Malnutrition Clinical Trial
— NHERCOfficial title:
A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly
Verified date | March 2021 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 811 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 110 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Bedok Polyclinic | Singapore | |
Singapore | Changi General Hospital | Singapore | |
Singapore | Marine Parade Polyclinic | Singapore | |
Singapore | Tampines Polyclinic | Singapore |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition | Changi General Hospital, SingHealth Polyclinics |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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] | |
Secondary | 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 |
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