Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement

N/AActive Not RecruitingNCT07452523

Aymes International Limited40 enrolled

Overview

To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.

To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded. To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Disease Related Malnutrition

Interventions

AYMES SWIFT oral nutritional supplementDIETARY_SUPPLEMENT

The study supplement is an oral nutritional supplement and food for special medical purposes.

AYMES SWIFT FIBREDIETARY_SUPPLEMENT

An oral nutritional supplement and food for special medical purposes.

AYMES SWIFT PLANTDIETARY_SUPPLEMENT

A plant based oral nutritional supplement and food for special medical purposes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female •≥ 18 years of age * Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools \[i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan\] * Expected to receive at least one bottle of ONS per day * Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign Exclusion Criteria: * Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding * Participants with major hepatic dysfunction (i.e., decompensated liver disease) * Participants with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\] * Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function * Participants with significant dysphagia/high aspiration risk * Participation in other clinical intervention studies within 1 month of this study * Participants lacking mental capacity to consent * Allergy to any study product ingredients (appendix 2) * Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Locations (1)

Preston Hill Surgery

Harrow, United Kingdom

Outcomes

Primary Outcomes

Acceptability and palatability of an oral nutriitonal supplement.

To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking.

Time frame: 7 days

Gastro-intestinal Tolerance

To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days. A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention. Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points.

Time frame: 7 days

Compliance

To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.

Time frame: 7 days

Data from ClinicalTrials.gov

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