Effect of supplementation in treatment of Coronary Heart Disease

Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017051333941N1

Enrollment

Registered

2017-06-06

Start date

2017-05-18

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

Coronary Heart Disease. Chronic ischaemic heart disease, unspecified

Interventions

Intervention 1: Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo capsul

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Subjects aged 50-85 years; diagnosed with type 2 diabetes, CHD and overweight.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Consuming melatonin supplements within the last 3 months Having an acute myocardial infarction and cardiac surgery within the past 3 months The night shift workers

Design outcomes

Primary

Measure	Time frame
Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Protein carbonyl. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Protein carbonyl. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

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Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Systolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Diastolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Systolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Diastolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 8, 2026