Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

NCT ID: NCT04045392

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2021-08-31

Brief Summary

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.

Conditions

Breast Cancer; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mediterranean diet group

Mediterranean diet with calorie restriction below 1,500 kcal per day.

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: 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.

Conventional diet group

Conventional diet with calorie restriction below 1,500 kcal per day.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mediterranean diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Won Lee

Associate Professor, Department of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 35845810 (View on PubMed)

Other Identifiers

3-2019-0140

Identifier Type: -

Identifier Source: org_study_id