Diabetes, Metabolic Syndrome and Obesity (Sep 2020)
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
Abstract
A-Ra Cho,1 Won-Jun Choi,2 Yu-Jin Kwon,1 Hye Sun Lee,3 Sung Gwe Ahn,4 Ji-Won Lee5 1Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea; 2Department of Medicine, Graduate School, Yonsei University, Seoul 03722, Republic of Korea; 3Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; 4Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; 5Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of KoreaCorrespondence: Ji-Won Lee Department of Family MedicineGangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 06273, Republic of KoreaTel +82 2 2019 3482Email [email protected]: 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, naltrexone/bupropion, obesity, breast cancer survivors
