- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01079260
An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition
An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wiltshire
-
Swindon, Wiltshire, United Kingdom, SN3 6BB
- Dietetics Dept, Great Western Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard ONS
|
Standard ONS
Other Names:
|
Experimental: High Energy, Low volume ONS
High energy, low volume ONS
|
High energy, low volume ONS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutrient intake (energy, protein and micronutrients)
Time Frame: 1week
|
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.
|
1week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with ONS
Time Frame: 1week
|
Participants' compliance with ONS (percentage of bottle consumed), will be recorded on a daily basis by the participant or their carer throughout the study.
|
1week
|
ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred)
Time Frame: 1week
|
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
|
1week
|
Appetite
Time Frame: 1week
|
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).
|
1week
|
Anthropometry
Time Frame: 6weeks
|
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.
|
6weeks
|
Muscle Strength (Hand Grip Strength)
Time Frame: 6weeks
|
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.
|
6weeks
|
Gastro-intestinal (GI) tolerance
Time Frame: 6weeks
|
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.
|
6weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Stratton, Nutricia UK Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
-
International Centre for Diarrhoeal Disease Research...UNICEFNot yet recruitingMalnutrition SevereBangladesh
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Academy of Nutrition and DieteticsHartford Hospital; University of New Mexico; Meals on Wheels Central TexasNot yet recruiting
-
Diego MorettiSwiss Federal Institute of Technology; Wageningen University and Research; St... and other collaboratorsCompletedMalnutrition; ProteinSwitzerland
-
International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh
-
Microbiome Health Research InstituteUniversity of Cape TownTerminatedModerate Acute Malnutrition | Severe Acute MalnutritionSouth Africa
Clinical Trials on Standard ONS
-
Danone Specialized NutritionCompleted
-
Abbott NutritionAdvocate Health CareTerminatedQuality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized PatientsMalnutritionUnited States
-
Abbott NutritionCompleted
-
National Medical Research Radiological Centre of...CompletedHead and Neck Cancer | Radiotherapy; ComplicationsRussian Federation
-
Nutricia UK LtdCompleted
-
Stanley Dudrick's Memorial HospitalRecruiting
-
International Medical UniversityKotra Pharma (M) Sdn BhdCompletedCancer of Breast | Cancer ColonMalaysia
-
Abbott NutritionCompleted
-
Nottingham University Hospitals NHS TrustCompletedMalnutrition | Femoral Fragility FracturesUnited Kingdom
-
Wageningen UniversityVitalnextUnknownMalnutrition | Muscle HealthNetherlands