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

NCT04945083 | Completed

• 1 other identifier: BL55
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

  Study Day 1 to Study Day 8

Secondary Outcomes (2)

• Nutritional Supplement Palatability

  Study Day 1 to Study Day 8

• Nutritional Supplement Compliance

  Study Day 1 to Study Day 28

Other Outcomes (4)

• Weight

  Baseline to Study Day 28

• Height

  Baseline to Study Day 28

• Medication Usage

  Baseline to Study Day 28

Study Arms (1)

Experimental Nutritional Pudding

EXPERIMENTAL

2 servings per day

Other: Experimental Nutritional Pudding

Interventions

Experimental Nutritional Pudding OTHER

High Calorie, High Protein pudding

Experimental Nutritional Pudding

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (3)

North Coast Medical Ltd, Newquay Health Centre

Newquay, Cornwall, TR7 1RU, United Kingdom

Location

The Alverton Practice, Atlantic Medical

Penzance, Cornwall, TR18 3DX, United Kingdom

Location

Morrab Surgery

Penzance, Cornwall, TR18 4EL, United Kingdom

Location

Study Officials

• Maria Camprubi, PhD

  Abbott Nutrition

  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: June 7, 2021
• First Posted: June 30, 2021
• Study Start: January 13, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)