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OpenTrials
Completed

NCT Number: NCT03013803

Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.

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Key information

Conditions

Adult Patients in Need of High-energy Oral Nutritional Supplementation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AC Health & Nutrition Ltd

Leigh-on-Sea, SS9 3AA, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female participants ≥ 18 years of age
  • Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
  • Anticipated period of nutritional support ≥ 12 days
  • Patient has the capacity and is willing to provide informed consent.

Exclusion criteria

  • Participants with mental in capabilities who are unable to give informed consent
  • Hypersensitivity to any of the active substances or excipients within the IP
  • Severely impaired gastrointestinal function or complete failure
  • More than 50% of nutrition from Parenteral Nutrition
  • Simultaneous participation in another interventional study
  • Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
  • Participants with dysphagia requiring thickened fluids
  • Participants with significant renal impairment (CKD)
  • Pregnancy

Treatment and study plan

Nutricomp Drink Plus Fibre

Dietary Supplement

Primary outcomes

  1. Occurrence of gastrointestinal tolerance parameters

    Time frame: Day 1 - day 13

Secondary outcomes

  1. Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)

    Time frame: Day 1 - day 13

  2. Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang

    Time frame: Day 1 - day 13

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Acronym: Fuchsia

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2017
Registry last updated
Aug 11, 2017

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.