Oral nutritional supplement for 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 will try an oral nutritional supplement in adults who are malnourished or at risk to see if they tolerate it well.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abbott Nutrition (industry)
• Locations: 3 sites (Newquay, Cornwall and 2 other locations)
• Trial ID: NCT07426406 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective, non-randomized, non-blinded, single-arm study gives an oral nutritional supplement to adults who are malnourished or at risk of malnutrition. Participants are enrolled by dietitians or clinicians and must have normal gastrointestinal function and be willing to use the supplement for at least seven days. Investigators will collect data on gastrointestinal tolerance, adherence, and any adverse events during the treatment period without a comparator group. The study is conducted at several UK clinical sites and uses objective screening tools and clinician judgment to confirm malnutrition risk.

Who should consider this trial

Good fit: Adults aged 18 or older who are judged by a dietitian or clinician to be malnourished or at risk, have normal GI function, and can take the supplement for at least seven days are ideal candidates.

Not a fit: Patients with abnormal gastrointestinal function, those who do not require oral nutritional supplements, pregnant or breastfeeding women, or individuals unable to comply with the protocol are unlikely to benefit.

Why it matters

Potential benefit: If tolerated, the supplement could help improve oral intake and support recovery for adults who are malnourished or at risk.

How similar studies have performed: Oral nutritional supplements are commonly used and prior studies have often shown improved intake and weight stabilization, although results vary by formulation and patient group.

Eligibility criteria

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.

Where this trial is running

Newquay, Cornwall and 2 other locations

• North Coast Medical — Newquay, Cornwall, United Kingdom (RECRUITING)
• Atlantic Medical Group — Penzance, Cornwall, United Kingdom (RECRUITING)
• Hull University Teaching Hospital — Anlaby, Hull, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Kristen DeLuca

Conditions: Gastrointestinal Tolerance