Back to resultsGastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
Primary Purpose
Gastro-Intestinal Tolerance
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Protein, Energy Dense Nutritional Supplement
Sponsored by
About this trial
This is an interventional other trial for Gastro-Intestinal Tolerance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- North Coast Medical Ltd, Newquay Health Centre
- Morrab Surgery
- The Adam Practice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Protein, Energy Dense Nutritional Supplement
Arm Description
2 servings per day
Outcomes
Primary Outcome Measures
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.
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
Nutritional Supplement Intake
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04259437
Brief Title
Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Tolerance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Protein, Energy Dense Nutritional Supplement
Arm Type
Experimental
Arm Description
2 servings per day
Intervention Type
Other
Intervention Name(s)
High Protein, Energy Dense Nutritional Supplement
Intervention Description
Ready to drink oral supplement
Primary Outcome Measure Information:
Title
Gastro-Intestinal Tolerance
Description
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.
Time Frame
Day 1 to Day 7
Title
Nutritional Supplement Palatability
Description
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough
Time Frame
Day 1 to Day 7
Title
Nutritional Supplement Intake
Description
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Time Frame
Day 1 to Day 7
Title
Nutritional Supplement Palatability
Description
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
Time Frame
Day 7
Other Pre-specified Outcome Measures:
Title
Medications
Description
Subject reported medication usage
Time Frame
Baseline to Day 7
Title
Weight
Description
For BMI Calculation
Time Frame
Baseline and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Camprubi Robles, PhD
Organizational Affiliation
Abbott
Official's Role
Study Chair
Facility Information:
Facility Name
North Coast Medical Ltd, Newquay Health Centre
City
Newquay
State/Province
Cornwall
ZIP/Postal Code
TR7 1RU
Country
United Kingdom
Facility Name
Morrab Surgery
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR18 4EL
Country
United Kingdom
Facility Name
The Adam Practice
City
Poole
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
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