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Completed

NCT Number: NCT04703881

Tolerance and Acceptability Evaluation AYMES ActaGain

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

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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

AYMES International Ltd.

Haywards Heath, RH16 9PL, United Kingdom

About this study

To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'AYMES ActaGain' (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

  • Male and female patients.
  • ≥ 18 years of age.
  • Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
  • Patient is able and willing to provide written informed consent.

Exclusion criteria

  • Patients with medical or dietary contraindication to any feed ingredients.
  • Patients requiring sole enteral tube feeding or parenteral nutrition.
  • Patients with chronic renal disease requiring dialysis.
  • Patients with liver failure.
  • Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
  • Patients assessed by a Speech and Language Therapist who require thickened fluids.
  • Participation in any other studies that may interfere with this study.

Treatment and study plan

AYMES ActaGain

Dietary Supplement

AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.

Primary outcomes

  1. Gastro-Intestinal Tolerance when consuming AYMES ActaGain

    Time frame: 30 days

    To assess gastro-intestinal tolerance of 'AYMES ActaGain' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.

Secondary outcomes

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

    Time frame: 30 days

    To assess the acceptability of 'AYMES ActaGain' 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. A 5 point hedonic scale will be used.

  2. Compliance

    Time frame: 30 days

    To assess the acceptability of 'AYMES ActaGain' in patients in the community requiring oral nutritional supplementation. A daily compliance diary will be kept detailing compliance to prescription versus prescribed amount.

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2021
Registry last updated
Jan 11, 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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