Gastro-Intestinal ToleranceNCT04259437
Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
A study testing High Protein, Energy Dense Nutritional Supplement in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-Intestinal Tolerance
- What is being tested?
- High Protein, Energy Dense Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 10 Mar 2020to 11 May 2021
- 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
- Subject has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
- Subject is considered malnourished or at risk for malnutrition
- Subject has normal GI function
- Subject requires oral nutritional supplementation ands is willing to comply with the study protocol
Who cannot join
- Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Subject has a history of diabetes
- Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
- Subject has undergone major GI surgery less than 3 months prior to enrollment
- Subject has active malignant disease or was treated within the last 6 months for cancer
- Subject has immunodeficiency disorder
Show all 14Show fewer
- Subject has had a myocardial infarction within the last 3 months prior to enrollment
- Subject is known to be allergic to intolerant to an ingredient found in the study product
- Subject has an aversion to the flavor of product being tested
- Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting
- Subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility.
- Participation in another study that has not yet been approved as a concomitant study by the Sponsor.
- Subject has a clinical condition that is contraindicated with this product.
- Subject is pregnant.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
North Coast Medical Ltd, Newquay Health Centre
Newquay, Cornwall, TR7 1RU
Morrab Surgery
Penzance, Cornwall, TR18 4EL
The Adam Practice
Poole
About this study
Official title: A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein Low Volume Oral Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.
- Conditions
- Gastro-Intestinal Tolerance
- Being tested
- High Protein, Energy Dense Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein, Energy Dense Nutritional SupplementOther
Ready to drink oral supplement
| Study group | Role | What they receive |
|---|---|---|
| High Protein, Energy Dense Nutritional Supplement | Experimental | 2 servings per day Receives: Other: High Protein, Energy Dense Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-Intestinal Tolerance
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.
Measured: Day 1 to Day 7
Nutritional Supplement Palatability
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough
Measured: Day 1 to Day 7
Nutritional Supplement Intake
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Measured: Day 1 to Day 7
Nutritional Supplement Palatability
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough for additional flavors
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Mar 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal ToleranceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259437
- Sponsor's protocol ID
- BL44
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein Low Volume Oral Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT04259437
- Acronym / sponsor ID
- BL44
- Conditions
- Gastro-Intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 6 Feb 2020 (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.
The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Protein, Energy Dense Nutritional Supplement | Experimental | Other: High Protein, Energy Dense Nutritional Supplement2 servings per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
- Subject is considered malnourished or at risk for malnutrition
- Subject has normal GI function
- Subject requires oral nutritional supplementation ands is willing to comply with the study protocol
Key exclusion criteria (14 listed)
- Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Subject has a history of diabetes
- Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
- Subject has undergone major GI surgery less than 3 months prior to enrollment
- Subject has active malignant disease or was treated within the last 6 months for cancer
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 Protein, Energy Dense Nutritional SupplementReady to drink oral supplement | Other | High Protein, Energy Dense Nutritional Supplement |
Primary outcome
Gastro-Intestinal Tolerance
Time frame: Day 1 to Day 7
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.
Nutritional Supplement Palatability
Time frame: Day 1 to Day 7
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough
Nutritional Supplement Intake
Time frame: Day 1 to Day 7
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Nutritional Supplement Palatability
Time frame: Day 7
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough for additional flavors
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 11 Jun 2021.
- 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.
Maria Camprubi Robles, PhD study chair
Abbott
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein, Energy Dense Nutritional Supplement in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 3 sites in United Kingdom.
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 14 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 Tolerance (time frame: Day 1 to Day 7). The study lists 4 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 11 Jun 2021.