Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition

NCT ID: NCT04945083

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2021-12-09

Brief Summary

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.

Conditions

Gastrointestinal Tolerance

Study Design

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

Study Groups

Experimental Nutritional Pudding

2 servings per day

Group Type: EXPERIMENTAL

Experimental Nutritional Pudding

Intervention Type: OTHER

High Calorie, High Protein pudding

Interventions

Experimental Nutritional Pudding

High Calorie, High Protein pudding

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject has voluntarily signed and dated an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
• Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
• Subject currently has normal GI function
• Subject requires ONS and is willing to comply with the study protocol

Exclusion Criteria

• Subject has severe dementia or delirium, 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 had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
• Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
• Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
• Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment
• Subject has an immunodeficiency disorder
• Subject has had a myocardial infarction within the last 3 months prior to enrollment
• Subject is known to be allergic or intolerant to any ingredient found in the study product
• Subject has an aversion to any of the flavours 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 gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting
• Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility
• Participation in another study that has not been approved as a concomitant study
• Subject has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care
• 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, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

North Coast Medical Ltd, Newquay Health Centre

Newquay, Cornwall, United Kingdom

The Alverton Practice, Atlantic Medical

Penzance, Cornwall, United Kingdom

Morrab Surgery

Penzance, Cornwall, United Kingdom

Countries

United Kingdom

Other Identifiers

BL55

Identifier Type: -

Identifier Source: org_study_id