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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Experimental Nutritional Pudding

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • North Coast Medical Ltd, Newquay Health Centre
    • Penzance, Cornwall, United Kingdom, TR18 4EL
      • Morrab Surgery
    • Penzance, Cornwall, United Kingdom, TR18 3DX
      • The Alverton Practice, Atlantic Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Nutritional Pudding; 2 servings per day	Other: Experimental Nutritional Pudding; High Calorie, High Protein pudding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Nutritional Supplement Compliance	Subject completed daily intake questionnaire including amount of serving consumed	Study Day 1 to Study Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	For BMI Calculation	Baseline to Study Day 28
Height	For BMI Calculation	Baseline to Study Day 28
Medication Usage	Subject reported medication usage	Baseline to Study Day 28
Adverse Events	Subject reported adverse events	Baseline to Study Day 28

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ACTUAL): December 9, 2021
• Study Completion (ACTUAL): December 9, 2021

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No