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

Malnutrition Clinical Trial

— NHERC  

Official title:

Establishing Reference Range for Community-dwelling Elderly Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240952
• Other study ID #: BL35 (Part 1)
• Status: Completed
• Start date: August 30, 2017
• Est. completion date: July 26, 2018

Study information

• Verified date: April 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 26, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Singapore	Bedok Polyclinic	Singapore
Singapore	Changi General Hospital	Singapore
Singapore	Marine Parade Polyclinic	Singapore
Singapore	Tampines Polyclinic	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Nutrition	Changi General Hospital, SingHealth Polyclinics

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MUST	Malnutrition risk using Malnutrition Universal Screening Tool	Baseline
Secondary	Body weight, fat mass, fat free mass	Body weight, fat mass, fat free mass in kilograms will be measured using Tanita MC-780	Baseline
Secondary	Pre-albumin	Pre-albumin in mg/dL will be measured using Cobas	Baseline
Secondary	Albumin and total protein	Albumin and total protein in g/L will be measured using Cobas	Baseline