Gastrointestinal ToleranceNCT04945083

Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition

A study testing Experimental Nutritional Pudding in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Tolerance
What is being tested?: Experimental Nutritional Pudding
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 3 sitesUnited Kingdom
Study dates: 13 Jan 2021to 9 Dec 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 an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
Subject currently has normal GI function
Subject requires ONS and is willing to comply with the study protocol

Who cannot join

Subject has severe dementia or delirium, 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 had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment
Subject has an 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 or intolerant to any ingredient found in the study product
Subject has an aversion to any of the flavours 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 gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting
Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility
Participation in another study that has not been approved as a concomitant study
Subject has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care
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
The Alverton Practice, Atlantic Medical
Penzance, Cornwall, TR18 3DX
Morrab Surgery
Penzance, Cornwall, TR18 4EL

Other trials in United Kingdom

About this study

Official title: Gastrointestinal Tolerance and Acceptability of a High Protein, High Calorie Pudding in Adult Patients With/or at Risk for Malnutrition

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.

Conditions: Gastrointestinal Tolerance
Being tested: Experimental Nutritional Pudding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Nutritional PuddingOther
High Calorie, High Protein pudding

Study groups in NCT04945083
Study group	Role	What they receive
Experimental Nutritional Pudding	Experimental	2 servings per day Receives: Other: Experimental Nutritional Pudding

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: Study Day 1 to Study Day 8

Secondary outcomes (2)

Nutritional Supplement Palatability
Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too
Measured: Study Day 1 to Study Day 8
Nutritional Supplement Compliance
Subject completed daily intake questionnaire including amount of serving consumed
Measured: Study Day 1 to Study Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 20219 Dec 2021

First posted30 Jun 2021
Study start13 Jan 2021
Primary completion9 Dec 2021
Study completion9 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastrointestinal 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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04945083
Sponsor's protocol ID: BL55
Status last verified: Jan 2022
First submitted: 7 Jun 2021
Last updated: 13 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular Carcinoma
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 1/2
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
Liver Failure
Active, not recruiting
Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Healthy Pregnant Women
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance

All Gastrointestinal Tolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gastrointestinal Tolerance and Acceptability of a High Protein, High Calorie Pudding in Adult Patients With/or at Risk for Malnutrition
ClinicalTrials.gov ID: NCT04945083
Acronym / sponsor ID: BL55
Conditions: Gastrointestinal Tolerance
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Abbott NutritionIndustry (pharma, biotech, devices)
Study start: 13 Jan 2021 (actual)
Primary completion: 9 Dec 2021 (actual)
Study completion: 9 Dec 2021 (actual)
First posted: 30 Jun 2021 (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 is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Nutritional Pudding	Experimental	Other: Experimental Nutritional Pudding2 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 an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
Subject currently has normal GI function
Subject requires ONS and is willing to comply with the study protocol

Key exclusion criteria (14 listed)

Subject has severe dementia or delirium, 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 had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment

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
Experimental Nutritional PuddingHigh Calorie, High Protein pudding	Other	Experimental Nutritional Pudding

Primary outcome

Gastro-Intestinal Tolerance
Time frame: Study Day 1 to Study Day 8
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools

2 secondary outcomes

Nutritional Supplement Palatability
Time frame: Study Day 1 to Study Day 8
Nutritional Supplement Compliance
Time frame: Study Day 1 to Study Day 28

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 2022.
Individual participant dataSharing planned: No

Related trials for Gastrointestinal Tolerance

RecruitingPhase 1
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular Carcinoma
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 1/2
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
Liver Failure
Active, not recruiting
Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Healthy Pregnant Women
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance

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, PhD study chair

Abbott Nutrition

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Nutritional Pudding in people with Gastrointestinal 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 13 Jan 2022. 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: Study Day 1 to Study Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945083.

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 2022.