Status:
COMPLETED
The Nutritional Health for the Elderly Reference Centre Study (The NHERC Study)
Lead Sponsor:
Abbott Nutrition
Collaborating Sponsors:
Changi General Hospital
SingHealth Polyclinics
Conditions:
Malnutrition
Eligibility:
All Genders
65-110 years
Phase:
NA
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 ON...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
811 Patients enrolled
Trial Details
Trial ID
NCT03245047
Start Date
August 30 2017
End Date
March 10 2020
Last Update
March 5 2021
Active Locations (4)
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1
Marine Parade Polyclinic
Singapore, Singapore, 440080
2
Bedok Polyclinic
Singapore, Singapore, 460212
3
Tampines Polyclinic
Singapore, Singapore, 529203
4
Changi General Hospital
Singapore, Singapore, 529889