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

NCT03245047 | Completed

• 1 other identifier: BL35 (Part 2)
• Study Type: interventional
• Target: 811
• Locations: 1 country
• Sites: 4

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).

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fat mass and fat free mass

  Baseline, 30 days, 90 days and 180 days]

• Length of stay of unexpected hospital admission(s)

  90 days & 180 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Oral Nutritional Supplement with AN 777 DIETARY_SUPPLEMENT

Oral Nutritional Supplement with AN 777, 2 servings a day

Intervention group

Oral Nutritional Supplement OTHER

Oral Nutritional Supplement, 2 servings a day

Control group

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Abbott Nutrition: lead
• Changi General Hospital: collaborator
• SingHealth Polyclinics: collaborator

Study Sites (4)

Marine Parade Polyclinic

Singapore, 440080, Singapore

Location

Bedok Polyclinic

Singapore, 460212, Singapore

Location

Tampines Polyclinic

Singapore, 529203, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (2)

• Chew STH, Tey SL, Yalawar M, Liu Z, Baggs G, How CH, Cheong M, Chow WL, Low YL, Huynh DTT, Tan NC. Prevalence and associated factors of sarcopenia in community-dwelling older adults at risk of malnutrition. BMC Geriatr. 2022 Dec 24;22(1):997. doi: 10.1186/s12877-022-03704-1.

  PMID: 36564733 DERIVED

• 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.

  PMID: 33268143 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Agnes Siew Ling Tey, Ph.D.

  Abbott Nutrition Research & Development

  STUDY CHAIR

• Samuel TH Chew, MB.BCh.BAO

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 10, 2017
• Study Start: August 30, 2017
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (4)