Actively Recruiting
Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
Led by Abbott Nutrition · Updated on 2026-04-13
25
Participants Needed
3
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
CONDITIONS
Official Title
Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has voluntarily signed and dated an informed consent form approved by an ethics committee and provided privacy authorization before joining the study.
- Participant is male or female aged 18 years or older.
- Participant is considered malnourished or at risk for malnutrition by a dietitian or clinician based on current oral nutritional supplement use, recent identification by a validated screening tool, or weight loss within the last two months due to hospitalization or chronic illness.
- Participant currently has normal gastrointestinal function.
- Participant requires oral nutritional supplements as assessed by a dietitian or clinician and agrees to comply with the study protocol for at least 7 days.
- Female participants must be non-pregnant, non-lactating, and at least 6 weeks postpartum prior to screening. A urine pregnancy test is required unless the female is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile.
- If of childbearing potential, participant must agree to use effective birth control during the study.
You will not qualify if you...
- Participant has severe dementia or delirium, eating disorder, significant neurological or psychiatric disorder affecting ability to answer questions, alcoholism, substance abuse, or other conditions interfering with product consumption or study compliance.
- Participant has uncontrolled diabetes with HbA1c over 9% within the last six months.
- Participant has taken antibiotics within 1 week prior to the feeding period (study day 1 may be delayed until one-week washout).
- Participant has had major gastrointestinal surgery less than 3 months before enrollment.
- Participant has active malignant disease or was treated for cancer within the last 6 months, except basal or squamous cell skin carcinoma.
- Participant has allergy or intolerance to any ingredient in the study nutritional product.
- Participant has aversion to all flavors of the product.
- Participant has gastrointestinal obstruction, inflammatory bowel disease, uncontrolled reflux disease, short bowel syndrome, or other major gastrointestinal diseases causing severe symptoms, except well-controlled reflux without medication changes in the last 3 months.
- Participant is taking medications or supplements that significantly affect metabolism or gastrointestinal motility, except multivitamins, mineral supplements, optical steroids, or inhaled steroids for asthma.
- Participant is enrolled in another non-approved study.
- Participant has a clinical condition contraindicating this product as determined by a clinician following standard care.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
North Coast Medical
Newquay, Cornwall, United Kingdom, TR7 1RU
Actively Recruiting
2
Atlantic Medical Group
Penzance, Cornwall, United Kingdom, TR18 3DX
Actively Recruiting
3
Hull University Teaching Hospital
Anlaby, Hull, United Kingdom, HU3 2PA
Actively Recruiting
Research Team
K
Kristen DeLuca
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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