Acceptability and Tolerance of New Oral Nutritional Supplement

NCT02639156 | Completed

• 1 other identifier: AY:SPT1
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• GI Side Effects when using AYMES LONDON

  Recording of any nausea, vomiting, abdominal pain, bloating / flatulence when using AYMES LONDON as assessed by presence / absence of side effect compared to baseline period

  9 days

Secondary Outcomes (3)

• Change to bodyweight of subjects when using AYMES LONDON

  9 DAYS

• Compliance with prescription of AYMES LONDON

  9 days

• Bowel habits of subjects when using AYMES LONDON

  9 days

Study Arms (1)

intervention

EXPERIMENTAL

Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day will be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days.

Dietary Supplement: AYMES LONDON

Interventions

AYMES LONDON DIETARY_SUPPLEMENT

AYMES LONDON is a powder, designed to be mixed with 75ml whole milk to make a dessert style ONS. When made-up, AYMES LONDON provides 303kcal (2.2kcal/ml) and 11.2g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
• Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day
• Patients expected to require oral nutritional supplementation for at least 2 further weeks.
• Informed consent obtained

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Aymes International Limited: lead
• Alison Clark Health and Nutrition: collaborator

Related Publications (7)

• Stratton RJ, Green CJ, Elia M. Disease-related malnutrition: an evidence based approach to treatment. Wallingford: CABI Publishing; 2003.

  BACKGROUND

• National Institute for Health and Care Excellence (NICE). Nutrition support in adults: oral nutrition support, enteral tube feeding and parenteral nutrition (clinical guideline 32). 2006. London, National Institute for Health and Clinical Excellence (NICE).

  BACKGROUND

• Stratton RJ, Elia M. A review of reviews: A new look at the evidence for oral nutritional supplements in clinical practice. Clin Nutr 2007; 2(Suppl 1):5-23.

  BACKGROUND

• Gazzotti C, Arnaud-Battandier F, Parello M, Farine S, Seidel L, Albert A, Petermans J. Prevention of malnutrition in older people during and after hospitalisation: results from a randomised controlled clinical trial. Age Ageing. 2003 May;32(3):321-5. doi: 10.1093/ageing/32.3.321.

  PMID: 12720620 BACKGROUND

• Manders M, de Groot CP, Blauw YH, Dhonukshe-Rutten RA, van Hoeckel-Prust L, Bindels JG, Siebelink E, van Staveren WA. Effect of a nutrient-enriched drink on dietary intake and nutritional status in institutionalised elderly. Eur J Clin Nutr. 2009 Oct;63(10):1241-50. doi: 10.1038/ejcn.2009.28. Epub 2009 May 20.

  PMID: 19455176 BACKGROUND

• Wouters-Wesseling W, Wouters AE, Kleijer CN, Bindels JG, de Groot CP, van Staveren WA. Study of the effect of a liquid nutrition supplement on the nutritional status of psycho-geriatric nursing home patients. Eur J Clin Nutr. 2002 Mar;56(3):245-51. doi: 10.1038/sj.ejcn.1601319.

  PMID: 11960300 BACKGROUND

• Hubbard GP, Elia M, Holdoway A, Stratton RJ. A systematic review of compliance to oral nutritional supplements. Clin Nutr. 2012 Jun;31(3):293-312. doi: 10.1016/j.clnu.2011.11.020. Epub 2012 Jan 17.

  PMID: 22257636 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Alison Clark, BSc (Hons)

  Alison Clark Health and Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 24, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-08