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Investigating the effect of lycopene in metabolic syndrome patients.

Extraction of lycopene from tomatoes and formulation of lycopene tablets and stability studies and investigation of its antioxidant effects clinically.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130507013263N3
Enrollment
90
Registered
2022-10-14
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: Intervention group: Daily intake of one pill containing 20 mg of antioxidant lycopene extracted from tomato paste and formulated in the first phase of this study for 60 days. each volu

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Living in Mashhad. Consent and expression of desire to participate in the plan. Having metabolic syndrome based on the IDF index, which is at least two parameters associated with waist circumference (having a waist circumference higher than 94 cm in men and 80 cm in women, having fasting blood sugar higher than 100 mg/dl or having diabetes, Having triglycerides higher than 150 mg/dl, having systolic blood pressure of 130 mm Hg or diastolic blood pressure higher than 85 mm Hg or using antihypertensive drugs, having HDL less than 40 mg/dl in men and less than 50 mg/dl in women). Men and women between the ages of 18-60 years.

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding. volunteers who have a history of taking complementary medicines in the last 6 months. volunteers with chronic heart diseases. Patients taking medications that may interact with lycopene.

Design outcomes

Primary

MeasureTime frame
Prooxidant-antioxidant balance in blood serum of volunteers. Timepoint: The beginning of the study (before the start of the intervention) and the end of the study (60 days later). Method of measurement: Using PAB kit and measurement in blood serum.;Measuring lipid profile in blood serum. Timepoint: The beginning of the study (before the start of the intervention) and the end of the study (60 days later). Method of measurement: Using a lipid profile assay kit and measuring the concentration of LDL, HDL, TG and total cholesterol in blood serum.;Examining the level of inflammatory and pro-inflammatory cytokines. Timepoint: The beginning of the study (before the start of the intervention) and the end of the study (60 days later). Method of measurement: Using ELISA kits to measure the level of cytokines IL-4, IL-6, IL-10, IFN?, MCP-1, TNFa in blood serum.;Anthropometric studies. Timepoint: at the beginning of the study (before the start of the intervention), in the middle of the study (30 days later) and at the end of the study (60 days later). Method of measurement: By using the InBody device and measuring parameters such as the percentage of body fat and muscle of the volunteers.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Mirahmadi

Mashhad University of Medical Sciences

miram951@mums.ac.ir+98 51 3766 6279

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026