跳至主要内容
临床试验/NCT06971666
NCT06971666尚未招募不适用

Relationship Between Dietary Inflammatory Potential, Markers of Inflammation, Microbiota and Risk of Anxiety and Depression in Young People With Obesity

Instituto Tecnológico y de Estudios Superiores de Occidente0 个研究点目标入组 170 人开始时间: 2025年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
170
主要终点
Dietary Assessment

研究概览

简要总结

The increase in adipose tissue in the young population is one of the most important and worrying public health problems because it persists in adulthood, constituting a risk factor for chronic degenerative diseases with social, economic, and environmental effects. The etiology of obesity is multifactorial and is associated with a low-intensity chronic inflammation process. Therefore, side effects of the digestive, nervous, endocrine, and immunological levels are closely related. Thus, understanding the impact of dietary components on the immune response and the pathophysiological complications of obesity will strengthen information on nutritional patterns with lower inflammatory implications.

详细描述

  1. Background

Obesity has become one of the most critical challenges in public health. It has become a global epidemic due to the exponential growth of obesity over the last 30 years, affecting developed and developing countries with a notable impact on the latter. In Mexico, the combined prevalence of overweight and obesity in adults is 75.2%, of which 36.9% correspond precisely to the prevalence of obesity.

This pathology has a multifactorial etiology, links lifestyle, environment, and genetics, and is modulated by multiple interactions between psychological, cultural, and physiological factors. The World Health Organization defines obesity as the abnormal or excessive accumulation of adipose tissue, which can harm health. This accumulation of triglycerides in the adipocyte alters the secretion of specific molecules of the immune system, which causes a cascade of inflammation mediated by the secretion of inflammatory molecules.

Likewise, it is observed that obese subjects present intestinal dysbiosis that leads to intestinal permeability that allows the passage of lipopolysaccharides from Gram-negative bacteria into the bloodstream. There, they are recognized as toxic agents by the immune system, and the secretion of inflammatory cytokines occurs. The immune response derived from increased adipose tissue and intestinal dysbiosis compromises different brain regions involved in regulating behavior, eating patterns, perception of satiety, and being involved in cognition and mood related to physical inactivity and more significant weight gain. The continuous circulation of inflammatory cytokines and their accumulation in organs, including the central nervous system, is a risk factor for altering neurotransmitters and signal transduction that could result in depression.

In addition to the above, a close relationship has been reported between diet and the regulation of the inflammatory response, so changes in the dietary patterns of the Mexican population could be directly related not only to the excessive accumulation of adipose tissue but also to the persistent inflammatory response in this pathology. The Dietary Inflammatory Potential (DIP) tool has been used to evaluate the inflammation caused by an individual's diet based on their dietary inflammatory index (DII). The DII allows us to associate foods and their nutrients with markers that show pro-inflammatory or anti-inflammatory processes.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both sexes with no gender exclusion
  • •Age between 18 and 24 years
  • •Body Mass Index (BMI) ≥ 30 kg/m²
  • •Signed informed consent

排除标准

  • •Pregnancy or expected pregnancy within the next month
  • •Women who are breastfeeding
  • •Diagnosed conditions such as: diabetes mellitus, hypertension, renal or hepatic insufficiency, infectious diseases, inflammatory diseases, or any neoplastic disease
  • •Conditions with dietary restrictions, such as celiac disease or history of gastric bypass surgery
  • •Active alcoholism with a daily intake exceeding 50 g/day
  • •Significant anticipated changes in diet or exercise within 15 days prior to the study's start
  • •History of drug or medication abuse
  • •Eating disorders
  • •Participation in any study involving investigational products within the 3 months prior to the start of the study
  • •Treatment with anti-inflammatory drugs, antibiotics, and/or antidepressants in the month prior to the study's start
  • •Consumption of nutraceuticals containing prebiotics, probiotics, or immunomodulators within 15 days prior to the study's start
  • •Individuals who choose to discontinue participation after the data collection process has started.
  • •Individuals who do not consent to the collection of any of the required samples (blood, diet, or stool) during the data collection phase.

结局指标

主要结局

Dietary Assessment

时间窗: 1.5 years

Dietary intake will be estimated from a validated semiquantitative food frequency questionnaire (FFQ) that represents food consumption for the last 12 months. For each item, regular portion size will be established, and then frequencies of consumption will be available, ranging from "never" to "6 or more times/day". Energy and nutrient intakes will be obtained by multiplying the frequency by the serving size from Mexican food composition.

Dietary Inflammatory Index, DII

时间窗: 1.5 years

For the Dietary Inflammatory index, 45 food parameters related (positively or negatively) to inflammatory markers such as IL beta, IL4, IL6, IL10, TNF alpha, and CRP will be used. The score for each dietary parameter will be multiplied by each participant's intake, resulting in a numerical score ranging from -8 to +8.

Dietary Inflammatory Potential, DIP

时间窗: 1.5 years

The DIP will be obtained by analyzing the Dietary assessment and the Dietary Inflammatory Index intake, which will then be converted to a percentile score of 2 and subtracted by 1. The percentile score will be multiplied by the inflammatory effect score. All food parameters sill be summed to create the score. The score will be in quartiles: Q1, highly anti-inflammatory, Q2, anti-inflammatory, Q3, inflammatory; and Q4, highly inflammatory

次要结局

  • Inflammatory markers(1.5 years)
  • C-reactive protein (CRP)(1.5 years)
  • Intestinal microbiota(1.5 years)
  • Bioelectrical Impedance Analysis (BIA)(1.5 years)
  • Height(1.5 years)
  • Body weight(1.5 years)
  • Body Mass Index (BMI)(1.5 years)
  • Dual-Energy X-Ray Absorptiometry (DXA)(1.5 years)
  • Anxiety(1.5 years)
  • Depression(1.5 years)
  • Movement behavior(1.5 years)
  • Food security(1.5 years)

研究者

发起方
Instituto Tecnológico y de Estudios Superiores de Occidente
申办方类型
Other
责任方
Sponsor

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