Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease

Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with breast fibrocystic disease.

Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).

Among patients with fibrocystic breast disease referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. intervention period: 12 weeks

Inclusion criteria: Overweight or obese women aged 18-45 years and diagnosed with fibrocystic breast disease. Patients with moderate or severe cyclic mastalgia. Exclusion criteria: Malignant breast diseases, taking medicines for reducing pain (such as danazol, tamoxifen, bromocriptine) over the past three months, menopause women, pregnant or breastfeeding women, psychological diseases, the consumption of any herbal or chemical sedative or hormonal medicines during the study, unwillingness to cooperate.

Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks.

Outcomes: Breast Pain Severity and hs-CRP (primary outcomes) and biomarkers of oxidative stress, parameters of mental health, glucose metabolism indices (secondary outcomes) will be quantified at study baseline and end-of-trial

To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<30 and ≥30 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the general surgery clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded.