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临床试验/NCT05136313
NCT05136313已完成不适用

Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating

Instituto de Nutrición y Tecnología de los Alimentos1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
TG

研究概览

简要总结

Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin resistance and altered endocrine function. However, not all obese people develop metabolic complications, which has given rise to the concept of "metabolically healthy obesity" (MHO). Recent evidence suggests that intermittent fasting methods, in particular time-restricted eating (TRE) may be effective in improving cardiometabolic health, independently of weight loss, and this could be particularly effective in MUO subjects. The investigators hypothesize that in young male adults TRE is a more effective/beneficial approach in MUO than in MHO due to the weight loss-independent improvement in their inflammatory and metabolic derangements. To this aim, a 16-week 8h TRE intervention study will be performed in MHO and MUO subjects, assessing anthropometric, endocrine, and other outcomes.

详细描述

Although clinical differences between metabolically healthy and unhealthy obesity (MHO and MUO, respectively) have been extensively described, cellular mechanisms involved in these different phenotypes are largely unknown. This evidence is crucial for proposing preventive and therapeutic approaches. Recently, intermittent fasting methods, in particular time-restricted eating (TRE, a self-selected daily limited eating window protocol), have shown to be effective in improving cardiometabolic health, independently of weight loss, which could be particularly relevant in MUO.

The investigators will recruit young (20-22y-old) males with obesity (Body Mass Index≥30) and classify them as MHO or MUO (≤1 or ≥3 metabolic syndrome risk factors, respectively). A 16-week, 8h TRE intervention will be conducted in MHO vs. MUO subgroups, to assess and compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood mononuclear cell (PBMC) mechanistic/signaling response.

The investigators expect to advance the understanding of cellular mechanisms implicated in MHO and MUO, including potential therapeutic targets. Ultimately, the investigators expect to find relevant opportunities for intervention to prevent the serious cardiometabolic consequences of obesity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Belong to the GOCS cohort at INTA
  • •Own and use a Smartphone with Apple iOS or Android OS
  • •Baseline eating period ≥ 13 h per day.

排除标准

  • •Medications for any metabolic syndrome disorder
  • •Shift workers
  • •Known inflammatory and/or rheumatologic disease
  • •History of cardiovascular event
  • •Thyroid or adrenal disease, malignancy or diabetes
  • •History of eating disorder.
  • •Special diet (e.g., celiac disease),or any other disease or treatment that may interfere with the study.

研究组 & 干预措施

MHO

Experimental

metabolically healthy obese subjects undergoing TRE

干预措施: Time-restricted eating (Behavioral)

MUO

Experimental

metabolically unhealthy obese subjects undergoing TRE

干预措施: Time-restricted eating (Behavioral)

结局指标

主要结局

TG

时间窗: 16 weeks

Fasting triglycerides

次要结局

  • Waist circumference(16 weeks)

研究者

发起方
Instituto de Nutrición y Tecnología de los Alimentos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Cifuentes

Professor

Instituto de Nutrición y Tecnología de los Alimentos

研究点 (1)

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