[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disease-related-malnutrition\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disease-related-malnutrition":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100625044","tolerance-and-acceptability-evaluation-of-an-oral-nutrition-supplement-100625044",false,"NCT07417514","Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement","Tolerance and Acceptability Evaluation of AYMES Protein Shot","Inclusion Criteria:\n\n* Adult patients (≥18 years) who are able to communicate clearly.\n* Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)\n* Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and\u002For by professional clinical judgement.\n* Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study\n* Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)\n* No feeding tube for any patient taking the neutral variant.\n* Patients with significant hepatic impairment.\n* Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.\n* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.\n* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.\n* Any participant unable to give consent i.e., those with dementia.\n* Participants under 18 years of age.\n* Individuals who do not have sufficient proficiency with English language\n* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube",[26],"Disease Related Malnutrition","RECRUITING","2026-02-11",{"date":30,"type":31},"2026-02-18","ACTUAL",{"date":33,"type":31},"2022-09-30",{"date":35,"type":20},"2026-04",{"name":37,"class":38},"Aymes International Limited","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100576155","effect-of-plant-based-high-energy-high-protein-oral-nutritional-supplement-on-nutritional-intake-in-patients-with-or-at-risk-of-disease-related-malnutrition-100576155","NCT06781619","Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.","PRO-PLANT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Identified as at medium or high risk of malnutrition based on:\n\n   1. MUST score ≥ 1 and \u002F or\n   2. Being prescribed with ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study\n3. In need of 2 servings of ONS\u002Fday (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional.\n4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.\n5. Willing to maintain dietary habits for the duration of the study.\n6. Willing to consume plant based as well as dairy based ONS\n\nExclusion Criteria:\n\n1. Known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the appendix of this protocol).\n2. Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance who use lactase may still be enrolled in the study.\n3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.\n4. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) \\>6 (Crohn's disease) or Simple Clinical Colitis Activity Index (SCCAI) \\>5 (ulcerative colitis).\n5. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate \\\u003C30 mL\u002Fmin\u002F1.73 m2).\n6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.\n7. Subjects following a vegan diet.",{"count":48,"type":20},80,[23],"The subjects will use study product twice daily for 8 weeks starting at Visit 1. The recommendation is to consume one serving in the morning and one in the afternoon \u002F evening between meals. The duration of the study for each subject will be approximately 11 weeks, comprising a screening period of max 2 weeks, an intervention period of 8 weeks, and a follow up phone call 1 week after completion of the intervention. A blood sample will be drawn at visit 1 and visit 3.",[26],"2025-09-23",{"date":54,"type":31},"2025-09-24",{"date":56,"type":31},"2025-03-17",{"date":58,"type":20},"2027-07",{"name":60,"class":38},"Nutricia Research","Disease-related Malnutrition"]