The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial
Abstract Background Obesity is a multifaceted disease characterized by an abnormal accumulation of adipose tissue. Growing evidence has proposed microbiota-derived metabolites as a potential factor in the pathophysiology of obesity and related metabolic conditions over the last decade. As one of the...
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BMC
2023-08-01
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Online Access: | https://doi.org/10.1186/s13063-022-06891-9 |
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author | Parichehr Amiri Seyed Ahmad Hosseini Neda Roshanravan Maryam Saghafi-Asl Mitra Tootoonchian |
author_facet | Parichehr Amiri Seyed Ahmad Hosseini Neda Roshanravan Maryam Saghafi-Asl Mitra Tootoonchian |
author_sort | Parichehr Amiri |
collection | DOAJ |
description | Abstract Background Obesity is a multifaceted disease characterized by an abnormal accumulation of adipose tissue. Growing evidence has proposed microbiota-derived metabolites as a potential factor in the pathophysiology of obesity and related metabolic conditions over the last decade. As one of the essential metabolites, butyrate affects several host cellular mechanisms related to appetite sensations and weight control. However, the effects of butyrate on obesity in humans have yet to be studied. Thus, the present study was aimed to evaluate the effects of sodium butyrate (SB) supplementation on the expression levels of peroxisome proliferator activated-receptor (PPAR) gamma coactivator-1α (PGC-1α), PPARα and uncoupling protein 1 (UCP1) genes, serum level of glucagon-like peptide (GLP1), and metabolic parameters, as well as anthropometric indices in obese individuals on a weight loss diet. Methods This triple-blind randomized controlled trial (RCT) will include 50 eligible obese subjects aged between 18 and 60 years. Participants will be randomly assigned into two groups: 8 weeks of SB (600 mg/day) + hypo-caloric diet or placebo (600 mg/day) + hypo-caloric diet. At weeks 0 and 8, distinct objectives will be pursued: (1) PGC-1α, PPARα, and UCP1 genes expression will be evaluated by real-time polymerase chain reaction; (2) biochemical parameters will be assayed using enzymatic methods; and (3) insulin and GLP1 serum level will be assessed by enzyme-linked immunosorbent assay kit. Discussion New evidence from this trial may help fill the knowledge gap in this realm and facilitate multi-center clinical trials with a substantially larger sample size. Trial registration Iranian Registry of Clinical Trials: IRCT20190303042905N2 . Registered on 31 January 2021. |
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language | English |
last_indexed | 2024-03-12T17:05:53Z |
publishDate | 2023-08-01 |
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spelling | doaj.art-43feb4d3018747bab5df1298a441d1d62023-08-06T11:24:16ZengBMCTrials1745-62152023-08-012411810.1186/s13063-022-06891-9The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trialParichehr Amiri0Seyed Ahmad Hosseini1Neda Roshanravan2Maryam Saghafi-Asl3Mitra Tootoonchian4Student Research Committee, Ahvaz Jundishapur University of Medical SciencesNutrition and Metabolic Diseases Research Center, Clinical Research Institute, Ahvaz Jundishapur University of Medical SciencesCardiovascular Research Center, Tabriz University of Medical SciencesNutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical SciencesEndocrine Research Center, Tabriz University of Medical SciencesAbstract Background Obesity is a multifaceted disease characterized by an abnormal accumulation of adipose tissue. Growing evidence has proposed microbiota-derived metabolites as a potential factor in the pathophysiology of obesity and related metabolic conditions over the last decade. As one of the essential metabolites, butyrate affects several host cellular mechanisms related to appetite sensations and weight control. However, the effects of butyrate on obesity in humans have yet to be studied. Thus, the present study was aimed to evaluate the effects of sodium butyrate (SB) supplementation on the expression levels of peroxisome proliferator activated-receptor (PPAR) gamma coactivator-1α (PGC-1α), PPARα and uncoupling protein 1 (UCP1) genes, serum level of glucagon-like peptide (GLP1), and metabolic parameters, as well as anthropometric indices in obese individuals on a weight loss diet. Methods This triple-blind randomized controlled trial (RCT) will include 50 eligible obese subjects aged between 18 and 60 years. Participants will be randomly assigned into two groups: 8 weeks of SB (600 mg/day) + hypo-caloric diet or placebo (600 mg/day) + hypo-caloric diet. At weeks 0 and 8, distinct objectives will be pursued: (1) PGC-1α, PPARα, and UCP1 genes expression will be evaluated by real-time polymerase chain reaction; (2) biochemical parameters will be assayed using enzymatic methods; and (3) insulin and GLP1 serum level will be assessed by enzyme-linked immunosorbent assay kit. Discussion New evidence from this trial may help fill the knowledge gap in this realm and facilitate multi-center clinical trials with a substantially larger sample size. Trial registration Iranian Registry of Clinical Trials: IRCT20190303042905N2 . Registered on 31 January 2021.https://doi.org/10.1186/s13063-022-06891-9Sodium butyrateObesityEnergy metabolism genesAppetiteRandomized controlled trial |
spellingShingle | Parichehr Amiri Seyed Ahmad Hosseini Neda Roshanravan Maryam Saghafi-Asl Mitra Tootoonchian The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial Trials Sodium butyrate Obesity Energy metabolism genes Appetite Randomized controlled trial |
title | The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial |
title_full | The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial |
title_fullStr | The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial |
title_full_unstemmed | The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial |
title_short | The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial |
title_sort | effects of sodium butyrate supplementation on the expression levels of pgc 1α pparα and ucp 1 genes serum level of glp 1 metabolic parameters and anthropometric indices in obese individuals on weight loss diet a study protocol for a triple blind randomized placebo controlled clinical trial |
topic | Sodium butyrate Obesity Energy metabolism genes Appetite Randomized controlled trial |
url | https://doi.org/10.1186/s13063-022-06891-9 |
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