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

Gastro-Intestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259437
• Other study ID #: BL44
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: May 11, 2021

Study information

• Verified date: June 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastro-Intestinal Tolerance
• Malnutrition

Intervention

Other:
• High Protein, Energy Dense Nutritional Supplement
Ready to drink oral supplement

Locations

Country	Name	City	State
United Kingdom	North Coast Medical Ltd, Newquay Health Centre	Newquay	Cornwall
United Kingdom	Morrab Surgery	Penzance	Cornwall
United Kingdom	The Adam Practice	Poole

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medications	Subject reported medication usage	Baseline to Day 7
Other	Weight	For BMI Calculation	Baseline and Day 7
Primary	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
Primary	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
Primary	Nutritional Supplement Intake	Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed	Day 1 to Day 7
Primary	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