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Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT04259437•Abbott Nutrition

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (3)

North Coast Medical Ltd, Newquay Health Centre

Newquay, Cornwall, United Kingdom

Morrab Surgery

Penzance, Cornwall, United Kingdom

The Adam Practice

Poole, United Kingdom

Key Dates

Start Date

March 10, 2020

Primary Completion Date

May 11, 2021

Completion Date

May 11, 2021

Last Updated

June 11, 2021

Enrollment

ACTUAL participants

Conditions

Gastro-Intestinal Tolerance

Interventions

High Protein, Energy Dense Nutritional Supplement

OTHER

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WITHDRAWNNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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