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| Name | Class |
|---|---|
| Changi General Hospital | OTHER |
| SingHealth Polyclinics | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutritional Supplement with AN 777 | Dietary Supplement | Oral Nutritional Supplement with AN 777, 2 servings a day |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Siew Ling Tey, Ph.D. | Abbott Nutrition Research & Development | Study Chair |
| Samuel TH Chew, MB.BCh.BAO | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marine Parade Polyclinic | Singapore | 440080 | Singapore | |||
| Bedok Polyclinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36564733 | Derived | 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. | |
| 33268143 | 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. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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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.
| Oral Nutritional Supplement | Other | Oral Nutritional Supplement, 2 servings a day |
|
Unexpected admission to the hospital over 90-day and 180-day intervention periods
| 90 days & 180 days |
| Singapore |
| 460212 |
| Singapore |
| Tampines Polyclinic | Singapore | 529203 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |