lipid profiles and hepatic steatosis in hyperlipidemia-obese humans Effect of Ocimum sanctum L. flower extract on lipid profiles and hepatic steatosis in hyperlipidemia-obese humans
Conditions
Interventions
This study investigated the efficacy of active compounds in holy basil flowers (gallic acid, eugenol, ursolic acid, and polyphenols) in reducing blood lipid levels and liver fat volume in obese indivi
Experimental Dietary Supplement,Placebo Comparator No treatment
Ocimum sanctum L. flower ,Control
Sponsors
Program Management Unit for Competitiveness (PMUC)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged 20 years or older. 2. Body Mass Index (BMI) Greater than or equal to 25 kg/m2. 3. Hyperlipidemia (LDL-C greater than or equal to 130 mg/dL). 4. Participants may or may not receive lipid-lowering medication, but if receiving medication, must take a fixed dose for at least 8 weeks. 5. If a female volunteer of reproductive age, she must be negative for pregnancy via urine test and will use contraception for the entire 25 weeks of the study, or be postmenopausal or have undergone sterilization. 6. Participants must be able to attend the study for the entire 7-month period. 7. Participants must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have any type of diabetes. 2. Have severe liver or kidney disease (GOT/GPT > 3 times the maximum value or total bilirubin/direct bilirubin greater than 2.0/1.0 mg/dL or eGFR < 45). 3. Have uncontrolled thyroid disease. 4. Have a history of organ transplantation. 5. Have immunodeficiency disorders, cancer, or be taking immunosuppressants such as cyclosporine, tacrolimus, azathioprine, and chemotherapeutic agents. 6. Are pregnant or breastfeeding. 7. Have taken medications that may increase blood sugar levels within 4 weeks prior to participation in the study, such as corticosteroids and immunosuppressive agents. 8. Have participated in other studies within 8 weeks prior to participation in this research project. 9. Have taken medications that may affect blood lipid levels, such as oral contraceptive pills, high-dose diuretics or beta-blockers, antiretroviral protease inhibitors, tegretol, and anabolic steroids, unless these medications have been taken continuously at a constant dose for at least [number] weeks. 8 weeks prior to joining the study. 10. Used weight-loss medication within 3 months prior to joining the research project. 11. History of allergy to basil. 12. Triglyceride levels exceeding 400 mg/dL. 13. Hospitalized for an acute illness within 2 months prior to joining the project. 14. Consume alcoholic beverages more than twice a week, with beer > 360 ml, spirits > 45 ml, wine > 150 ml in women, or beer > 720 ml, spirits > 90 ml, wine > 300 ml in men per serving. 15. Experience gastrointestinal symptoms including nausea, vomiting, anorexia, early satiety, diarrhea, or chronic constipation. 16. Individuals who did not sign informed consent forms to participate in the research project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of Ocimum sanctum L. flower extract on lipid profiles and hepatic steatosis in hyperlipidemia-obese humans week -1,week 0+-5 day,end of week 4+-5 day,end of week 12+-5 day,end of week 24+-5 day,end of week 26+-5 day Close out randomized study between a Basil flower extract and Placebo The packaging was labeled as A and B both the researchers and volunteers do not know which is A or B. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of Ocimum sanctum L. flower extract on lipid profiles and hepatic steatosis in hyperlipidemia-obese humans week -1,week 0+-5 day,end of week 4+-5 day,end of week 12+-5 day,end of week 24+-5 day,end of week 26+-5 day Close out randomized study between a Basil flower extract and Placebo The packaging was labeled as A and B both the researchers and volunteers do not know which is A or B. | — |
Countries
Thailand
Contacts
Public ContactSupawan Buranapin
Faculty of medicine, Chiang Mai University
Outcome results
None listed