intake Compared to Standard Nutritional Treatment
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.
Read the 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
- Being tested
- Calogen extra strawberry
- Keywords
- malnutrition, oleic-acid, micronutrient supplement, old peoples home
- Medical subject headings
- Protein-Energy Malnutrition, Anorexia, Body Weight Changes, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calogen extra strawberryDietary supplement
Also called Nutricia PDS:1005912
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.
| Study group | Role | What they receive |
|---|---|---|
| Energy dense formula | Experimental | Not described Receives: Dietary Supplement: Calogen extra strawberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks as intervention 6 weeks as control
Secondary outcomes (1)
Increased appetite
Measured: 6 weeks intervention 6 weeks control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein-Energy MalnutritionStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Investigators
- Gerd Faxen Irving, RD, PHD, Principal investigator, Karolinska University Hospital Huddinge/NVS/KI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259999
- Sponsor's protocol ID
- Huddinge Municipality and SLL
- Status last verified
- Jun 2011
- First submitted
- 14 Dec 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26810442
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of an Energy Rich Formula at Medication Rounds to Individuals Living in Old Peoples Home - Effects on Energy Intake Compared to Standard Nutritional Treatment
- ClinicalTrials.gov ID
- NCT01259999
- Acronym / sponsor ID
- Huddinge Municipality and SLL
- Conditions
- Protein-Energy Malnutrition, Anorexia, Weight Change
- Keywords
- malnutrition, oleic-acid, micronutrient supplement, old peoples home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy dense formula | Experimental | Dietary Supplement: Calogen extra strawberry |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >65 years old
- Mini nutritional assessment-short form (MNA-SF)score < 12 points
- able to give informed consent.
Key exclusion criteria (3 listed)
- pancreatitis
- fat malabsorption, non-consent for participation.
- Subjects that have Calogen will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calogen extra strawberryAlso: Nutricia PDS:1005912A 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. | Dietary supplement | Energy dense formula |
Primary outcome
Increased intake of energy and nutrients
Time frame: 6 weeks as intervention 6 weeks as control
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.
1 secondary outcome
Increased appetite
Time frame: 6 weeks intervention 6 weeks control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 26810442Tylner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Faxen Irving, RD, PHD principal investigator
Karolinska University Hospital Huddinge/NVS/KI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calogen extra strawberry in people with Protein-Energy Malnutrition and Anorexia, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased intake of energy and nutrients (time frame: 6 weeks as intervention 6 weeks as control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.