MalnutritionNCT02938234
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
A study testing High caloric, high protein ONS in people with Malnutrition, run by Fresenius Kabi at 1 site in Germany.
Trial summary
The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- High caloric, high protein ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Oct 2016
- 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
- Sex: male/female
- Age: 65 years or older
- Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
- Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
- Written informed consent
Who cannot join
- Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
- Subjects with galactosaemia or similar metabolic disorders
- Subjects with severely impaired gastrointestinal function or complete failure
- Subjects with insulin-requiring diabetes
- Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
- Subjects reporting frequent occurrence of migraine attacks
Show all 23Show fewer
- Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
- Existing mouth abnormalities, which cause impaired gustatory sense
- Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
- Subjects passing through chemotherapy (last cycle < 2 months ago)
- Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
- Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
- Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
- Subjects with need of a special diet contradicting the intake of the ONS
- History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- Subjects with dysphagia or with high aspiration risk
- Enrolment in another clinical study
- Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject
- Subjects who are not able to self-report GI-problems and compliance
- Subjects who report a general dislike of the ONS flavour
- Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned
- Subjects suspected or known not to follow instructions
- Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH, Clinical Pharmacology Unit
Erfurt, Thuringia, 99084
About this study
Official title: Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people
- Conditions
- Malnutrition
- Being tested
- High caloric, high protein ONS
- Keywords
- Malnutrition, Geriatric subjects, Nursing home
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High caloric, high protein ONSDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Experimental | High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration Receives: Dietary Supplement: High caloric, high protein ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Measured: At screening examination (study days -3 to -1)
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Measured: At end of study (study day 8)
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Measured: At study days 1-8
Secondary outcomes (8)
Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)
Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general
Measured: At study day 1 and at study day 7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
Measured: At study days 1-7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
Measured: At study days 1-7
Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
Measured: At study days 1-7
Use of ONS assessed by consumption time
Measured: At study days 1-7
Use of ONS assessed by servings
Confirmation of intake
Measured: At study days 1-7
Use of ONS assessed by presentation
Confirmation of serving temperature
Measured: At study days 1-7
Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)
Measured: At study days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 2016
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelius Koch, MD, Principal investigator, SocraTec R&D GmbH, Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938234
- Sponsor's protocol ID
- F3kc-001-CNI
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
- ClinicalTrials.gov ID
- NCT02938234
- Acronym / sponsor ID
- F3kc-001-CNI
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Geriatric subjects, Nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Oct 2016 (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.
The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Experimental | Dietary Supplement: High caloric, high protein ONSHigh caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Sex: male/female
- Age: 65 years or older
- Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
- Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
- Written informed consent
Key exclusion criteria (23 listed)
- Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
- Subjects with galactosaemia or similar metabolic disorders
- Subjects with severely impaired gastrointestinal function or complete failure
- Subjects with insulin-requiring diabetes
- Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
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 |
|---|---|---|
| High caloric, high protein ONS | Dietary supplement | Single-arm study |
Primary outcome
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
Time frame: At screening examination (study days -3 to -1)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
Time frame: At end of study (study day 8)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
Time frame: At study days 1-8
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
8 secondary outcomes
Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)
Time frame: At study day 1 and at study day 7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
Time frame: At study days 1-7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
Time frame: At study days 1-7
Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
Time frame: At study days 1-7
Use of ONS assessed by consumption time
Time frame: At study days 1-7
Use of ONS assessed by servings
Time frame: At study days 1-7
Use of ONS assessed by presentation
Time frame: At study days 1-7
Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)
Time frame: At study days 1-7
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 19 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Cornelius Koch, MD principal investigator
SocraTec R&D GmbH, Clinical Pharmacology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High caloric, high protein ONS in people with Malnutrition, run by Fresenius Kabi at 1 site in Germany.
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 5 inclusion and 23 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 19 Oct 2016. 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 Germany. 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?
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) (time frame: At screening examination (study days -3 to -1)). 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 19 Oct 2016.