[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625044":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":41,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":20,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":20,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Aymes International Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Shot style protein supplement","EXPERIMENTAL","Patients with or at risk of DRM, who have been clinical identified as requiring additional protein will be prescribed the study product for a period of 7-28days. Study product can be taken either orally or via a feeding tube.",[13],"Dietary Supplement: Shot Style protein supplement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Shot Style protein supplement","The Study product is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":20,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"UCLH NHS Foundation Trust","RECRUITING","London","NW1 2PG","United Kingdom","UK",{"type":30,"coordinates":31},"Point",[32,33],-0.12574,51.50853,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"James Evans, Dietetics","CONTACT","0044 0203 447 9289","j.evans28@nhs.net",{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":53,"type":54},40,"ESTIMATED","INTERVENTIONAL",[57],"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",[60],"Disease Related Malnutrition","2026-02-11",{"date":63,"type":64},"2026-02-18","ACTUAL",{"date":66,"type":64},"2022-09-30",{"date":68,"type":54},"2026-04",{"name":5,"class":6},1]