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

Gastrointestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945083
• Other study ID #: BL55
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: December 9, 2021

Study information

• Verified date: January 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Tolerance
• Malnutrition

Intervention

Other:
• Experimental Nutritional Pudding
High Calorie, High Protein pudding

Locations

Country	Name	City	State
United Kingdom	North Coast Medical Ltd, Newquay Health Centre	Newquay	Cornwall
United Kingdom	Morrab Surgery	Penzance	Cornwall
United Kingdom	The Alverton Practice, Atlantic Medical	Penzance	Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	For BMI Calculation	Baseline to Study Day 28
Other	Height	For BMI Calculation	Baseline to Study Day 28
Other	Medication Usage	Subject reported medication usage	Baseline to Study Day 28
Other	Adverse Events	Subject reported adverse events	Baseline to Study Day 28
Primary	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	Study Day 1 to Study Day 8
Secondary	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	Study Day 1 to Study Day 8
Secondary	Nutritional Supplement Compliance	Subject completed daily intake questionnaire including amount of serving consumed	Study Day 1 to Study Day 28