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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Nutricia UK Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nutricia UK Ltd
ClinicalTrials.gov Identifier:
NCT01079260
First received: February 25, 2010
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Standard ONS
Dietary Supplement: High Energy, low volume ONS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition

Resource links provided by NLM:


Further study details as provided by Nutricia UK Ltd:

Primary Outcome Measures:
  • Nutrient intake (energy, protein and micronutrients) [ Time Frame: 1week ] [ Designated as safety issue: No ]
    Dietary intake, including the intake of all foods, drinks and ONS will be recorded at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the optional extension period (week 6) using 24 hr dietary recall. A dietary analysis program will be used to calculate intake from food and total dietary intake.


Secondary Outcome Measures:
  • Compliance with ONS [ Time Frame: 1week ] [ Designated as safety issue: No ]
    Participants' compliance with ONS (percentage of bottle consumed), will be recorded on a daily basis by the participant or their carer throughout the study.

  • ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred) [ Time Frame: 1week ] [ Designated as safety issue: No ]
    The acceptability (taste, texture, aroma) and preference for the type of ONS will be assessed (using Yes/No questions and visual analogue scales) to gather patients feedback on the acceptability the the supplements

  • Appetite [ Time Frame: 1week ] [ Designated as safety issue: No ]
    The effect of the ONS on hunger and fullness will be assessed by questionnaire using visual analogue scales at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the study (week 6).

  • Anthropometry [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
    At baseline as part of screening with MUST, at the end of week 1, at the end of week 2 and at the end of the study (week 6), body weight (kg) will be measured using standard methods and body mass index (kg/m2) calculated. Body weight will be measured to the nearest 0.1kg using a weighing scale or weighing chair without shoes or heavy clothing.

  • Muscle Strength (Hand Grip Strength) [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
    Hand grip strength will be measured at baseline (day 1), at the end of week 2 and at the end of the study (week 6) using a handgrip dynamometer.

  • Gastro-intestinal (GI) tolerance [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]
    Gastro-intestinal tolerance will be assessed at baseline (day 1), at the end of week 1, at the end of week 2 and the end of week 6 for 1 day, using a standardized GI tolerance questionnaire.


Estimated Enrollment: 140
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard ONS Dietary Supplement: Standard ONS
Standard ONS
Other Names:
  • ONS
  • sip feeds
  • Oral nutritional supplements
Experimental: High Energy, Low volume ONS
High energy, low volume ONS
Dietary Supplement: High Energy, low volume ONS
High energy, low volume ONS
Other Names:
  • ONS
  • Sip feeds
  • Oral nutritional supplements

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079260

Locations
United Kingdom
Dietetics Dept, Great Western Hospital Recruiting
Swindon, Wiltshire, United Kingdom, SN3 6BB
Contact: Natalie Harwood    01793539214    natalie.harwood@nhs.net   
Principal Investigator: Natalie Harwood         
Sponsors and Collaborators
Nutricia UK Ltd
Investigators
Principal Investigator: Rebecca Stratton Nutricia UK Ltd
  More Information

No publications provided

Responsible Party: Nutricia UK Ltd
ClinicalTrials.gov Identifier: NCT01079260     History of Changes
Other Study ID Numbers: NCC300
Study First Received: February 25, 2010
Last Updated: August 23, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Nutricia UK Ltd:
Malnourished
Elderly
Nutrition support

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 20, 2014