Tolerance and Acceptability Evaluation of STOCKHOLM

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability Evaluation of STOCKHOLM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844373
• Other study ID #: AY:APL:OPD
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• STOCKHOLM
STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.

Locations

Country	Name	City	State
United Kingdom	Gemma Fry	Haywards Heath

Sponsors (1)

Lead Sponsor	Collaborator
Aymes International Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI Tolerance	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.	9 Days
Secondary	Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire	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.	9 days
Secondary	Compliance with Prescription of STOCKHOLM	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.	9 days