Clinical trial NCT03240952: The Nutritional Health for the Elderly Reference Centre Study (NHERC Study)
Official title: Establishing Reference Range for Community-dwelling Elderly Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Changi General Hospital
name: SingHealth Polyclinics
First posted: 2017-08-07
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MUST
timeFrame: Baseline
Secondary outcomes:
measure: Body weight, fat mass, fat free mass
timeFrame: Baseline
measure: Pre-albumin
timeFrame: Baseline
measure: Albumin and total protein
timeFrame: Baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Marine Parade Polyclinic
city: Singapore
country: Singapore
facility: Bedok Polyclinic
city: Singapore
country: Singapore
facility: Tampines Polyclinic
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Abbott Nutrition Research & Development
name: Siew Ling Tey, Ph.D.
role: STUDY_CHAIR
affiliation: Changi General Hospital
name: Samuel TH Chew, MB.BCh.BAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong RHS, Chow WL, Cheong M, Lim GH, Xie W, Baggs G, Huynh DTT, Oh HC, How CH, Tan NC, Tey SL, Chew STH. Associations between socio-demographics, nutrition knowledge, nutrition competencies and attitudes in community-dwelling healthy older adults in Singapore: findings from the SHIELD study. J Health Popul Nutr. 2021 Dec 11;40(1):52. doi: 10.1186/s41043-021-00277-4.