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

NCT04259437 | Completed

• 1 other identifier: BL44
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Medications

  Baseline to Day 7

• Weight

  Baseline and Day 7

Study Arms (1)

High Protein, Energy Dense Nutritional Supplement

EXPERIMENTAL

2 servings per day

Other: High Protein, Energy Dense Nutritional Supplement

Interventions

High Protein, Energy Dense Nutritional Supplement OTHER

Ready to drink oral supplement

High Protein, Energy Dense Nutritional Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (3)

North Coast Medical Ltd, Newquay Health Centre

Newquay, Cornwall, TR7 1RU, United Kingdom

Location

Morrab Surgery

Penzance, Cornwall, TR18 4EL, United Kingdom

Location

The Adam Practice

Poole, United Kingdom

Location

Study Officials

• Maria Camprubi Robles, PhD

  Abbott

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 6, 2020
• Study Start: March 10, 2020
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)