Effects of saffron extract and its two main carotenoids (crocin, crocetin) on coronary heart disease

Effects of saffron aqueous extract and its main carotenoids (crocin and crocetin) on expression of some genes involved in atherosclorosis in peripheral blood mononuclear cells of patients with coronary heart disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201512102017N26

Enrollment

Registered

2016-01-17

Start date

2016-01-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Coronary Heart Disease. Atherosclerotic heart disease

Interventions

Intervention 1: crocin capsule, 15 mg, twice daily. Intervention 2: saffron aqueous extract capsule, 15 mg, twice daily. Intervention 3: crocetin capsule, 5 mg, twice daily. Intervention 4: placebo, t

Treatment - Other

Placebo

crocin capsule, 15 mg, twice daily

saffron aqueous extract capsule, 15 mg, twice daily

crocetin capsule, 5 mg, twice daily

placebo, twice daily

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: overweight and obese patients with coronary heart disease; lack of cancers; autoimmune diseases and infectious; lack of allergy; no history of antioxidant supplements during the past six months; willingness to participate in this research project Exclusion criteria: Any MI; Catching any infectious disease during the study; Menopause; pregnancy and lactation; expose with any side effects during the study; Unwillingness to continue participation in the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sirtuin-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;AMPK expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;NF-kappa B expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;MCP-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;Plasma levels of MCP-1. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: elisa (ng/ml).;Lipid profile variables. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of TC, LDL-c, HDL-c, TG by autoanalyzer.	—

Measure

Time frame

Sirtuin-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;AMPK expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;NF-kappa B expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;MCP-1 expression. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: real time-PCR.;Plasma levels of MCP-1. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: elisa (ng/ml).;Lipid profile variables. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of TC, LDL-c, HDL-c, TG by autoanalyzer.

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Secondary

Measure	Time frame
Quality of life score. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: Mac new quality of life questionnaire.;Food intake. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: three days food records.;Appetite levels. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: visual analouge scale.;Anthropometric indices. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of height, waist and hip circumference with tape measure , weight with Seca scale.	—

Measure

Time frame

Quality of life score. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: Mac new quality of life questionnaire.;Food intake. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: three days food records.;Appetite levels. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: visual analouge scale.;Anthropometric indices. Timepoint: at baseline and after 2 months at the end of study. Method of measurement: measurements of height, waist and hip circumference with tape measure , weight with Seca scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Abedimanesh

Tabriz University of Medical Sciences

abedimaneshn@tbzmed.ac.ir+98 41 3335 7584

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026