Effects of Mediterranean diet based intervention in postmenopausal women with breast cancer receiving adjuvant hormone therapy

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0004333
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

This randomized controlled trial investigated the effects of a Mediterranean diet-based intervention on obesity and metabolic parameters in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy. A total of 78 participants were randomly assigned to the Mediterranean diet (MeDiet) group or control group, and we analyzed the changes in body composition and metabolic parameters after 8-week intervention. Body weight and fat mass were significantly decreased in the MeDiet group compared to the control group. Among metabolic parameters, only tirglycerides significantly decreased in the MeDiet group compared to the control group. Our findings suggest that the Mediterranean diet may help weight loss and improve metabolic parameters such as triglycerides in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-10
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

1) Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage ?-? and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy
2) Postmenopausal women
3) Body mass index (BMI) =23 kg/m2
4) Able to speak and read Korean
5) Able to comply with all required study procedures and schedule
6) Willing and able to give written informed consent

Exclusion Criteria

1) Participants with cancer recurrence or metastasis
2) Participants with weight change more than 5kg in the previous 3 months
3) Participants with secondary causes of obesity, such as uncontrolled hypothyroidism
4) Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
5) Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
6) Participants who are taking weight loss medications
7) Participants who are receiving systemic corticosteroid therapy
8) Participants who have food allergy (seafood, fish, nuts, eggs, meat, tomato, wheat, soybean)
9) Participants with alcohol abuse or dependence
10) Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in C-Reactive Protein (CRP) levels;Change in fasting insulin levels;Change in fasting glucose levels;Change in lipid profile

Secondary Outcome Measures

Name	Time	Method
Change in body weight;Change in fat mass measured by bioelectrical impedance analyzer