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

A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly

The prevalence of malnutrition among the elderly in Asia is high. The objective of this randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of consuming an adult ONS plus dietary counseling (intervention group) for 180 days on nutritional status and unexpected hospital (re)admission, compared with a placebo supplement plus dietary counseling (control group).

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Oral Nutritional Supplement with AN 777; Other: Oral Nutritional Supplement

Detailed Description

This randomized controlled trial will involve 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants will be randomized to intervention group vs. control group at the baseline visit at the clinical trial research unit where baseline measurements and baseline survey using the study specific questionnaires will be performed. Participants will be followed up prospectively at Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit). Repeated measures will be performed at the pre-defined time points. Intention-to-treat analysis comparing intervention group vs. control group will be performed to study the effect of ONS on primary composite outcome consisting of (i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The effect of ONS on nutritional status will be examined by comparing the biochemical and anthropometric measurements of intervention group vs. control group at Day 180. Other outcomes such as changes in functional assessment, nutritional knowledge levels, and quality of life will also be examined. There will be a follow up visit at Day 360.

• Study Type: Interventional
• Enrollment (Actual): 811
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.
9. Participant has been identified as at risk of undernutrition as defined by Malnutrition Universal Screening Tool.
10. Participant is willing to refrain from taking non-study oral nutritional supplements including protein powder over the entire course of the study.
11. Participant is able and willing to follow study procedures and record data in diary and complete any forms or assessments needed throughout the study, with or without the help of the caregivers.

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.
9. Participant has been diagnosed or is known to be allergic or intolerant to milk products.
10. Participant has continuous ONS usage for 30 days prior to the screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Dietary Supplement: Oral Nutritional Supplement with AN777 Participants in the intervention group will be asked to consume two servings of oral nutritional supplement per day for 180 days. (Oral Consumption)	Dietary supplement: Oral Nutritional Supplement with AN 777; Oral Nutritional Supplement with AN 777, 2 servings a day
Placebo Comparator: Control group; Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)	Other: Oral Nutritional Supplement; Oral Nutritional Supplement, 2 servings a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary composite outcome consisting of change in body weight and unexpected hospital admission	(i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)	baseline to Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass and fat free mass	Fat mass and fat free mass in kilograms will be measured using Tanita MC-780	Baseline, 30 days, 90 days and 180 days]
Length of stay of unexpected hospital admission(s)	Unexpected admission to the hospital over 90-day and 180-day intervention periods	90 days & 180 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Collaborators: Changi General Hospital; SingHealth Polyclinics
• Investigators: Principal Investigator: Samuel TH Chew, MB.BCh.BAO, Changi General Hospital; Study Chair: Agnes Siew Ling Tey, Ph.D., Abbott Nutrition Research & Development

Publications and helpful links

General Publications

• Chew STH, Tan NC, Cheong M, Oliver J, Baggs G, Choe Y, How CH, Chow WL, Tan CYL, Kwan SC, Husain FS, Low YL, Huynh DTT, Tey SL. Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition. Clin Nutr. 2021 Apr;40(4):1879-1892. doi: 10.1016/j.clnu.2020.10.015. Epub 2020 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL35 (Part 2)

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