Tolerance and Acceptability Evaluation of STOCKHOLM

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: STOCKHOLM

• Registration Number: NCT03844373
• Lead Sponsor: Aymes International Limited

Brief Summary

Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.

Detailed Description

To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To obtain data to support an ACBS submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).

Study Timeline

• Study Start: 2018-11-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who are able to communicate their views regarding acceptability.
• Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day
• Patients expected to require oral nutritional supplementation for at least 2 further weeks.
• Informed consent obtained.

Exclusion Criteria

• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
• Patients requiring a milk free diet
• Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
• Patients with significant renal or hepatic impairment
• Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
• Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	STOCKHOLM	Patients established on an oral nutritional supplement, being prescribed oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of STOCKHOLM for a period of 9 days.

Primary Outcome Measures

Name	Time	Method
GI Tolerance	9 Days	To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.

Secondary Outcome Measures

Name	Time	Method
Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire	9 days	To assess the acceptability of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. At the end 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 supplement drink.
Compliance with Prescription of STOCKHOLM	9 days	Recording of amount of STOCKHOLM consumed by subjects compared to amount prescribed. Good compliance = \>80% of prescribed being consumed. Same data collected for baseline product and compared with that of STOCKHOLM.

Trial Locations

Locations (1)

Gemma Fry; 🇬🇧 Haywards Heath, United Kingdom