The effects of melatonin and branched-chain amino acids supplementation in cardiac cachexia

The effects of melatonin and branched-chain amino acids (BCAA) supplementation, separately and together on inflammatory factors, muscle wasting, nutritional status and quality of life in cachectic heart failure patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121028011288N14

Enrollment

Registered

2018-02-01

Start date

2018-01-21

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Cardiac cachexia. Heart failure

Interventions

Intervention 1: Intervention group 1: Melatonin 20 mg/day (one tablet containing 20 mg melatonin/day) for 8 weeks. Intervention 2: Intervention group 2: Branch chain amino acids (BCAA) 10 g/day (five

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with chronic heart failure Ages between 30-70 years old Weight loss = 7.5% in last 6 months (or more) or BMI less than 20 kg/m2 (In cases where weight loss cannot be documents)

Exclusion criteria

Exclusion criteria: Patients with diabetes, chronic renal failure and dialysis needed, respiratory failure or any other chronic disease Taking immunosuppressive, anti inflammatory drugs and corticosteroids, vitamin, antioxidant or any other nutritional supplements in last 6 months

Design outcomes

Primary

Measure	Time frame
Serum level of Tumor necrosis factor-a (TNF- a). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum Level of Interleukin 6 (IL-6). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of high sensitivity C-reactive protein (hsCRP). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of Albumin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: enzymatic kit.;Serum level of Lactate dehydrogenase. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of creatine phosphokinase. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: enzymatic kit.;Serum level of myostatin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of total cholesterol (TC). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of High-density lipoprotein cholesterol (HDL-c). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of triglycerides. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of Low-density lipoprotein cholesterol (LDL-c). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Friedewald formula.;Body fat free mass (FFM). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Bioelectrical impedance analysis.;Body fat mass (FM). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Bioelectrical impedance analysis.;Resting energy expenditure (REE). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Indirect calorimetry.;Appetite. Timepoint: At the beginning of the st	—

Measure

Time frame

Serum level of Tumor necrosis factor-a (TNF- a). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum Level of Interleukin 6 (IL-6). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of high sensitivity C-reactive protein (hsCRP). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of Albumin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: enzymatic kit.;Serum level of Lactate dehydrogenase. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of creatine phosphokinase. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: enzymatic kit.;Serum level of myostatin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of total cholesterol (TC). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of High-density lipoprotein cholesterol (HDL-c). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of triglycerides. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Enzymatic kit.;Serum level of Low-density lipoprotein cholesterol (LDL-c). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Friedewald formula.;Body fat free mass (FFM). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Bioelectrical impedance analysis.;Body fat mass (FM). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Bioelectrical impedance analysis.;Resting energy expenditure (REE). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Indirect calorimetry.;Appetite. Timepoint: At the beginning of the st

—

Secondary

Measure	Time frame
Energy intake level. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: 3-day Food Record Questionnaire.;Macronutrients intake level. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: 3-day Food Record Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Jafari

Tabriz University of Medical Sciences

hamedjafari65@gmail.com+98 41 3381 1902

Outcome results

None listed

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