- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06780618
The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
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?
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rizqa F Putri, MD
- Phone Number: +62 81325090874
- Email: rizqafebriliany@gmail.com
Study Locations
-
-
-
Jakarta, Indonesia
- Recruiting
- Faculty of Medicine University of Indonesia
-
Contact:
- Rizqa F Putri, MD
- Phone Number: +62 81325090874
- Email: rizqafebriliany@gmail.com
-
Contact:
- Wulandari Taradita, MD
- Phone Number: +62 82112409854
- Email: wulantardit@gmail.com
-
Contact:
- Wulandari Taradita, MD
-
Contact:
- Rizqa F Putri, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: brown rice
|
150 g of brown rice from Aek Sibundong variant at once
|
|
Placebo Comparator: white rice
|
150 g of white rice from Setra Ramos variant at once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wulandari Taradita, MD, Department of Nutrition Faculty of Medicine University of Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-10-1628
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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