Oral Nutritional Supplement in Adults With or at Risk of Malnutrition

A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein, Oral Nutritional Supplement in Adults With or at Risk of Malnutrition

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Experimental Nutrition Product

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen DeLuca; Phone Number: 6145653522; Email: kristen.deluca@abbott.com

Study Locations

• United Kingdom
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • Recruiting
      • North Coast Medical
    • Penzance, Cornwall, United Kingdom, TR18 3DX
      • Recruiting
      • Atlantic Medical Group
  • Hull
    • Anlaby, Hull, United Kingdom, HU3 2PA
      • Recruiting
      • Hull University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has voluntarily signed and dated an ICF approved by an EC and provided applicable privacy authorization prior to any participation in the study.
• Participant (male or female) is ≥ 18 years of age.
• Participant is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of ONS, recently identified as malnourished or at risk of malnutrition based on a validated malnutrition screening tool, or has had weight loss within the last two months as a result of a hospitalization or a chronic illness.
• Participant currently has normal GI function.
• Participant requires ONS as assessed by a dietitian or clinician and is willing to comply with the study protocol for at least 7 days.
• Non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the screening visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• If participant is of childbearing potential, the participant must agree to use effective forms of birth control methods for the duration of the study.

Exclusion Criteria:

• Participant 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.
• Participant has a history of uncontrolled diabetes as evidenced by HbA1c of > 9% within the last six months.
• Participant is currently taking or has taken antibiotics within 1 week prior to the feeding period (SDay 1 may be delayed until such time that the participant has completed a one-week washout period).
• Participant has undergone major GI surgery less than 3 months prior to enrollment in the study.
• Participant 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.
• Participant has an allergy or intolerance to any ingredient in the study nutritional product.
• Participant has an aversion to all of the flavours of product being assessed.
• Participant 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. Exceptions include well-controlled reflux symptoms defined as no change in medication in the last 3 months.
• Participant is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility. Exceptions include multivitamins/mineral supplements, optical steroids, and inhaled steroids for asthma.
• Participation in another study that has not been approved as a concomitant study by Abbott.
• Participant has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Nutrition Product; 2 servings per day	Other: Experimental Nutrition Product; High energy, high protein oral nutritional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools	Study Day 1 - Study Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Supplement Palatability	Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too	Study Day 1 - Study Day 7
Nutritional Supplement Compliance	Subject completed daily intake questionnaire including amount of serving consumed	Study Day 1 - Study Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Subject reported adverse events	Baseline - Study Day 8
Anthropometric	BMI calculated from Height in m and Weight in kg	Baseline and Study Day 8

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Maria Camprubi, PhD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BM05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No