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Evaluation of safety and efficacy of healthy-jelly contening water extract of rosella and passion fruit in volunteers

Evaluation of safety and efficacy of healthy-jelly contening water extract of rosella and passion fruit in volunteers

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220326001
Enrollment
43
Registered
2022-03-26
Start date
2021-06-07
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

Preventive or screening RP jelly drink in healthy human volunteers with hyperlipidemia Hyperlipidemia, Oxidative stress, blood lipid profile, inflammation, Passiflora edulis, Hibiscus Sabdariffa

Interventions

Jelly drink containing polyphenols-rich roselle calyces extract and passion fruit juice plus pulp concentrate (RP jelly drink),jelly drink without polyphenols-rich roselle calyces extract and passion
Experimental Other,Experimental Other
RP jelly drink ,Placebo

Sponsors

Thailand Institute of Scientific and Technological Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Lipid 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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactJurairat Khongrum

Chiang Mai University

jurarat.kh@cmu.ac.th0846861986

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026