Evaluation of safety and efficacy of healthy-jelly contening water extract of rosella and passion fruit in volunteers
- Conditions
- Preventive or screening RP jelly drink in healthy human volunteers with hyperlipidemiaHyperlipidemia, Oxidative stress, blood lipid profile, inflammation, Passiflora edulis, Hibiscus Sabdariffa
- Registration Number
- TCTR20220326001
- Lead Sponsor
- Thailand Institute of Scientific and Technological Research
- Brief Summary
RP jelly drink significantly reduced the LDL-C, TG, TNF-alpha and MDA of the subject and enhanced HDL-C and GSH compared to the placebo group. Therefore RP jelly drink continue for two months significantly improved the lipid profile of the subjects with hyperlipidemia. These actions are possibly due to presence of above biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
All participants were required to be aged 35 to 60 years with moderate high levels of total cholesterol (more than 200 mg/dL) and/or triglycerides (more than 150 mg/dL) and/or LDL cholesterol (more than 100 mg/dL) and/or HDL cholesterol (less than 40 mg/dL), and could not be using lipid-lowering drugs
Body mass index more than 35 kg/m2, Smokers, Athletes with high physical activity more than 3,000 kcal/day), Diabetes, Multiple allergies, Gastrointestinal disease, Cancer, Central nervous system or Psychiatric disorders, Traumatic injury and having been treated with supplement or any other drugs which were potentially able to affect the lipid metabolism in the previous 14 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ipid profiles At baseline or before the intervention, at 4 and 8 weeks after the intervention. Blood samples were collected intravenously by a registered nurse and determined biochemical results including blood glucose, TG, TC, HDL-C and LDL-C.
- Secondary Outcome Measures
Name Time Method Oxidative Stress Status including Malondialdehyde and glutathione level At baseline or before the intervention, at 4 and 8 weeks after the intervention. Spectrophotometry with enzyme activity,Inflammation Parameters including interleukin 6, 10 and TNF alpha At baseline or before the intervention, at 4 and 8 weeks after the intervention. Enzyme linked immunosorbent assay kit ,A key chemokine of atherosclerotic lesion (MCP 1 expression) At baseline or before the intervention, at 4 and 8 weeks after the intervention Enzyme linked immunosorbent assay kit,Body mass index (BMI) At baseline or before the intervention, at 4 and 8 weeks after the intervention Electronic scale ,Blood pressure At baseline or before the intervention, at 4 and 8 weeks after the intervention. Omron blood pressure monitor