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IRCT20161022030424N12 IRCT 2025-06-07 Tabriz University of Medical Sciences Effect of a modified Mediterranean diet (ModiMed) combined with Pomegranate seed oil in post-menopause breast cancer survivors Studying the effect of a modified Mediterranean diet (ModiMed) combined with Pomegranate seed oil (punicic acid) supplementation on bone health and metabolic profile in post-menopause overweight and obese breast cancer survivors 2025-07-21 anticipated 120 Complete https://irct.ir/trial/82790 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use a stratified block randomization method for allocation. The computer-generated code generated using SAS software version 8.01 will be used to create a randomized sequence by a statistician outside the project's research team. Randomization will be stratified based on age and body mass index. Serially numbered opaque sealed packets will be used to ensure allocation, Blinding description: Blinding the patients is not feasible in this trial. A trained nutritionist will ban diet-related conversations between assessors and patients during the study. Outcome assessors and the person responsible for statistical analysis will be blinded to the type of interventions received until the end of the study. 3 Treated breast cancer survivors. Intervention 1: Intervention group: Modified Mediterranean diet with Pomega 5 soft capsules from Vesha Daru Pars Herbal Pharmaceutical Company containing 500 mg of pomegranate seed oil (at least 10% panisic acid) for 6 weeks (The modified Mediterranean dietary intervention is a multi-variate intervention aimed at achieving low carbohydrate and low saturated fat intake, along with moderate protein and total fat intake. Consumption of extra-virgin olive oil, fish, raw and unsalted nuts (such as hazelnuts, almonds, walnuts, and pistachios), and non-starchy vegetables is unlimited.). Intervention 2: Intervention group: Modified Mediterranean diet with, Pomega 5 soft capsule placebo ,Vesha Daru Pars Herbal Pharmaceutical Company, for 6 weeks. Intervention 3: Intervention group: Pomega 5 soft capsules from Vesha Daru Pars Herbal Pharmaceutical Company contain 500 mg of pomegranate seed oil (at least 10% panisic acid) along with the American Cancer Society (ACS; high fiber, low fat) diet for 6 weeks. Intervention 4: Control group: American Cancer Society diet with Pomega 5 soft capsules placebo, Vesha Daru Pars Herbal Pharmaceutical Company, for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Neda Dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Less than 6 months after chemotherapy or radiation therapy of breast cancer (stage 0-IIIa) Cessation of menstruation for 12 months or more in the absence of specific causes other than natural menopause Body mass index of 25 kg/m2 and above Completion of all cancer-related treatments 40 years no limit Female Being on medically prescribed diets Planning on starting or stopping any chronic supplements or medications within six weeks before or throughout the study C50.9 Breast, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Modified Mediterranean diet with Pomega 5 soft capsules from Vesha Daru Pars Herbal Pharmaceutical Company containing 500 mg of pomegranate seed oil (at least 10% panisic acid) for 6 weeks (The modified Mediterranean dietary intervention is a multi-variate intervention aimed at achieving low carbohydrate and low saturated fat intake, along with moderate protein and total fat intake. Consumption of extra-virgin olive oil, fish, raw and unsalted nuts (such as hazelnuts, almonds, walnuts, and pistachios), and non-starchy vegetables is unlimited.) Intervention group: Modified Mediterranean diet with, Pomega 5 soft capsule placebo ,Vesha Daru Pars Herbal Pharmaceutical Company, for 6 weeks Intervention group: Pomega 5 soft capsules from Vesha Daru Pars Herbal Pharmaceutical Company contain 500 mg of pomegranate seed oil (at least 10% panisic acid) along with the American Cancer Society (ACS; high fiber, low fat) diet for 6 weeks. Control group: American Cancer Society diet with Pomega 5 soft capsules placebo, Vesha Daru Pars Herbal Pharmaceutical Company, for 6 weeks Weight. Timepoint: Weight measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Seca digital scale. Body mass index. Timepoint: Estimated body mass index at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Calculation. Body fat mass. Timepoint: Body fat mass measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Body composition analysis device. Lean body mass. Timepoint: Lean body mass measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Body composition analysis device. Quality of life. Timepoint: Quality of life measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: functional assessment of cancer therapy-breast cancer (FACT-B). Cancer-related fatigue. Timepoint: Cancer-related fatigue measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Brief Fatigue Inventory. Serum estradiol level. Timepoint: Serum estradiol level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum testosterone level. Timepoint: Serum testosterone level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum osteocalcin level. Timepoint: Serum osteocalcin level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum bone-specific alkaline phosphatase level. Timepoint: Serum bone-specific alkaline phosphatase level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum adiponectin level. Timepoint: Serum adiponectin level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum leptin level. Timepoint: Serum leptin level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum resistin level. Timepoint: Serum resistin level measurement at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Tabriz University of Medical Sciences Approved 2025-02-15 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)