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| Name | Class |
|---|---|
| Gadjah Mada University | OTHER |
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The goal of this clinical trial is to compare the effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on nutritional status and inflammatory response in head and neck cancer patients receiving radiotherapy. The main questions it aims to answer are:
Participants will participants will receive ONS in powder form ready to brew as much as 2 servings per day for 3 weeks.
Researchers will compare the effect of giving ONS containing immunonutrients compared to standard ONS to see the effect on nutritional status and inflammatory response
The intervention group received ONS which contained immunonutrients with a composition consisting of purple sweet potato flour, egg white flour, whey protein, olive oil, omega 3 powder, sugar, and creamer. While the control group received a placebo in the form of standard ONS (isocaloric) with a composition of powdered skim milk, coconut oil, sugar, maltodextrin, and creamer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunonutrients ONS | Experimental | the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin) |
|
| standard ONS | Active Comparator | the control group received standard ONS (isocaloric) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunonutrients oral nutritional supplements | Dietary Supplement | 1 serving of ONS immunonutrients which is 57 grams of ready-to-brew powder yields 200 ml of a liquid formula containing 251 kcal energy (1.26 kcal/ml), 9 grams protein (14%), 94 mg omega-3, and 20 mg anthocyanins. |
| Measure | Description | Time Frame |
|---|---|---|
| weight change | The differences in body weight after and before the intervention was given. Weight in kilograms will be measured with digital scales Omron Type HBF 378. | immediately after the intervention |
| Body mass index (BMI) | Calculation of nutritional status using the ratio of body weight (kg) to height squared (m2), where body weight is measured using an digital scales Omron Type HBF 378 and height is measured with a stadiometer. | immediately after the intervention |
| mid-upper arm circumference (MUAC) | the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromion). MUAC is measured using a metline in centimeters. | immediately after the intervention |
| handgrip strength | a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit. | immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuadiyah Nila, MPH | Contact | +6282226868412 | fuadiyah_nila.fk@ub.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Fuadiyah Nila, MPH | Gadjah Mada University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| dr. Sardjito General Hospital | Recruiting | Yogyakarta | DI Yogyakarta | 55284 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 1, 2022 | Feb 6, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| standard oral nutritional supplements | Dietary Supplement | 1 serving of standard ONS which is 57 grams of ready-to-brew powder yields 200 ml of liquid formula containing 258 kcal energy (1.26 kcal/ml), 5 g (7.5%) protein , 7 g (24%) fat, 43 g (68%) carbohydrate |
|