Oral Nutritional Supplement in Adults With or at Risk of Malnutrition (NCT07426406) | Clinical Trial Compass
RecruitingNot Applicable
Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
United Kingdom25 participantsStarted 2026-03-22
Plain-language summary
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
Who can participate
Age range18 Years
SexALL
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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 a…