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Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mediterranean Diet
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Diet therapy, Mediterranean diet, Oxidant Stress markers, Proinflammatory markers, Body Composition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years old,
  • BMI value to be ≥25 kg/m2,
  • To be diagnosed with breast cancer stage I, II or III,
  • Being a positive hormone receptor status, one of the biological subtypes of breast cancer,
  • Having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study,
  • Not applying any treatment for body weight loss,
  • Accepting to participate in the study,
  • Perceiving disorder and not having communication problems.

Exclusion Criteria:

  • Being under the age of 18 and over the age of 65,
  • BMI value to be 40 kg/m2,
  • Having advanced stage breast cancer (IV and V),
  • Being diagnosed with cancer or metastasis in other organs,
  • Being one of the biological subtypes of breast cancer, hormone receptor status being negative,
  • Using antioxidant vitamin-mineral supplements,
  • Using herbal supplements,
  • Being pregnant or planning a pregnancy,
  • To stop working after starting diet therapy.

Sites / Locations

  • Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediterranean Diet

Arm Description

In the study, the participants were applied a diet compatible with the Mediterranean diet for 8 weeks.

Outcomes

Primary Outcome Measures

Change in body weight
Body weight (kg) was measured using the InBody 270 brand device.
Change in body mass indexs
The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from mass in kilograms and height in metres.
Change in fat mass measured by bioelectrical impedance analyzer
Fat mass (kg) was measured using the InBody 270 brand device.
Change in fat-free mass measured by bioelectrical impedance analyzer
Fat-free mass (kg) was measured using the InBody 270 brand device.
Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer
RMR (kcal) was measured using the InBody 270 brand device.
Change in interleukin 6 (IL-6)
Blood was drawn from participants for assessment of IL-6 (pg/mL) at the beginning and end of the study after fasting for at least 8 hours
Change in tumor necrosis factor alpha (TNF-α)
Blood was drawn from participants for assessment of TNF-α (pg/mL) at the beginning and end of the study after fasting for at least 8 hours
Change in malondialdehyde (MDA)
Blood was drawn from participants for assessment of MDA (mmol/L) at the beginning and end of the study after fasting for at least 8 hours
Change in total antioxidant status (TAS)
Blood was drawn from participants for assessment of TAS (mmol/L) at the beginning and end of the study after fasting for at least 8 hours
Change in total oxidant status (TOS)
Blood was drawn from participants for assessment of TOS (µmol/L) at the beginning and end of the study after fasting for at least 8 hours

Secondary Outcome Measures

Change in waist circumference
Waist circumference (cm) was measured with a non-stretch tape measure.
Change in hip circumference
Hip circumference (cm) was measured with a non-stretch tape measure.
Change in dietary inflammatory index (DII)
Dietary inflammatory index (DII) was calculated with 3-day food consumption record.
Change in oxidative stress index (OSI)
The oxidative stress index (OSI) value expressed as a percentage of the ratio of serum total oxidant status (TOS) levels to total antioxidant status (TAS) levels was calculated.

Full Information

First Posted
March 23, 2021
Last Updated
March 25, 2021
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT04818996
Brief Title
Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients
Official Title
Evaluation of the Effect of Mediterranean Diet on Body Composition, Oxidant Stress and Proinflammatory Markers in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.
Detailed Description
Breast cancer is the most common type of cancer among women in both developed and developing countries and is the leading cause of cancer death among women worldwide. Breast cancer is a disease that can develop and progress for various reasons. In addition to unchangeable factors such as increasing age and genotype, modifiable factors such as smoking, alcohol consumption, lack of physical activity, malnutrition, and obesity play a role in the pathogenesis of the disease. Breast cancer risk increases with increasing body mass index (BMI) in postmenopausal women. Chronic inflammation in obesity is associated with an increase in the release of proinflammatory factors (such as TNF-α, IL-1, IL-6). This situation; It is a risk factor for many types of cancer such as colon, stomach, breast and prostate carcinomas and supports a cause-effect relationship between obesity and cancer. These proinflammatory factors act as signal converters for tumor growth and progression. Obese women have elevated levels of TNF-α and IL-6 in the circulation, and this is associated with the development and progression of breast tumors. The Mediterranean Diet, which consists of high amounts of monounsaturated fatty acids, fruits, vegetables and whole grains, has been widely evaluated and indicated as an important factor in preventing tumor formation from inflammatory pathways. Weight loss improves the antitumor immune system, lowers estrogen levels, reduces the risk of breast cancer and has been associated with better outcomes in obese patients. Lifestyle intervention studies strongly suggest that weight loss is possible and observational studies can actually improve breast cancer survival.In this regard, a healthy lifestyle and diet are the first steps to prevent breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Diet therapy, Mediterranean diet, Oxidant Stress markers, Proinflammatory markers, Body Composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
In the study, the participants were applied a diet compatible with the Mediterranean diet for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Diet
Intervention Description
While calculating the energy of the Mediterranean diet applied to the individuals participating in the study, Mifflin-St. Jeor equation is used. The macronutrient composition of the Mediterranean diet was calculated as 36-40% fat, 40-45% carbohydrate and 15-20% protein. This diet is enriched with natural foods (fruits, vegetables, legumes, whole grain foods, fish, olive oil and oilseeds such as walnuts and almonds). In addition, anthropometric measurements and body composition analysis of the participants were performed both at the beginning and at the end of the study, and some biochemical parameters (IL-6, TNF-α, CRP, MDA, TAS, TOS and routine blood parameters) were evaluated.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Body weight (kg) was measured using the InBody 270 brand device.
Time Frame
Baseline, 8 weeks
Title
Change in body mass indexs
Description
The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from mass in kilograms and height in metres.
Time Frame
Baseline, 8 weeks
Title
Change in fat mass measured by bioelectrical impedance analyzer
Description
Fat mass (kg) was measured using the InBody 270 brand device.
Time Frame
Baseline, 8 weeks
Title
Change in fat-free mass measured by bioelectrical impedance analyzer
Description
Fat-free mass (kg) was measured using the InBody 270 brand device.
Time Frame
Baseline, 8 weeks
Title
Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer
Description
RMR (kcal) was measured using the InBody 270 brand device.
Time Frame
Baseline, 8 weeks
Title
Change in interleukin 6 (IL-6)
Description
Blood was drawn from participants for assessment of IL-6 (pg/mL) at the beginning and end of the study after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in tumor necrosis factor alpha (TNF-α)
Description
Blood was drawn from participants for assessment of TNF-α (pg/mL) at the beginning and end of the study after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in malondialdehyde (MDA)
Description
Blood was drawn from participants for assessment of MDA (mmol/L) at the beginning and end of the study after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in total antioxidant status (TAS)
Description
Blood was drawn from participants for assessment of TAS (mmol/L) at the beginning and end of the study after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in total oxidant status (TOS)
Description
Blood was drawn from participants for assessment of TOS (µmol/L) at the beginning and end of the study after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
Waist circumference (cm) was measured with a non-stretch tape measure.
Time Frame
Baseline, 8 weeks
Title
Change in hip circumference
Description
Hip circumference (cm) was measured with a non-stretch tape measure.
Time Frame
Baseline, 8 weeks
Title
Change in dietary inflammatory index (DII)
Description
Dietary inflammatory index (DII) was calculated with 3-day food consumption record.
Time Frame
Baseline, 8 weeks
Title
Change in oxidative stress index (OSI)
Description
The oxidative stress index (OSI) value expressed as a percentage of the ratio of serum total oxidant status (TOS) levels to total antioxidant status (TAS) levels was calculated.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old, BMI value to be ≥25 kg/m2, To be diagnosed with breast cancer stage I, II or III, Being a positive hormone receptor status, one of the biological subtypes of breast cancer, Having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study, Not applying any treatment for body weight loss, Accepting to participate in the study, Perceiving disorder and not having communication problems. Exclusion Criteria: Being under the age of 18 and over the age of 65, BMI value to be 40 kg/m2, Having advanced stage breast cancer (IV and V), Being diagnosed with cancer or metastasis in other organs, Being one of the biological subtypes of breast cancer, hormone receptor status being negative, Using antioxidant vitamin-mineral supplements, Using herbal supplements, Being pregnant or planning a pregnancy, To stop working after starting diet therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Deniz Güneş
Organizational Affiliation
Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Official's Role
Study Chair
Facility Information:
Facility Name
Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
City
Aydın
State/Province
Efeler
ZIP/Postal Code
09100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Learn more about this trial

Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

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