The effects of Hibiscus sabdariffa L calyces aqueous extract on insulin resistance in metabolic syndrome volunteers

Phase 2

Completed

• Conditions: metabolic syndrome; metabolic syndrome, metabolic diseases, glucose metabolism disorders, insulin resistance, hyperinsulinism, hypertension, pathologic processes

• Registration Number: TCTR20221102001
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-02
• Study Completion: 2024-02-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)