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.
Humans
Adolescent
Young Adult
Adult
Middle Aged
PPAR alpha
/ genetics
Diet, Reducing
Butyric Acid
/ therapeutic use
Glucagon-Like Peptide 1
/ therapeutic use
Uncoupling Protein 1
/ genetics
Transcription Factors
Obesity
/ diagnosis
Dietary Supplements
/ adverse effects
Randomized Controlled Trials as Topic
Appetite
Energy metabolism genes
Obesity
Randomized controlled trial
Sodium butyrate
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
01 Aug 2023
01 Aug 2023
Historique:
received:
06
11
2021
accepted:
03
11
2022
medline:
3
8
2023
pubmed:
2
8
2023
entrez:
1
8
2023
Statut:
epublish
Résumé
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. 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. 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. Iranian Registry of Clinical Trials: IRCT20190303042905N2 . Registered on 31 January 2021.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
Iranian Registry of Clinical Trials: IRCT20190303042905N2 . Registered on 31 January 2021.
Identifiants
pubmed: 37528450
doi: 10.1186/s13063-022-06891-9
pii: 10.1186/s13063-022-06891-9
pmc: PMC10392013
doi:
Substances chimiques
PPAR alpha
0
Butyric Acid
107-92-6
Glucagon-Like Peptide 1
89750-14-1
Uncoupling Protein 1
0
Transcription Factors
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
489Informations de copyright
© 2023. The Author(s).
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