NCT06780618

Brief 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? 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 13, 2025

Last Update Submit

January 21, 2025

Conditions

Keywords

brown ricewhite riceinterleukin-6malondialdehydesedentaryinflammationoxidative stresspostprandial

Outcome Measures

Primary Outcomes (1)

  • The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers

    Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.

Study Arms (2)

brown rice

ACTIVE COMPARATOR
Other: RICE

white rice

PLACEBO COMPARATOR
Other: rice wheat (placebo)

Interventions

RICEOTHER

150 g of brown rice from Aek Sibundong variant at once

brown rice

150 g of white rice from Setra Ramos variant at once

white rice

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine University of Indonesia

Jakarta, Jakarta Special Capital Region, Indonesia

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorInflammation

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wulandari Taradita, MD

    Department of Nutrition Faculty of Medicine University of Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

January 6, 2025

Primary Completion

March 31, 2025

Study Completion

April 30, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations