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

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Experimental Nutritional Pudding

• Registration Number: NCT04945083
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Nutritional Pudding	Experimental Nutritional Pudding	2 servings per day

Primary Outcome Measures

Name	Time	Method
Gastro-Intestinal Tolerance	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

Secondary Outcome Measures

Name	Time	Method
Nutritional Supplement Palatability	Study Day 1 to Study Day 8	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
Nutritional Supplement Compliance	Study Day 1 to Study Day 28	Subject completed daily intake questionnaire including amount of serving consumed

Trial Locations

Locations (3)

The Alverton Practice, Atlantic Medical; 🇬🇧 Penzance, Cornwall, United Kingdom

North Coast Medical Ltd, Newquay Health Centre; 🇬🇧 Newquay, Cornwall, United Kingdom

Morrab Surgery; 🇬🇧 Penzance, Cornwall, United Kingdom