Sedentary EmployeesNCT06780618
The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
A study testing RICE in people with Sedentary Employees and Postprandial Oxidation and inflammation, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. The main question it aims to answer is: Does eating brown rice change MDA and IL-6 levels differently than eating white rice in people who don't exercise much?… Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Employees, Postprandial Oxidation and inflammation
- What is being tested?
- RICE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy administrative employees,
- age 21-59 years,
- normal body mass index (18.5-22.9 kg/m2),
- low physical activity (≤600 METs minutes/week),
- assign for informed consent
Who cannot join
- being pregnant/breastfed/menopause,
- consumption of herbal medicines and/or supplements within 24 hours before data collection,
- having history of DM, CVD, cancer, and autoimmune disease,
- being vegan,
- smoking/alcohol drinking,
- allergic to research food's ingredients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine University of Indonesia
Jakarta, Jakarta Special Capital Region
Wulandari Taradita, MD, +62 82112409854, wulantardit@gmail.com
Rizqa F Putri, MD, +62 81325090874, rizqafebriliany@gmail.com
About this study
Official title: The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
The goal of this clinical trial is to learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. The main question it aims to answer is:
Does eating brown rice change MDA and IL-6 levels differently than eating white rice in people who don't exercise much?
Read more
Participants will:
Be interviewed to collect personal data, medical history, lifestyle habits, and dietary patterns.
Be measured to calculate Body Mass Index (BMI). Be interviewed to complete a questionnaire to assess their physical activity level in the past week.
Be interviewed to record all food and beverages consumed in the past 24 hours. Blood samples will be drawn twice, before and after consuming the research meal.
Be provided with a research meal consisting of rice (either brown or white), scrambled eggs, and tofu stew that must be finished within 15 to 20 minutes.
- Being tested
- RICE, rice wheat (placebo)
- Keywords
- brown rice, white rice, interleukin-6, malondialdehyde, sedentary, inflammation, oxidative stress, postprandial
- Medical subject headings
- Sedentary Behavior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICEOther
150 g of brown rice from Aek Sibundong variant at once
rice wheat (placebo)Other
150 g of white rice from Setra Ramos variant at once
| Study group | Role | What they receive |
|---|---|---|
| brown rice | Active comparator | Not described Receives: Other: RICE |
| white rice | Placebo comparator | Not described Receives: Other: rice wheat (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
Measured: Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start6 Jan 2025
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary EmployeesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wulandari Taradita, Universitas Indonesia
- Investigators
- Wulandari Taradita, MD, Principal investigator, Department of Nutrition Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780618
- Sponsor's protocol ID
- 24-10-1628
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
- ClinicalTrials.gov ID
- NCT06780618
- Acronym / sponsor ID
- 24-10-1628
- Keywords
- brown rice, white rice, interleukin-6, malondialdehyde, sedentary, inflammation, oxidative stress, postprandial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Jan 2025 (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 learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. The main question it aims to answer is:
Does eating brown rice change MDA and IL-6 levels differently than eating white rice in people who don't exercise much?
Participants will:
Be interviewed to collect personal data, medical history, lifestyle habits, and dietary patterns.
Be measured to calculate Body Mass Index (BMI). Be interviewed to complete a questionnaire to assess their physical activity level in the past week.
Be interviewed to record all food and beverages consumed in the past 24 hours. Blood samples will be drawn twice, before and after consuming the research meal.
Be provided with a research meal consisting of rice (either brown or white), scrambled eggs, and tofu stew that must be finished within 15 to 20 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brown rice | Active comparator | Other: RICE |
| white rice | Placebo comparator | Other: rice wheat (placebo) |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy administrative employees,
- age 21-59 years,
- normal body mass index (18.5-22.9 kg/m2),
- low physical activity (≤600 METs minutes/week),
- assign for informed consent
Key exclusion criteria (6 listed)
- being pregnant/breastfed/menopause,
- consumption of herbal medicines and/or supplements within 24 hours before data collection,
- having history of DM, CVD, cancer, and autoimmune disease,
- being vegan,
- smoking/alcohol drinking,
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 |
|---|---|---|
| RICE150 g of brown rice from Aek Sibundong variant at once | Other | brown rice |
| rice wheat (placebo)150 g of white rice from Setra Ramos variant at once | Other | white rice |
Primary outcome
The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
Time frame: Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
Wulandari Taradita, MD principal investigator
Department of Nutrition Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RICE in people with Sedentary Employees and Postprandial Oxidation and inflammation, run by Universitas Indonesia 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rizqa F Putri, MD (+62 81325090874, rizqafebriliany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers (time frame: Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.). 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 Jan 2025.