Tolerance and Acceptability Evaluation AYMES Cardiff

NCT ID: NCT04703894

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2020-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate tolerance and acceptability of 'CARDIFF' 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 'CARDIFF' (to allow for prescription in the community at NHS expense).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AYMES 'CARDIFF'

Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'CARDIFF' for a period of 30 days.

Group Type EXPERIMENTAL

AYMES 'CARDIFF'

Intervention Type DIETARY_SUPPLEMENT

AYMES CARDIFF is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AYMES 'CARDIFF'

AYMES CARDIFF is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female patients.
* ≥ 18 years of age.
* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 30 days.
* 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 significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
* Patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aymes International Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AYMES International Ltd.

Haywards Heath, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AY:CAR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Bioavailability of Mycoprotein
NCT04233411 COMPLETED NA
Gluten Sensitivity in Non-Celiac Patients
NCT01485341 COMPLETED PHASE3
GlutDigest - Pilot Study
NCT04489836 COMPLETED NA
Study of Tolerance to Oral Peanut
NCT01259804 COMPLETED PHASE1