Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial

A-Ra Cho; Won-Jun Choi; Yu-Jin Kwon; Hye Sun Lee; Sung Gwe Ahn; Ji-Won Lee

doi:10.2147/DMSO.S269237

Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial

Diabetes Metab Syndr Obes. 2020 Sep 29:13:3325-3335. doi: 10.2147/DMSO.S269237. eCollection 2020.

Authors

A-Ra Cho¹, Won-Jun Choi², Yu-Jin Kwon¹, Hye Sun Lee³, Sung Gwe Ahn⁴, Ji-Won Lee⁵

Affiliations

¹ Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea.
² Department of Medicine, Graduate School, Yonsei University, Seoul 03722, Republic of Korea.
³ Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.
⁴ Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.
⁵ Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.

Abstract

Introduction: The objective of this pilot randomized controlled trial was to investigate the combined effect of a Mediterranean diet and naltrexone/bupropion treatment on body weight, metabolic parameters, and quality of life in overweight or obese breast cancer survivors.

Methods: Forty-four breast cancer survivors were randomly assigned to receive the Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group). Twenty-eight age-matched non-cancer patients were instructed to consume the Mediterranean diet plus naltrexone/bupropion medication (non-cancer MeDiet+NB group). After the 8-week intervention, changes in body weight, metabolic parameters, nutrient intake, and quality of life of the three groups were assessed.

Results: Significant weight loss of 2.8 kg was noted for the breast cancer survivor MeDiet+NB group, 1.8 kg for the breast cancer survivor MeDiet-only group, and 2.5 kg for the non-cancer MeDiet+NB group after 8 weeks (P < 0.05 versus baseline by Wilcoxon's signed-rank test). All three groups also exhibited significantly lower fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels (P < 0.05). Quality of life as assessed by self-reported questionnaires showed improvement in all participants (P < 0.05). However, there were no significant differences of changes in body weights, metabolic parameters, and quality of life among the three groups or between the MeDiet+NB and MeDiet-only groups.

Conclusion: We found that the Mediterranean diet, with or without naltrexone/bupropion treatment, facilitates weight loss, improves metabolic parameters, and increases quality of life. The combination of the Mediterranean diet with naltrexone/bupropion treatment did not produce superior changes when compared to the Mediterranean diet alone.

Trial registration: This trial was retrospectively registered on 10 July 2018 as NCT03581630 at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03581630).

Keywords: Mediterranean diet; breast cancer survivors; naltrexone/bupropion; obesity.

Associated data

ClinicalTrials.gov/NCT03581630

Grants and funding

This research was supported by the Bio & Medical Technology Development Program, through the National Research Foundation of Korea funded by the Ministry of Science and ICT (NRF-2013M3A9B6046416, NRF-2018R1D1A1B07049223). This work was supported by the Technology Innovation Program (20002781, A Platform for Prediction and Management of Health Risk Based on Personal Big Data and Lifelogging) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea).