DepressionNCT05180136
Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults
A study testing Rice bran extract group in people with Depression, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Rice bran extract group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2022to 31 Dec 2022
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the Korean version of the Hamilton Depression Rating Scale score between 7-24
Who cannot join
- No depressive symptom (K-HRSD ≤ 6) or severely depressed (K-HRSD ≥ 25)
- Those are taking hormone therapy such as estrogen within the past 6 months
- Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.)
- Those with a history of treatment for depression
- Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
Show all 15Show fewer
- Uncontrolled hypertension (>160/100 mmHg)
- Uncontrolled thyroid diseases.
- Those who are taking drugs, functional foods, herbs, etc. that may affect depression
- Alcohol abuser
- Allergic reaction to this test food
- Those who participated in other drug clinical trials within 1 month from the screening date.
- Severe gastrointestinal symptoms such as heartburn and indigestion
- Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- Those who are judged to be unsuitable by the PI for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.
Read the detailed description
A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.
- Conditions
- Depression
- Being tested
- Rice bran extract group, Control group
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice bran extract groupDietary supplement
Rice bran extract 1,000 mg/day for 8 weeks
Control groupDietary supplement
Placebo 1,000 mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rice bran extract group | Experimental | This group takes rice bran extract for 8 weeks. Receives: Dietary Supplement: Rice bran extract group |
| Control group | Placebo comparator | This group takes a placebo for 8 weeks. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome.
Measured: 8 weeks
Secondary outcomes (8)
The Korean Version of the Beck-II Depression Inventory (K-BDI II)
using K-BDI II score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.
Measured: 8 weeks
The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)
using K-PHQ-9 score. The minimum score was 0 and the maximum score was 27, and higher scores mean a worse outcome.
Measured: 8 weeks
The Korean version of the Beck Anxiety Inventory (K-BAI)
using K-BAI score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.
Measured: 8 weeks
The Korean of the Perceived Stress Scale(K-PSS)
using K-PSS score. The minimum score was 0 and the maximum score was 40, and higher scores mean a worse outcome.
Measured: 8 weeks
serotonin concentration (nM)
Change during 8 weeks
Measured: 8 weeks
Brain-derived neurotrophic factor concentration (ng/ml)
Change during 8 weeks
Measured: 8 weeks
salivary cortisol concentration (U/mL)
Change during 8 weeks
Measured: 8 weeks
dopamine concentration (pg/μL)
Change during 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start20 Jan 2022
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180136
- Sponsor's protocol ID
- 02-2021-031
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh SY, Lee YL, Kim SH, Lee SY. Efficacy of rice bran extract for alleviating depressive symptoms in adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2025 Jul;122(1):112-121. doi: 10.1016/j.ajcnut.2025.05.021. Epub 2025 May 21.
PubMed 40409466
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05180136
- Acronym / sponsor ID
- 02-2021-031
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jan 2022 (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 investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.
Detailed description
A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice bran extract group | Experimental | Dietary Supplement: Rice bran extract groupThis group takes rice bran extract for 8 weeks. |
| Control group | Placebo comparator | Dietary Supplement: Control groupThis group takes a placebo for 8 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the Korean version of the Hamilton Depression Rating Scale score between 7-24
Key exclusion criteria (15 listed)
- No depressive symptom (K-HRSD ≤ 6) or severely depressed (K-HRSD ≥ 25)
- Those are taking hormone therapy such as estrogen within the past 6 months
- Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.)
- Those with a history of treatment for depression
- Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
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 |
|---|---|---|
| Rice bran extract groupRice bran extract 1,000 mg/day for 8 weeks | Dietary supplement | Rice bran extract group |
| Control groupPlacebo 1,000 mg/day for 8 weeks | Dietary supplement | Control group |
Primary outcome
The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
Time frame: 8 weeks
using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome.
8 secondary outcomes
The Korean Version of the Beck-II Depression Inventory (K-BDI II)
Time frame: 8 weeks
The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)
Time frame: 8 weeks
The Korean version of the Beck Anxiety Inventory (K-BAI)
Time frame: 8 weeks
The Korean of the Perceived Stress Scale(K-PSS)
Time frame: 8 weeks
serotonin concentration (nM)
Time frame: 8 weeks
Brain-derived neurotrophic factor concentration (ng/ml)
Time frame: 8 weeks
salivary cortisol concentration (U/mL)
Time frame: 8 weeks
dopamine concentration (pg/μL)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 40409466Huh SY, Lee YL, Kim SH, Lee SY. Efficacy of rice bran extract for alleviating depressive symptoms in adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2025 Jul;122(1):112-121. doi: 10.1016/j.ajcnut.2025.05.021. Epub 2025 May 21.
- Individual participant dataSharing planned: No
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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.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
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 bran extract group in people with Depression, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 15 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: finished, as of the sponsor's last update on 2 Feb 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Korean version of the Hamilton Depression Rating Scale (K-HDRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180136, which also lists 1 linked publication.
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 2 Feb 2024.