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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161022030424N12

Enrollment

120

Registered

2025-06-07

Start date

2025-07-21

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

Treated breast cancer survivors. Breast, unspecified

Interventions

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% p

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.

Eligibility

Sex/Gender

Female

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Being on medically prescribed diets Planning on starting or stopping any chronic supplements or medications within six weeks before or throughout the study

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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 measu	—

Measure

Time frame

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 measu

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3334 7054

Outcome results

None listed

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