Investigating the effect of intermittent fasting (time-restricted eating) with and without calorie restriction compared to calorie restriction on anthropometric parameters, depression score, and metabolic factors in patients with major depression disorder and obesity: a study protocol for a randomized controlled trial.

IF 2.1 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2026-06-27 DOI:10.1186/s13063-026-09860-8

Alireza Bagherzadeh-Karimi, Naimeh Mesri Alamdari, Leila Hosseini, Leila Maghsoumi-Norouzabad

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引用次数: 0

Abstract

Background: It is suggested that intermittent fasting, specifically time-restricted eating (TRE), may have potential impact on depression in obese patients with major depression disorder (MDD). This study will aim to evaluate the effects of TRE with and without calorie restriction, compared to the traditional calorie restriction in patients suffering from MDD and obesity.

Methods/design: This single-center, single-blinded, prospective, randomized trial will be conducted on 90 obese patients with major depression over 24 weeks. Participants were randomly divided into three groups in a 1:1:1 ratio. Group 1: recipients of TRE with 8-h food intake restriction (fixed 8-h time period), 2: recipients of TRE (fixed 8-h time period) and calorie restriction (75% of required calories), and 3: group receiving calorie restriction (75% of required calories).

Main outcomes measure(s): The primary objective is assessment of changes in depression severity scores, alongside secondary outcomes including changes in parameters such as body weight, body mass index (BMI), waist circumference, fat mass, fat-free mass, circadian rhythm score, quality of life, physical activity, and key metabolic factors such as fasting glucose levels, serum insulin, hemoglobin A1C, insulin resistance and sensitivity, lipid profile, and blood pressure.

Discussion: While calorie restriction can promote weight loss, its long-term adherence and mental health effects remain inconsistent. Emerging approaches like TRE have shown promise in improving body weight and metabolic parameters, but their impact on mental health is less understood. This study aims to fill this gap by comparing time-restricted eating with a fixed 8-h eating window plus and minus calorie restriction, against standard calorie restriction, in obese patients with major depressive disorder. The findings could have significant clinical implications for integrated management of obesity and depression.

Trial registration: Iran Clinical Trials Registry, IRCTID: ( https://irct.behdasht.gov.ir/IRCT20241029063543N1 ). Registered on 26-11-2024.

查看原文本刊更多论文

研究间歇性禁食（限时进食）对重度抑郁症和肥胖患者的人体测量参数、抑郁评分和代谢因素的影响，并与不限制卡路里的患者进行比较：一项随机对照试验的研究方案。

背景：提示间歇性禁食，特别是限时饮食（TRE）可能对肥胖合并重度抑郁症（MDD）患者的抑郁有潜在影响。本研究旨在评估与传统的卡路里限制相比，TRE在有和没有卡路里限制的情况下对重度抑郁症和肥胖患者的影响。方法/设计：这项单中心、单盲、前瞻性、随机试验将对90例重度抑郁症肥胖患者进行为期24周的研究。参与者按1:1:1的比例随机分为三组。第1组：TRE组，8小时食物摄入限制（固定8小时时间段）；第2组：TRE组（固定8小时时间段），热量限制（所需热量的75%）；第三组：接受热量限制（所需热量的75%）。主要结局指标：主要目的是评估抑郁严重程度评分的变化，以及次要结局，包括体重、体重指数（BMI）、腰围、脂肪量、无脂量、昼夜节律评分、生活质量、体力活动和关键代谢因素（如空腹血糖水平、血清胰岛素、血红蛋白A1C、胰岛素抵抗和敏感性、血脂和血压）等参数的变化。讨论：虽然热量限制可以促进减肥，但长期坚持它和心理健康的影响仍然不一致。像TRE这样的新兴方法在改善体重和代谢参数方面显示出了希望，但它们对心理健康的影响却鲜为人知。本研究旨在填补这一空白，通过比较患有重度抑郁症的肥胖患者的限时饮食与固定的8小时进食窗口加减卡路里限制，与标准卡路里限制进行比较。这一发现可能对肥胖和抑郁的综合管理具有重要的临床意义。试验注册：伊朗临床试验注册中心，IRCTID:（https://irct.behdasht.gov.ir/IRCT20241029063543N1）。注册日期：26-11-2024

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

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.