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

NCT ID: NCT04259437

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2021-05-11

Brief 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.

Conditions

Gastro-Intestinal Tolerance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Protein, Energy Dense Nutritional Supplement

2 servings per day

Group Type: EXPERIMENTAL

High Protein, Energy Dense Nutritional Supplement

Intervention Type: OTHER

Ready to drink oral supplement

Interventions

High Protein, Energy Dense Nutritional Supplement

Ready to drink oral supplement

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Camprubi Robles, PhD

Role: STUDY_CHAIR

Abbott

Locations

North Coast Medical Ltd, Newquay Health Centre

Newquay, Cornwall, United Kingdom

Morrab Surgery

Penzance, Cornwall, United Kingdom

The Adam Practice

Poole, , United Kingdom

Countries

United Kingdom

Other Identifiers

BL44

Identifier Type: -

Identifier Source: org_study_id