Acceptability, tolerance and ease of use study of Wilbo’s Blends+

  • Research type

    Research Study

  • Full title

    A single arm intervention study to assess the acceptability, tolerance and ease of use of Wilbo’s Blends+ (a nutritionally complete commercial enteral formula made with real food ingredients) when used by parents of children and young people (3-15 years) as part of a dietitian prescribed enteral feeding plan.

  • IRAS ID

    349234

  • Contact name

    Sarah Durnan

  • Contact email

    s.durnan@nhs.net

  • Sponsor organisation

    Nottingham University Hospitals NHS Trust

  • Clinicaltrials.gov Identifier

    NCT07036081

  • Duration of Study in the UK

    0 years, 5 months, 27 days

  • Research summary

    Over 70,000 people in the UK require long-term enteral feeding, where food is given through a tube. Standard practice is for commercial enteral formula to be prescribed. However, there is an increasing trend towards giving homemade blended food through the gastrostomy tube, referred to as ‘blended diet’.
    Studies have found blended diet to be a safe and nutritious alternative, with children on blended diet having fewer gastrointestinal symptoms and improvements in health and wellbeing reported. There is also a growing desire to use unprocessed food and de-medicalise feeding.
    National and international guidance advises that blended diet should always be offered as an option. However, barriers exist meaning this is not always possible. Blended diet can be more costly and time consuming and is not always possible outside of the home, for example at school, respite, hospital or on holiday. There is a clear need for a predominantly real food, nutritionally complete, commercial product to help make blended diet accessible to all.
    Wilbo’s Blends+ is a new, unique enteral feed made of real food with fortification which meets this need. This study will evaluate Wilbo’s Blends+ to see if it is acceptable and tolerated by tube-fed children and easy to use for their parents/carers. If the results are positive, the company will apply to make Wilbo’s Blends+ available on prescription.
    This study will trial Wilbo’s Blends+ in children (age 3-15) over 7 days as part of their feeding plan and collect acceptability, tolerance and ease of use data using questionnaires from parents/carers alongside clinical teams.
    The study is sponsored by Nottingham University Hospitals NHS Trust (NUH) and the funding comes from Innovate UK; a research grant awarded to the company Wilbo’s Blends. Up to 40 children and their parents/carers will take part from NUH and Manchester University NHS Foundation Trust.

    Lay summary of study results: A study of Wilbo’s Blends Plus enteral products in children (IRAS number: 349234)

    Thank you to study participants
    We would like to thank every child and family who took part in this study. The daily records and feedback you provided made this research possible. Your contribution will help improve feeding options for other tube-fed children.

    Study title
    A study to assess the tolerance, compliance, acceptability and ease of use of Wilbo’s Blends Plus in children receiving tube feeding.

    Who carried out the research?
    The study was sponsored by Nottingham University Hospitals NHS Trust. It was led by Dr Sarah Durnan, a Registered Dietitian specialising in blended diets.

    The study was carried out in collaboration with Wilbo’s Blends Limited, the company that makes the study products. Wilbo’s Blends was set up by the parents of a child who is tube fed. The study was funded by Innovate UK.

    Where and when did the study take place?
    Children took part at two NHS sites: Nottingham University Hospitals NHS Trust and Manchester University NHS Foundation Trust. Children used the products at home as part of their normal routine. The study closed in March 2026.

    Why was the research needed?
    Some children cannot eat enough by mouth to meet their nutritional needs. They are fed through a tube directly into the stomach, called a gastrostomy.

    Most children are given ready-made liquid enteral formulas. However, some children have ongoing gut symptoms on these formulas, such as constipation, vomiting or discomfort.
    Many families prefer to give blended ‘real food’ meals through the tube instead. Home blending can help, but it also takes time and it can be hard to be sure the diet is nutritionally complete.
    Wilbo’s Blends Plus is a ready-to-use enteral product based on real food ingredients, with added vitamins and minerals. This study tested two recipes: Chicken Casserole and Vegetable Bake.

    What were the main questions studied?
    • Do children tolerate the products well, with no worsening of gut symptoms?
    • Do children manage to take the amount prescribed by their dietitian?
    • Do families find the products acceptable and easy to use?
    • What do the children’s healthcare teams think of the products?

    Who participated in the study?
    Twenty-seven children took part: 18 boys and 9 girls. They were aged 3 to 15 years, with a typical (median) age of 8 years.
    All were fed through a gastrostomy tube and had long-term medical conditions. These included neurological, genetic and neuromuscular conditions, and feeding or eating disorders.

    What did the participants receive?
    Each child was invited to try both recipes, one at a time, with at least a week’s break in between. In total, 23 children tried Chicken Casserole and 25 tried Vegetable Bake.

    The study products provided between 30% and 100% of each child’s daily energy needs, as planned by their dietitian. Each recipe was taken for 7 days in a row.

    Eleven of the 23 children on Chicken Casserole, and 9 of the 25 on Vegetable Bake, switched to the study product gradually over up to 6 days; the others swapped straight away. This depended on how used they were to real food ingredients and fibre.

    What happened during the study?
    Parents and carers kept daily records of gut symptoms, stool patterns and how much of the product was taken. At the end of each 7-day period, they completed a questionnaire about acceptability and ease of use.

    The child’s dietitian or doctor then reviewed how well each child had got on with the products.

    What were the results of the study?
    Gut symptoms
    For each symptom, at least 20 of 23 children (87%) on Chicken Casserole rated it the same as, or better than, before the study. On Vegetable Bake this was at least 22 of 25 children (88%).
    Families reported 160 gut symptoms before the study started. Of these, 136 (85%) improved during the 7 days on the products, and none got worse.

    Constipation improved the most: 14 of 23 children on Chicken Casserole and 13 of 25 on Vegetable Bake were better than before. Stool consistency stayed in the ideal range, with no overall change during the study.

    Amount taken (compliance)
    Children typically took more than 90% of the amount their dietitian prescribed. In only 5 of the 48 study periods did a child take less than 75% of the planned amount. These lower intakes were mainly due to practical reasons, such as starting records during the changeover period, rather than problems with the product.

    Acceptability and taste
    Every family who completed the questionnaire rated the appearance, smell and overall impression of both recipes as neutral or positive. Most scores were 4 or 5 out of 5, meaning ‘like’ or ‘like extremely’.

    Six children tasted the products by mouth; the others were fully tube fed. Most of these six scored the taste 4 or 5 out of 5. One child scored it 1, but this child had a severe food aversion before the study.

    Ease of use
    Families rated the products as easy to open, give and use in place of home-blended meals. They valued the convenience, the saved preparation time, and being able to give the product easily at school, in hospital and on days out. Every family that completed said they would use the products if available on NHS prescription.

    The only difficulty reported was the thickness of the product. Two families found it hard to push through the tube with a syringe, and one added around 50ml of water or milk to help it flow, so it could be given by the child. Two families rated the flow poorly for this reason.

    What did healthcare teams think?
    Dietitians judged that 22 of 23 children (96%) tolerated Chicken Casserole well, and 23 of 25 children (92%) tolerated Vegetable Bake well. They were satisfied with the outcome for every child reviewed and supported continued use for nearly all children.

    What medical problems did participants have?
    Eight adverse events (unwanted symptoms) were recorded during the Chicken Casserole periods. One was likely related to the product: a child with stomach pain and constipation who stopped the study. The other seven were judged possibly related or unrelated, for example a stomach bug.

    Five adverse events were recorded during the Vegetable Bake periods. Two were likely related to the product: both children developed loose stools and stopped the study. One of these children had completed the Chicken Casserole period without any problems.

    In total, 3 of the 27 children withdrew from the study. No serious safety concerns were identified.

    How has this study helped patients and researchers?
    This study shows that these real-food enteral products were well tolerated and acceptable to the large majority of children and families who tried them. It gives families and dietitians evidence to support a convenient, nutritionally complete alternative to home blending or standard enteral formula.

    The results have been included in an application to the Advisory Committee on Borderline Substances (ACBS). This is the national committee that decides whether products like this can be prescribed on the NHS.

    Details of any further research planned
    Future work may look at longer-term use of these products and at larger groups of children. The feedback on product thickness will also be used to improve how the product is given.

    Where can I learn more about this study?
    If you would like more information, please contact the research team at Nottingham University Hospitals NHS Trust, or speak to your child’s dietitian. You can also find information about the products at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.wilbosblends.com%2F&data=05%7C02%7Capprovals%40hra.nhs.uk%7C4476232ee0c548f01d4608decbb9899a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639172194924406692%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6Yi%2B5Z5X13DBhQopnyUKRMngnVW%2BKyP%2FV6M4pNC%2BV54%3D&reserved=0.

  • REC name

    West of Scotland REC 1

  • REC reference

    25/WS/0138

  • Date of REC Opinion

    3 Oct 2025

  • REC opinion

    Further Information Favourable Opinion