Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

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

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.

Study Overview

• Status: Completed
• Conditions: Gastro-Intestinal Tolerance
• Intervention / Treatment: Other: High Protein, Energy Dense Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Poole, United Kingdom
    • The Adam Practice
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • North Coast Medical Ltd, Newquay Health Centre
    • Penzance, Cornwall, United Kingdom, TR18 4EL
      • Morrab Surgery

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 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.

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: High Protein, Energy Dense Nutritional Supplement; 2 servings per day	Other: High Protein, Energy Dense Nutritional Supplement; Ready to drink oral supplement

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.	Day 1 to Day 7
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	Day 1 to Day 7
Nutritional Supplement Intake	Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed	Day 1 to Day 7
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	Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medications	Subject reported medication usage	Baseline to Day 7
Weight	For BMI Calculation	Baseline and Day 7

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2020
• Primary Completion (ACTUAL): May 11, 2021
• Study Completion (ACTUAL): May 11, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL44

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