Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

NCT04818996 | Completed

• 1 other identifier: 2019/044
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Diet therapy; Mediterranean diet; Oxidant Stress markers; Proinflammatory markers; Body Composition

Outcome Measures

Primary Outcomes (10)

• Change in body weight

  Body weight (kg) was measured using the InBody 270 brand device.

  Baseline, 8 weeks

• 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.

  Baseline, 8 weeks

• Change in fat mass measured by bioelectrical impedance analyzer

  Fat mass (kg) was measured using the InBody 270 brand device.

  Baseline, 8 weeks

• Change in fat-free mass measured by bioelectrical impedance analyzer

  Fat-free mass (kg) was measured using the InBody 270 brand device.

  Baseline, 8 weeks

• Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer

  RMR (kcal) was measured using the InBody 270 brand device.

  Baseline, 8 weeks

• 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

  Baseline, 8 weeks

• 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

  Baseline, 8 weeks

• 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

  Baseline, 8 weeks

• 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

  Baseline, 8 weeks

• 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

  Baseline, 8 weeks

Secondary Outcomes (4)

• Change in waist circumference

  Baseline, 8 weeks

• Change in hip circumference

  Baseline, 8 weeks

• Change in dietary inflammatory index (DII)

  Baseline, 8 weeks

• Change in oxidative stress index (OSI)

  Baseline, 8 weeks

Study Arms (1)

Mediterranean Diet

EXPERIMENTAL

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

Behavioral: Mediterranean Diet

Interventions

Mediterranean Diet BEHAVIORAL

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.

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

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

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Burcu Deniz Güneş

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: October 22, 2019
• Primary Completion: December 17, 2019
• Study Completion: January 20, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)