MalnutritionNCT02698540
A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment
An observational study of Malnutrition, run by Abbott Nutrition at 23 sites in Spain.
Trial summary
The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional Supplement
- How many people
- 95 participants
- Where
- 23 sitesSpain
- Study dates
- 28 Nov 2016to May 2018
- 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: The study population will include men and women who are free living (outpatient) or residing in a nursing home.
Who may be able to join
- Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2.
- Subject is ≥18 years old.
- Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
- Subject conforms to the requirements set forth on the study product label.
- Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.
Who cannot join
- The study physician determines the subject is not fit to participate
- Subject cannot provide informed consent to participate in the study.
- Subject cannot safely consume the oral nutritional supplement.
- Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit.
- Type 1 or type 2 diabetes.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
Hospital de Cruces 1758
Barakaldo, 48903
Hospital de Cruces 2029
Barakaldo, 48903
Hospital de Jerez
Cadiz, 11407
Hospital Universitario Reina Sofía de Córdoba
Córdoba, 14004
Hospital Universitario Campus de la Salud
Granada, 18016
Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion
León, 24080
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Principe de Asturias
Madrid, 28805
Hospital Universitario de Móstoles
Madrid, 28935
Centro Médico San Juan de la Cruz
Málaga, 29007
Hospital Costa del Sol 1740
Marbella, 29603
Hospital Costa del Sol 1743
Marbella, 29603
Hospital Rey Juan Carlos
Móstoles, 28933
Hospital General Universitario Reina Sofía de Murcia
Murcia, 30003
Hospital Vega Baja
Orihuela, 03314
Hospital del Bierzo
Ponferrada, 24404
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clínico Universitario de Valencia 1695
Valencia, 46010
Hospital La Ribera
Valencia, 46600
Hospital de Vic
Vic, 08500
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment
The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.
- Conditions
- Malnutrition
- Being tested
- Nutritional Supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementOther
High calorie, high protein peptide based
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Product Compliance
Subject reported diaries
Measured: Baseline to Week 12
Secondary outcomes (5)
Body Weight
Measured: Baseline to Week 12
Nutrition Status
Healthcare Professional completed screening
Measured: Baseline to Week 12
Quality of Life
Subject reported questionnaire
Measured: Baseline to Week 12
Gastrointestinal Tolerance
Subject reported scale
Measured: Baseline to Week 12
Body Mass Index
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start28 Nov 2016
- Primary completionMay 2018
- Study completionMay 2018
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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Sanz Barriuso, RD, PharmD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698540
- Sponsor's protocol ID
- DA13
- Status last verified
- Aug 2018
- First submitted
- 23 Feb 2016
- Last updated
- 27 Aug 2018
- 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 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment
- ClinicalTrials.gov ID
- NCT02698540
- Acronym / sponsor ID
- DA13
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Mar 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 purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include men and women who are free living (outpatient) or residing in a nursing home.
Key inclusion criteria (5 listed)
- Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2.
- Subject is ≥18 years old.
- Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
- Subject conforms to the requirements set forth on the study product label.
- Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.
Key exclusion criteria (5 listed)
- The study physician determines the subject is not fit to participate
- Subject cannot provide informed consent to participate in the study.
- Subject cannot safely consume the oral nutritional supplement.
- Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit.
- Type 1 or type 2 diabetes.
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 |
|---|---|---|
| Nutritional SupplementHigh calorie, high protein peptide based | Other | – |
Primary outcome
Study Product Compliance
Time frame: Baseline to Week 12
Subject reported diaries
5 secondary outcomes
Body Weight
Time frame: Baseline to Week 12
Nutrition Status
Time frame: Baseline to Week 12
Quality of Life
Time frame: Baseline to Week 12
Gastrointestinal Tolerance
Time frame: Baseline to Week 12
Body Mass Index
Time frame: Baseline to Week 12
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 27 Aug 2018.
- 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.
Rebecca Sanz Barriuso, RD, PharmD study chair
Abbott Nutrition
23 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 23 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 5 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Study Product Compliance (time frame: Baseline to Week 12). 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 27 Aug 2018.