Zohreh Karbaschian1, Zeinab Mokhtari2, Abdolreza Pazouki3,4, Ali Kabir3,4, Mahdi Hedayati5, Somayeh Soleymanzadeh Moghadam6, Parvin Mirmiran7, Azita Hekmatdoost8. 1. International Branch, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Minimally Invasive Surgery Division, Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Iran, Head, Center of Excellence for Minimally Invasive Surgery Training, Iran University of Medical Sciences, Tehran, Iran. 4. Center of Excellence of European Branch of International Federation for Surgery of Obesity, Tehran, Iran. 5. Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 6. Antimicrobial Resistance Research Center, Institute of Immunology and Infectious Disease, Iran University of Medical Sciences, Tehran, Iran. 7. Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mirmiran@endocrine.ac.ir. 8. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Azita.Hekmatdoost@cw.bc.ca.
Abstract
BACKGROUND: Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study. RESULTS: At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B12, folate, and homocysteine between groups at week 16 of the study. DISCUSSION: Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies. TRIAL REGISTRATION: This study has been registered at Clinicaltrial.gov with registration number NCT02708589.
RCT Entities:
BACKGROUND: Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial on morbid obesepatients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study. RESULTS: At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B12, folate, and homocysteine between groups at week 16 of the study. DISCUSSION: Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies. TRIAL REGISTRATION: This study has been registered at Clinicaltrial.gov with registration number NCT02708589.
Entities:
Keywords:
Clinical trial; Gastric surgery; Morbidity; OAGB-MGB; Obesity; One anastomosis gastric bypass- mini gastric bypass surgery; Probiotics
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