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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 440080
        • Marine Parade Polyclinic
      • Singapore, Singapore, 460212
        • Bedok Polyclinic
      • Singapore, Singapore, 529203
        • Tampines Polyclinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Male or female participant aged ≥65 years.
  2. Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
  3. Participant is being discharged home directly (applicable for hospital cohort).
  4. Participant is community ambulant with or without aid.
  5. 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.
  6. 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.
  7. Participants will be able to communicate and follow instructions.
  8. Participant is able to consume food and beverages orally.

Exclusion Criteria:

  1. Participant has been diagnosed with dementia according to medical records.
  2. Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
  3. Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
  4. Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
  5. 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.
  6. Participant has malignancy according to medical records.
  7. Participant has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
  8. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MUST
Time Frame: Baseline
Malnutrition risk using Malnutrition Universal Screening Tool
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changi General Hospital
SingHealth Polyclinics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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