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An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition

NCT ID: NCT01079260

Last Updated: 2014-11-13

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-06-30

Brief Summary

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This study aims to investigate the efficacy of high energy, low volume oral nutritional supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake, compliance, gastro intestinal tolerance and function, in participants at risk of malnutrition.

Detailed Description

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In current clinical practice malnourished (undernourished) patients may receive oral nutritional supplements (ONS) to aid in the management of their malnutrition (undernutrition). Poor compliance to ONS was been reported in the scientific literature, however recent studies of a low volume, high energy ONS have shown high compliance. This study aims to further explore compliance to low volume ONS compared to standard ONS. This study is a 2 week cross over study with a 4 week optional extension. Participants at risk of malnutrition will receive a low volume, high energy ONS for 1 week and a standard ONS for 1 week in a random order to compare nutrient intake and compliance. This short term element of the study was designed based on a similar study by Hubbard et al 2009, where significant differences in compliance and energy intake were observed. Participants may then take part in an optional 4 week extension period where they will receive their preferred ONS for 4 weeks. Longer term outcomes such as change in weight, muscle function and tolerance to the ONS will be measured in this part of the study. Changes in weight and muscle function are typically seen in 4 weeks.

Overview of the study:

1. Participants will be assessed for inclusion and exclusion criteria by the investigating dietitian or research nurse, and then provided with information about the study. Eligible participants will be asked for their written informed consent. Participant characteristics and medical history will be collected.
2. Participants will be randomly allocated to receive either:

A. A standard ONS (1.5kcal/ml) as control, ad libitum in addition to diet for 7 days. Participants will then receive the high energy, low volume equivalent ONS (2.4kcal/ml) ad libitum in addition to diet for 7 days (n=70), or:

B. A high energy, low volume ONS (2.4kcal/ml) ad libitum in addition to diet for 7 days. Participants will then receive the equivalent standard ONS (1.5kcal/ml) as control, ad libitum in addition to diet for 7 days (n=70). Participants will then have an option to continue with their preferred ONS for a further 4 weeks (28 days).

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard ONS

Group Type ACTIVE_COMPARATOR

Standard ONS

Intervention Type DIETARY_SUPPLEMENT

Standard ONS

High Energy, Low volume ONS

High energy, low volume ONS

Group Type EXPERIMENTAL

High Energy, low volume ONS

Intervention Type DIETARY_SUPPLEMENT

High energy, low volume ONS

Interventions

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Standard ONS

Standard ONS

Intervention Type DIETARY_SUPPLEMENT

High Energy, low volume ONS

High energy, low volume ONS

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ONS sip feeds Oral nutritional supplements ONS Sip feeds Oral nutritional supplements

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age \> 18 years
* At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1)
* Competent to provide written informed consent and able to answer questions
* No requirement for tube or parenteral feeding
* Willingness to take part in the study and to follow the study protocol

Exclusion Criteria

* Requirement for tube or parenteral nutrition
* Participants receiving palliative care
* Participants with chronic renal disease requiring dialysis
* Participants with liver failure
* Participants that are pregnant or lactating
* Participation in other studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia UK Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Stratton

Role: PRINCIPAL_INVESTIGATOR

Nutricia UK Ltd

Locations

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Dietetics Dept, Great Western Hospital

Swindon, Wiltshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NCC300

Identifier Type: -

Identifier Source: org_study_id