- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240952
The Nutritional Health for the Elderly Reference Centre Study (NHERC Study) (NHERC)
April 13, 2020 updated by: Abbott Nutrition
Establishing Reference Range for Community-dwelling Elderly Nutrition
Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient requirements concomitant with a reduction in energy requirements, decreases in appetite and energy intake.
Currently there is a gap in knowledge of the factors that are associated with malnutrition in the elderly in Singapore.
In addition, there is no "reference" database on anthropometric measurements and biochemical indices for elderly with a range of nutrition status in Singapore.
Thus, the objectives of this cross-sectional study are to examine factors influencing nutritional status and to determine the reference values for anthropometric and biochemical measurements related to nutritional status for community-dwelling elderly in Singapore.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a cross-sectional study.
Measurements will be taken at baseline for elderly with normal nutrition (n = 400) and elderly who are at risk of under nutrition (n = 800)..
These measurements will be used to examine factors influencing nutritional status and to create a "reference" database for anthropometric and biochemical measurements related to nutritional status for use in clinical practice.
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 529889
- Changi General Hospital
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Singapore, Singapore, 440080
- Marine Parade Polyclinic
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Singapore, Singapore, 460212
- Bedok Polyclinic
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Singapore, Singapore, 529203
- Tampines Polyclinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 110 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This cross-sectional study will include 400 elderly with normal nutrition (MUST score: 0) and 800 elderly who are at risk of undernutrition (MUST score ≥ 1).
Community-dwelling elderly recently discharged from the hospital as well as those who recently visited polyclinics in Singapore will be recruited for the study.
Description
Inclusion Criteria:
- Male or female participant aged ≥65 years.
- Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
- Participant is being discharged home directly (applicable for hospital cohort).
- Participant is community ambulant with or without aid.
- Participant does not have any chronic disease(s) or has stable chronic disease(s) including hypertension, chronic obstructive pulmonary disease, and cardiovascular disease in the opinion of the Study Physician, at study entry.
- Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) and provided authorization prior to any participation in the study.
- Participants will be able to communicate and follow instructions.
- Participant is able to consume food and beverages orally.
Exclusion Criteria:
- Participant has been diagnosed with dementia according to medical records.
- Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
- Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
- Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
- Participant has been diagnosed with end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the screening according to medical records.
- Participant has malignancy according to medical records.
- Participant has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
- Participant is taking part in another study that has not been approved as a concomitant study by the study team.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MUST
Time Frame: Baseline
|
Malnutrition risk using Malnutrition Universal Screening Tool
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight, fat mass, fat free mass
Time Frame: Baseline
|
Body weight, fat mass, fat free mass in kilograms will be measured using Tanita MC-780
|
Baseline
|
Pre-albumin
Time Frame: Baseline
|
Pre-albumin in mg/dL will be measured using Cobas
|
Baseline
|
Albumin and total protein
Time Frame: Baseline
|
Albumin and total protein in g/L will be measured using Cobas
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Siew Ling Tey, Ph.D., Abbott Nutrition Research & Development
- Principal Investigator: Samuel TH Chew, MB.BCh.BAO, Changi General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2017
Primary Completion (Actual)
May 28, 2018
Study Completion (Actual)
July 26, 2018
Study Registration Dates
First Submitted
August 1, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 7, 2017
Study Record Updates
Last Update Posted (Actual)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 13, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL35 (Part 1)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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