Nutritional InterventionNCT01042340
Energy Dense Oleic Acid Formula to Geriatric Patients
A study testing Calogen® - an energy dense oleic acid based formula in people with Nutritional Intervention, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Background and aims: Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied. Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutritional Intervention
- What is being tested?
- Calogen® - an energy dense oleic acid based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2005to Jul 2007
- 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
- Inclusion criteria were: likely to stay at the ward more than one week, >65 years old and able to give informed consent.
Who cannot join
- Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI >30) and non-consent for participation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dep of Geriatrics, Karolinska University Hospital, Huddinge
Stockholm, 141 86
About this study
Official title: Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
Background and aims:
Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.
Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.
- Conditions
- Nutritional Intervention
- Being tested
- Calogen® - an energy dense oleic acid based formula
- Keywords
- nutrition, geriatric, supplement, energy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calogen® - an energy dense oleic acid based formulaOther
Also called SHS International LTD, UK, Nutricia Nordica AB, Sweden
A daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with energy dense formula | Experimental | Patients were randomised to intervention with the energy dense formula Calogen. Receives: Other: Calogen® - an energy dense oleic acid based formula |
| Control group | No intervention | The patients that were randomised to control group were assigned to ordinary treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power.
Measured: 5 days to 3 weeks intervention
Secondary outcomes (1)
Effects on serum lipids and appetite
Measured: 5 days to 3 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutritional InterventionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Investigators
- Gerd Faxén Irving, PhD, Principal investigator, Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042340
- Sponsor's protocol ID
- Karolinska University Hospital
- Status last verified
- Dec 2009
- First submitted
- 30 Dec 2009
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Milne AC, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003288. doi: 10.1002/14651858.CD003288.pub2.
PubMed 15846655Faxen-Irving G, Cederholm T. Energy dense oleic acid rich formula to newly admitted geriatric patients--feasibility and effects on energy intake. Clin Nutr. 2011 Apr;30(2):202-8. doi: 10.1016/j.clnu.2010.08.007. Epub 2010 Sep 19.
PubMed 20855136
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
- ClinicalTrials.gov ID
- NCT01042340
- Acronym / sponsor ID
- Karolinska University Hospital
- Conditions
- Nutritional Intervention
- Keywords
- nutrition, geriatric, supplement, energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Jan 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.
Background and aims:
Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.
Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with energy dense formula | Experimental | Other: Calogen® - an energy dense oleic acid based formulaPatients were randomised to intervention with the energy dense formula Calogen. |
| Control group | No intervention | –The patients that were randomised to control group were assigned to ordinary treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were: likely to stay at the ward more than one week, >65 years old and able to give informed consent.
Key exclusion criteria (1 listed)
- Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI >30) and non-consent for participation.
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® - an energy dense oleic acid based formulaAlso: SHS International LTD, UK, Nutricia Nordica AB, SwedenA daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00. | Other | Intervention with energy dense formula |
Primary outcome
To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power.
Time frame: 5 days to 3 weeks intervention
1 secondary outcome
Effects on serum lipids and appetite
Time frame: 5 days to 3 weeks treatment
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 Apr 2015.
- Background: PubMed 15846655Milne AC, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003288. doi: 10.1002/14651858.CD003288.pub2.
- Derived from this study: PubMed 20855136Faxen-Irving G, Cederholm T. Energy dense oleic acid rich formula to newly admitted geriatric patients--feasibility and effects on energy intake. Clin Nutr. 2011 Apr;30(2):202-8. doi: 10.1016/j.clnu.2010.08.007. Epub 2010 Sep 19.
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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 Faxén Irving, PhD principal investigator
Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute
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® - an energy dense oleic acid based formula in people with Nutritional Intervention, 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 1 inclusion and 1 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 Apr 2015. 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?
To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. (time frame: 5 days to 3 weeks intervention). 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 NCT01042340, which also lists 2 linked publications.
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 Apr 2015.