The Nutritional Health for the Elderly Reference Centre Study (NHERC Study)

Completed

• Conditions: Malnutrition

• Registration Number: NCT03240952
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-07
• Study Start: 2017-08-30
• Primary Completion: 2018-05-28
• Study Completion: 2018-07-26
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MUST	Baseline	Malnutrition risk using Malnutrition Universal Screening Tool

Secondary Outcome Measures

Name	Time	Method
Body weight, fat mass, fat free mass	Baseline	Body weight, fat mass, fat free mass in kilograms will be measured using Tanita MC-780
Pre-albumin	Baseline	Pre-albumin in mg/dL will be measured using Cobas
Albumin and total protein	Baseline	Albumin and total protein in g/L will be measured using Cobas

Trial Locations

Locations (4)

Marine Parade Polyclinic; 🇸🇬 Singapore, Singapore

Bedok Polyclinic; 🇸🇬 Singapore, Singapore

Changi General Hospital; 🇸🇬 Singapore, Singapore

Tampines Polyclinic; 🇸🇬 Singapore, Singapore