MalnutritionNCT02029079
The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
A study testing E+ in people with Malnutrition, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished The objective of this study is to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- E+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of homecare services in the municipality of Bergen
- Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment)
- Informed consent by participant
- Informed consent by participants and close relatives or guardian in case of dementia
Who cannot join
- Terminal care patients with < 3 month life expectancy
- Patients using parenteral or enteral nutrition
- Patients prescribed oral nutritional supplementation before recruitment
- Pregnancy
- Diabetes Mellitus
- Lactose intolerance
- Patients without a norwegian personal identification number
- Psychiatric patients
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished
The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.
Read the detailed description
Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome.
Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community.
The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements.
The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.
- Conditions
- Malnutrition
- Being tested
- E+
- Keywords
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E+Dietary supplement
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
| Study group | Role | What they receive |
|---|---|---|
| E+ drink, enriched with energy and nutrients. | Experimental | The intervention consists of 300 ml E+ per day for 35 days in addition to a normal food intake. This means 525 kcal, and 22.5 gram protein extra per day for five weeks. Receives: Dietary Supplement: E+ |
| Control | No intervention | Subjects in the control group will be assessed in the same way and same time as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hand grip strength
Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial.
Measured: Assessment at day 0, 35 and 70.
Change in Body weight
Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales.
Measured: At day 0, 35 and 70
Change in Body composition
A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals.
Measured: At day 0, 35 and 70
Secondary outcomes (2)
Change in Nutritional intake
Dietary intake will be assessed for each study participant using a twenty-four-hour recall method conducted by the investigator and two additional people employed to help with the data collection. All three data collectors will use a standardized interview. The data collected will be used to calculate daily calorie and protein intake by entering the food records into a computerized version of a food composition table, Dietist XP.
Measured: At day 0, 35 and 70
Change in Quality of life
Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL).
Measured: At day 0, 35 and 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Haukeland 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randi J Tangvik, PhD-student, Study chair, Clinical Dietitian at Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029079
- Sponsor's protocol ID
- 2013/962
- Status last verified
- Jan 2014
- First submitted
- 18 Dec 2013
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT02029079
- Acronym / sponsor ID
- 2013/962
- Conditions
- Malnutrition
- Keywords
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jan 2014 (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.
Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished
The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.
Detailed description
Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome.
Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community.
The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements.
The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E+ drink, enriched with energy and nutrients. | Experimental | Dietary Supplement: E+The intervention consists of 300 ml E+ per day for 35 days in addition to a normal food intake. This means 525 kcal, and 22.5 gram protein extra per day for five weeks. |
| Control | No intervention | –Subjects in the control group will be assessed in the same way and same time as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients of homecare services in the municipality of Bergen
- Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment)
- Informed consent by participant
- Informed consent by participants and close relatives or guardian in case of dementia
Key exclusion criteria (8 listed)
- Terminal care patients with < 3 month life expectancy
- Patients using parenteral or enteral nutrition
- Patients prescribed oral nutritional supplementation before recruitment
- Pregnancy
- Diabetes Mellitus
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 |
|---|---|---|
| E+300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days. | Dietary supplement | E+ drink, enriched with energy and nutrients. |
Primary outcome
Change in Hand grip strength
Time frame: Assessment at day 0, 35 and 70.
Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial.
Change in Body weight
Time frame: At day 0, 35 and 70
Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales.
Change in Body composition
Time frame: At day 0, 35 and 70
A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals.
2 secondary outcomes
Change in Nutritional intake
Time frame: At day 0, 35 and 70
Change in Quality of life
Time frame: At day 0, 35 and 70
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 13 Jan 2014.
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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.
Randi J Tangvik, PhD-student study chair
Clinical Dietitian at Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E+ in people with Malnutrition, run by Haukeland University Hospital at 1 site in Norway.
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 4 inclusion and 8 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 13 Jan 2014. 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 Norway. 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?
Change in Hand grip strength (time frame: Assessment at day 0, 35 and 70.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2014.