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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Oral Nutritional Supplement with AN 777
Oral Nutritional Supplement
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marine Parade Polyclinic
  • Bedok Polyclinic
  • Tampines Polyclinic
  • Changi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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)

Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Fat mass and fat free mass
Fat mass and fat free mass in kilograms will be measured using Tanita MC-780
Length of stay of unexpected hospital admission(s)
Unexpected admission to the hospital over 90-day and 180-day intervention periods

Full Information

First Posted
August 1, 2017
Last Updated
March 4, 2021
Sponsor
Abbott Nutrition
Collaborators
Changi General Hospital, SingHealth Polyclinics
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1. Study Identification

Unique Protocol Identification Number
NCT03245047
Brief Title
The Nutritional Health for the Elderly Reference Centre Study (The NHERC Study)
Acronym
NHERC
Official Title
A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
Collaborators
Changi General Hospital, SingHealth Polyclinics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
This study is double-blinded, i.e., during the study, neither the investigator(s), study and appropriate Abbott Nutrition staff, nor participants will be informed of the identity of any of the study products. Study center personnel will not analyze the contents of the study products or in any way seek to learn the identity of the study products. The investigator should ensure that if it becomes necessary, blinding is broken only in accordance with the protocol.
Allocation
Randomized
Enrollment
811 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutritional Supplement with AN 777
Intervention Description
Oral Nutritional Supplement with AN 777, 2 servings a day
Intervention Type
Other
Intervention Name(s)
Oral Nutritional Supplement
Intervention Description
Oral Nutritional Supplement, 2 servings a day
Primary Outcome Measure Information:
Title
Primary composite outcome consisting of change in body weight and unexpected hospital admission
Description
(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)
Time Frame
baseline to Day 180
Secondary Outcome Measure Information:
Title
Fat mass and fat free mass
Description
Fat mass and fat free mass in kilograms will be measured using Tanita MC-780
Time Frame
Baseline, 30 days, 90 days and 180 days]
Title
Length of stay of unexpected hospital admission(s)
Description
Unexpected admission to the hospital over 90-day and 180-day intervention periods
Time Frame
90 days & 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participant aged ≥65 years. Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution. Participant is being discharged home directly (applicable for hospital cohort). Participant is community ambulant with or without aid. 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 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. Participants will be able to communicate and follow instructions. Participant is able to consume food and beverages orally. Participant has been identified as at risk of undernutrition as defined by Malnutrition Universal Screening Tool. Participant is willing to refrain from taking non-study oral nutritional supplements including protein powder over the entire course of the study. 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: Participant has been diagnosed with dementia according to medical records. Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.) Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records. Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records. 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. Participant has malignancy according to medical records. Participant has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study. Participant is taking part in another study that has not been approved as a concomitant study by the study team. Participant has been diagnosed or is known to be allergic or intolerant to milk products. Participant has continuous ONS usage for 30 days prior to the screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Siew Ling Tey, Ph.D.
Organizational Affiliation
Abbott Nutrition Research & Development
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Samuel TH Chew, MB.BCh.BAO
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marine Parade Polyclinic
City
Singapore
ZIP/Postal Code
440080
Country
Singapore
Facility Name
Bedok Polyclinic
City
Singapore
ZIP/Postal Code
460212
Country
Singapore
Facility Name
Tampines Polyclinic
City
Singapore
ZIP/Postal Code
529203
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33268143
Citation
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.
Results Reference
derived

Learn more about this trial

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

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