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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet group | Experimental | Mediterranean diet with calorie restriction below 1,500 kcal per day. |
|
| Conventional diet group | No Intervention | Conventional diet with calorie restriction below 1,500 kcal per day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | Two meals (breakfast and dinner) a day, five times a week, are delivered to participants' homes without charge. The meals are prepared, under the supervision of an expert nutritionist, by a chef trained on the principles of the Mediterranean diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-Reactive Protein (CRP) levels | Blood will be drawn from the participants for assessment of CRP levels (mg/L) | Baseline, 8 weeks |
| Change in fasting insulin levels | Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours | Baseline, 8 weeks |
| Change in fasting glucose levels | Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours | Baseline, 8 weeks |
| Change in lipid profile | 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 | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | We will measure body weight (kg) of participants using the same scale | Baseline, 8 weeks |
| Change in fat mass measured by bioelectrical impedance analyzer | We will measure fat mass (kg) using bioelectrical impedance analyzer |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35845810 | Derived | Cho AR, Hong KW, Kwon YJ, Choi JE, Lee HS, Kim HM, Bae SJ, Ahn SG, Jeong J, Lee JW. Effects of Single Nucleotide Polymorphisms and Mediterranean Diet in Overweight or Obese Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: A Pilot Randomized Controlled Trial. Front Nutr. 2022 Jul 1;9:882717. doi: 10.3389/fnut.2022.882717. eCollection 2022. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Baseline, 8 weeks |
| Change in quality of life assessed by EORTC QLQ-C30 questionnaire | Quality of life will be assessed by questionnaire, named European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), score range 0~100, higher scores indicate better quality of life | Baseline, 8 weeks |
| Change in quality of life assessed by OP scale questionnaire | Quality of life will be assessed by questionnaire, named Obesity-related problems scale (OP scale), scale range 0~100, higher scores indicate more problems | Baseline, 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |