metabolic syndrome metabolic syndrome, metabolic diseases, glucose metabolism disorders, insulin resistance, hyperinsulinism, hypertension, pathologic processes
Conditions
Interventions
Hibiscus sabdariffa L calyces aqueous extract (HS extract)- 125 mg in each tablet. Subject will be instructed to take four (4) tablets by mouth twice per day after breakfast and dinner for 12 weeks. ,
Experimental Drug,Placebo Comparator Other
Hibiscus sabdariffa L calyces aqueous extract ,Placebo
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Individuals with metabolic syndrome diagnosed by the presence of central obesity (waist circumference greater than 90 cm (men) or greater than 80 cm (women)) and two of the following criteria: (1) fasting triglyceride (TG) level greater than or equal to 150 mg/dl (2) fasting high-density lipoprotein (HDL) cholesterol level 0 - 40 mg/dl (men) or 0 - 50 mg/dl (women) (3) systolic blood pressure greater than or equal to 130 mm Hg or diastolic blood pressure greater than or equal to 85 mm Hg (4) fasting blood glucose 100 - 125 mg/dl 2. Non-smoker or quit smoking more than 6 months 3. Willing to stop taking dietary supplements which affected study outcomes for 4 weeks prior to study entry 4. Individuals who were agreeing to participate in the study and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known allergy to Hibiscus sabdariffa 2. Consumption of anthocyanin-rich sources during the study (blueberries, strawberries, bilberries, cranberries, elderberries, raspberries, mulberries, grapes, purple sweet potato, red cabbage, eggplant, red radish, pomegranate, rice berry, purple corn, and wine) more than 3 times per week 3. Alcohol consumption of more than 1 standard drink per day or more than 7 standard drinks per week (woman) and more than 2 standard drinks per day or more than 14 standard drinks per week (man) 4. Individuals with hypertension who are receiving hydrochlorothiazide, losartan, captopril, and amlodipine 5. Individuals with dyslipidemia who are receiving statin (simvastatin) 6. Individuals who are taking chloroquine 7. Individuals with SARS-CoV-2 infection 8. Individuals diagnosed with cardiovascular disease, type I and type II diabetes mellitus, and gout 9. Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or alkaline phosphatase (ALP) were out of normal range or suffering from hepatic diseases 10. Levels of creatinine and/or blood urea nitrogen (BUN) were out of normal range or suffering from kidney disease 11. History of cancer 12. Women who are pregnant, breast feeding, or planning to become pregnant during the trial, or positive in urine pregnancy test 13. Participation in other clinical research trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin resistance at baseline (week 0), week 6 and week 12 Change in insulin resistance between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12 (calculation of insulin resistance using HOMA-IR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting blood sugar at baseline (week 0), week 6 and week 12 Change in fasting blood sugar between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in glycated hemoglobin (HbA1c) at baseline (week 0) and week 12 Change in HbA1c between HS extract and placebo from baseline to week 12,Change in HDL-cholesterol at baseline (week 0), week 6 and week 12 Change in HDL-cholesterol between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in LDL-cholesterol at baseline (week 0), week 6 and week 12 Change in LDL-cholesterol between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in triglyceride at baseline (week 0), week 6 and week 12 Change in triglyceride between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in total cholesterol at baseline (week 0), week 6 and week 12 Change in total cholesterol between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in C-Reactive Protein (CRP) at baseline (week 0), week 6 and week 12 Change in CRP between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in interleukin-6 (IL-6) at baseline (week 0), week 6 and week 12 Change in IL-6 between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in tumor necrosis factor alpha (TNF-alpha) at baseline (week 0), week 6 and week 12 Change in TNF-alpha between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in waist circumference at baseline (0 week), 6 week, 12 week Change in waist circumference between HS extract and placebo from baseline to week 6, baseline to week 12, week 6 to week 12,Change in alanine aminotransferase (ALT) at baseline (week 0), week 6 and week 12 Change in ALT between HS extract and placebo from | — |
Countries
Thailand
Contacts
Public ContactWiroj Jiamjarasrangsi
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed