The effects of time-restricted eating in comparison with energy-restricted diet on expression of BMAL-1 and miRNA-let-7f-1-3p genes, circadian rhythm status, sleep quality, metabolic and anthropometric markers in obese women: a study protocol for a randomized controlled clinical trial.
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引用次数: 0
Abstract
Introduction: One of the most common chronic diseases is obesity. Disturbances in circadian rhythm and sleep quality are common in these people. Genes related to circadian rhythm control are also disrupted. One of the methods of controlling and reducing obesity is to intervene in the individual's diet, and one of the alternative methods to the conventional low-calorie diet is the use of fasting diets, including time-restricted eating (TRE), which can have effects on the expression of a circadian rhythm genes, the circadian rhythm status, and the quality of sleep. This randomized controlled trial (RCT) will be aimed to examine the effect of the TRE diet in comparison with an energy-restricted diet (ERD) on the expression of basic helix-loop-helix ARNT-Like-1 (BMAL-1) and micro ribonucleic acid (miRNA)-let-7f-1-3p genes, circadian rhythm status, and sleep quality in women with obesity.
Methods and analysis: This study will be conducted on 42 obese women. Participants will be randomly assigned to receive either 16:8 TRE (fasting from 8 to 12 PM the next day) or an ERD (55% carbohydrate, 30% fat, 15% protein) diet for 12 weeks. Gene expression, circadian rhythm status, sleep quality, anthropometric measurements, and metabolic evaluations will be assessed before and after the intervention. Dietary evaluations will be performed at baseline, middle, and end of the study.
Discussion: Since circadian rhythm-related gene expression has a role in circadian rhythm and ultimately obesity regulation, it seems that TRE, as a dietary approach, can affect these gene expressions.
Trial registration: Iranian Registry of Clinical Trials (IRCT20100123003140N25), which was registered and approved on 28 July 2025 ( https://irct.behdasht.gov.ir/user/trial/84484/view ).
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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