Investigating the effect of Melatonin Supplementation in bariatric surgery

Investigating the Effects of Melatonin Supplementation on Liver Function, Sleep Quality, Glycemic Index, Lipid Profile, and Anthropometric Status Before, and at 3 and 6 Months Post-Surgery in Bariatric Patients: A Double-Blind Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200301046655N5

Enrollment

Registered

2025-05-10

Start date

2025-04-05

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Mini bypass surgery. Z98.84

Interventions

Intervention 1: Intervention group: They will receive melatonin supplement (Karen Company) at a dose of 10 mg per day for 90 days before surgery. Intervention 2: Control group: They will receive a pla

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Body mass index 40 to 50 Candidate for mini bypass surgery

Exclusion criteria

Exclusion criteria: Previous history of bariatric surgery Absence of renal impairment Absence of severe hepatic impairment Exclusion of Omega-3 and Antioxidant Supplements (Vitamin E, Vitamin C, Vitamin B6, Selenium, Zinc, and Beta-Carotene Separately) During the 3 Months Prior to Entry into the Study. Exclusion of Individuals Using Glucocorticoid Medications at Doses Above 5 mg, Antibiotics, Nifedipine, Fluvoxamine, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Warfarin, Sedatives, Antidepressants, Smoking Individuals with night-shift jobs

Design outcomes

Primary

Measure	Time frame
Muscle mass. Timepoint: Before surgery, 1, 3 and 6 months after surgery. Method of measurement: Bioimpedance analyzer.;Lean mass. Timepoint: Before surgery, 1, 3 and 6 months after surgery. Method of measurement: Bioimpedance analyzer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRazieh Khalooeifard

Tehran University of Medical Sciences

shkhalooei1367@gmail.com+98 21 6634 8500

Outcome results

None listed

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