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Effects of gamma oryzanol mixed with curcumin in healthy volunteers

Effects of gamma oryzanol mixed with curcumin in healthy volunteers

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251223001
Enrollment
100
Registered
2025-12-23
Start date
2022-06-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study was conducted in healthy volunteers to evaluate the health-promoting effects of a supplement containing gamma oryzanol mixed with curcumin. The investigation focused on physiological and biochemical indicators of systemic health, including blood chemistry, renal and kidney function, vitamin B12 levels, and inflammatory biomarker. Neuropsychological assessments were also performed to explore potential executive function. Gamma oryzanol, Curcumin, Dietary supplement, Healthy volunteer

Interventions

Participants in the experimental group received a dietary supplement containing gamma oryzanol mixed with curcumin in capsule form. The dosage was two capsules once daily after a meal. Each capsule co
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Supplement containing gamma oryzanol mixed with curcumin,Placebo capsule identical in appearance, without active ingredients

Sponsors

Naresuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Thai adults aged 20 to 59 years with a body weight of at least 50 kilograms 2. Body mass index (BMI) between 18.51 and 29.99 3. Normal blood pressure (SBP < 140 mmHg, DBP < 90 mmHg) 4. No history of chronic diseases, including cerebrovascular disease, cardiovascular disease, hypertension, kidney disease, liver disease, cancer, or diabetes mellitus 5. Not pregnant or lactating, and confirmed non-pregnant by a negative urine pregnancy test 6. No history of substance use or drug abuse 7. No depressive symptoms based on the two-question depression screening test 8. Normal cognitive function assessed by the Mini-Mental State Examination 9. Normal vision and hearing 10. Able to read and write in Thai

Exclusion criteria

Exclusion criteria: 1. History of central nervous system or psychiatric disorders 2. Communication, visual, or hearing impairments that interfere with testing 3. Cognitive or perceptual disturbances, such as disorientation or poor cooperation 4. Family history of hereditary neurological or psychiatric diseases 5. History of allergy or hypersensitivity to any components of the investigational product, including curcumin, turmeric (powder or fresh), or other curcumin-containing plants such as galangal and fingerroot; gamma oryzanol, rice bran oil, rice germ, or brown rice; and lactose, cow milk, or other dairy-derived products 6. Individuals with contraindications such as renal impairment, biliary or gallbladder disease, gastrointestinal disorders, hypothyroidism, or pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Blood chemistry, Liver function, Kidney function, Vitamin B12 levels, C-Reactive Protein Blood, liver and kidney functions, Vitamin B12, and C-reactive protein were assessed at baseline and after 8 weeks of intervention. Automated Hematology Analyzer, Automated clinical chemistry analyzer, Immunoassay

Secondary

MeasureTime frame
Executive function scores At baseline, 4 weeks, and 8 weeks after the start of the intervention. Wisconsin card sorting test, Cognitive battery task

Countries

Thailand

Contacts

Public ContactSutisa Thanoi

Naresuan University

sutisat@nu.ac.th055964784

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026