Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 主要终点
- Change in C-Reactive Protein (CRP) levels
研究概览
简要总结
The purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage Ⅰ-Ⅲ and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy
- •Postmenopausal women
- •Body mass index (BMI) ≥23 kg/m2
- •Able to speak and read Korean
- •Able to comply with all required study procedures and schedule
- •Willing and able to give written informed consent
排除标准
- •Participants with cancer recurrence or metastasis
- •Participants with weight change more than 5kg in the previous 3 months
- •Participants with secondary causes of obesity, such as hypothyroidism
- •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)
- •Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
- •Participants who are taking weight loss medications
- •Participants who are receiving systemic corticosteroid therapy
- •Participants with alcohol abuse or dependence
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
研究组 & 干预措施
Mediterranean diet group
Mediterranean diet with calorie restriction below 1,500 kcal per day.
干预措施: Mediterranean diet (Behavioral)
Conventional diet group
Conventional diet with calorie restriction below 1,500 kcal per day.
结局指标
主要结局
Change in C-Reactive Protein (CRP) levels
时间窗: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Change in fasting insulin levels
时间窗: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours
Change in fasting glucose levels
时间窗: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours
Change in lipid profile
时间窗: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol (mg/dL) after fasting for at least 8 hours
次要结局
- Change in body weight(Baseline, 8 weeks)
- Change in fat mass measured by bioelectrical impedance analyzer(Baseline, 8 weeks)
- Change in quality of life assessed by EORTC QLQ-C30 questionnaire(Baseline, 8 weeks)
- Change in quality of life assessed by OP scale questionnaire(Baseline, 8 weeks)
研究者
Ji-Won Lee
Associate Professor, Department of Family Medicine
Gangnam Severance Hospital