Oral Nutritional Supplement
Conditions
Keywords
oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato
Brief summary
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: * Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on the nutritional status? * Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on inflammatory response? 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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTstandard oral nutritional supplements
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
DIETARY_SUPPLEMENTimmunonutrients oral nutritional supplements
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.
Sponsors
Gadjah Mada University
University of Brawijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy 2. Participant aged 18-80 years 3. Participant can consume food, either through a nasogastric tube (NGT) or orally
Exclusion criteria
1. Participant has a milk or egg allergy 2. Participant with comorbid renal impairment and/or diabetes mellitus 3. Participant with poor nutritional status with BMI \< 17.0 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight change | immediately after the intervention | 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. |
| Body mass index (BMI) | immediately after the intervention | 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. |
| mid-upper arm circumference (MUAC) | immediately after the intervention | 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. |
| handgrip strength | immediately after the intervention | a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit. |
Countries
Indonesia
Contacts
Primary ContactFuadiyah Nila, MPH
Outcome results
None listed