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OpenTrials
Completed

NCT Number: NCT03844373

Tolerance and Acceptability Evaluation of STOCKHOLM

Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemma Fry

Haywards Heath, RH16 9PL, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STOCKHOLM

Dietary Supplement

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

Primary outcomes

  1. GI Tolerance

    Time frame: 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 outcomes

  1. Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire

    Time frame: 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.

  2. Compliance with Prescription of STOCKHOLM

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2019
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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