Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement

Aymes International

Status: Active, not recruiting

Conditions: Disease Related Malnutrition

Treatments: Dietary Supplement: AYMES SWIFT PLANT; Dietary Supplement: AYMES SWIFT oral nutritional supplement; Dietary Supplement: AYMES SWIFT FIBRE

Study type: Interventional

Funder types: Industry

Identifiers

NCT07452523

AY-SWIFT

Details and patient eligibility

About

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

Full description

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

AYMES SWIFT

Experimental group

Description:

Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days.

Treatment:

Dietary Supplement: AYMES SWIFT FIBRE

Dietary Supplement: AYMES SWIFT oral nutritional supplement

Dietary Supplement: AYMES SWIFT PLANT