MalnutritionNCT03459001
Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
An observational study of Malnutrition, run by Abbott Nutrition at 9 sites in Spain.
Trial summary
This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Tube Feeding Product
- How many people
- 17 participants
- Where
- 9 sitesSpain
- Study dates
- 8 Jun 2018to 7 Feb 2019
- Phase
- Observational
- 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
Study population: Outpatients ≥ 18 years of age that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition will be recruited.
Who may be able to join
- Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥ 2.
- Under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula.
- Requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake.
- Free living in the community or is residing in a nursing home.
- Conforms to the requirements set forth on the study product label.
Who cannot join
- Currently taking or has taken antibiotics within 2 weeks prior to enrollment.
- Consuming food PO.
- Current active cancer and the study physician determines that the subject is not suitable for the study.
- History of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus.
- Renal or liver failure.
- Pregnant as demonstrated by self-report.
Show all 12Show fewer
- Severe auto immune disease (per physician's discretion) and is on immuno-modulating therapy.
- History of allergy to any of the ingredients in the study product.
- Active Human Immunodeficiency Virus (HIV).
- Known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol.
- Condition that is contraindicated to tube feeding the study product.
- Taking part in a non-approved clinical trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Residencia Plata y Castañar
Madrid, 28021
Residencia Albertia Moratalaz
Madrid, 28030
Residencia Valle de la Oliva
Madrid, 28220
Hospital Clinico de Valencia
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
Hospital La Fe 3065
Valencia, 46026
Hospital La Fe 3066
Valencia, 46026
Hospital La Fe de Valencia 3033
Valencia, 46026
Hospital La Fe de Valencia
Valencia, 46026
About this study
Official title: A Prospective, Observational Study to Evaluate the Use of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.
- Conditions
- Malnutrition
- Being tested
- Tube Feeding Product
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube Feeding ProductOther
a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Tube Fed Malnourished Outpatients | Outpatients that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition Receives: Other: Tube Feeding Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube Feed Product Compliance
Average Daily Intake and Proportion of Days Compliant
Measured: Day 1 to Day 20
Secondary outcomes (2)
Adverse Events
Non serious AE and SAE collection
Measured: Day 0 to Day 20
Body Mass Index
Weight, Height
Measured: Day 0 to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start8 Jun 2018
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Camprubi Robles, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459001
- Sponsor's protocol ID
- BL32
- Status last verified
- Apr 2019
- First submitted
- 2 Mar 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Evaluate the Use of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT03459001
- Acronym / sponsor ID
- BL32
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 8 Mar 2018 (actual)
- 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.
This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tube Fed Malnourished Outpatients | – | Other: Tube Feeding ProductOutpatients that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients ≥ 18 years of age that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition will be recruited.
Key inclusion criteria (5 listed)
- Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥ 2.
- Under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula.
- Requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake.
- Free living in the community or is residing in a nursing home.
- Conforms to the requirements set forth on the study product label.
Key exclusion criteria (12 listed)
- Currently taking or has taken antibiotics within 2 weeks prior to enrollment.
- Consuming food PO.
- Current active cancer and the study physician determines that the subject is not suitable for the study.
- History of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus.
- Renal or liver failure.
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 |
|---|---|---|
| Tube Feeding Producta high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care | Other | Tube Fed Malnourished Outpatients |
Primary outcome
Tube Feed Product Compliance
Time frame: Day 1 to Day 20
Average Daily Intake and Proportion of Days Compliant
2 secondary outcomes
Adverse Events
Time frame: Day 0 to Day 20
Body Mass Index
Time frame: Day 0 to Day 20
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 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
Maria Camprubi Robles, PhD study chair
Abbott Nutrition
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Abbott Nutrition at 9 sites in Spain.
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 12 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
Tube Feed Product Compliance (time frame: Day 1 to Day 20). 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 Apr 2019.