Oral Nutritional SupplementNCT05740878
Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy
A study testing immunonutrients oral nutritional supplements and standard oral nutritional supplements in people with Oral Nutritional Supplement, run by University of Brawijaya at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Nutritional Supplement
- What is being tested?
- immunonutrients oral nutritional supplements and standard oral nutritional supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy
- Participant aged 18-80 years
- Participant can consume food, either through a nasogastric tube (NGT) or orally
Who cannot join
- Participant has a milk or egg allergy
- Participant with comorbid renal impairment and/or diabetes mellitus
- Participant with poor nutritional status with BMI < 17.0 kg/m2
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
dr. Sardjito General Hospital
Yogyakarta, DI Yogyakarta, 55284
Fuadiyah Nila, +6282226868412, fuadiyahnila@gmail.com
About this study
Official title: Effect of Local Food-Based Oral Nutritional Supplements (ONS) Containing Immunonutrients in the Form of Anthocyanin and Omega-3 on Nutritional Status and Inflammatory Response in Head and Neck Cancer Patients Receiving Radiotherapy
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?
Read more
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
Read the 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.
- Conditions
- Oral Nutritional Supplement
- Being tested
- immunonutrients oral nutritional supplements, standard oral nutritional supplements
- Keywords
- oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunonutrients oral nutritional supplementsDietary 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.
standard oral nutritional supplementsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| immunonutrients ONS | Experimental | the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin) Receives: Dietary Supplement: immunonutrients oral nutritional supplements |
| standard ONS | Active comparator | the control group received standard ONS (isocaloric) Receives: Dietary Supplement: standard oral nutritional supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start15 Mar 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Nutritional SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Gadjah Mada University
- Responsible party
- Principal investigator, Fuadiyah Nila Kurniasari, University of Brawijaya
- Investigators
- Fuadiyah Nila, MPH, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740878
- Sponsor's protocol ID
- UBrawijaya
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Food-Based Oral Nutritional Supplements (ONS) Containing Immunonutrients in the Form of Anthocyanin and Omega-3 on Nutritional Status and Inflammatory Response in Head and Neck Cancer Patients Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT05740878
- Acronym / sponsor ID
- UBrawijaya
- Conditions
- Oral Nutritional Supplement
- Keywords
- oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Collaborators
- Gadjah Mada University
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunonutrients ONS | Experimental | Dietary Supplement: immunonutrients oral nutritional supplementsthe intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin) |
| standard ONS | Active comparator | Dietary Supplement: standard oral nutritional supplementsthe control group received standard ONS (isocaloric) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy
- Participant aged 18-80 years
- Participant can consume food, either through a nasogastric tube (NGT) or orally
Key exclusion criteria (3 listed)
- Participant has a milk or egg allergy
- Participant with comorbid renal impairment and/or diabetes mellitus
- Participant with poor nutritional status with BMI < 17.0 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunonutrients oral nutritional supplements1 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. | Dietary supplement | immunonutrients ONS |
| standard oral nutritional supplements1 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 supplement | standard ONS |
Primary outcome
weight change
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: immediately after the intervention
a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuadiyah Nila, MPH principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunonutrients oral nutritional supplements and standard oral nutritional supplements in people with Oral Nutritional Supplement, run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuadiyah Nila, MPH (+6282226868412, fuadiyah_nila.fk@ub.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.