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临床试验/NCT06710340
NCT06710340招募中不适用

Influence of Acute Nut Intake on the Effects of High Saturated Fat Meals in Obese Diabetic Women

Raquel Ballarin2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
2
主要终点
Oxidative stress assessment

研究概览

简要总结

Obesity is a multifactorial disease in which excess body fat accumulation increases the risk of other chronic diseases such as type 2 diabetes. The primary cause of obesity is the energy imbalance between calories consumed and expended. A balanced diet is essential for weight control and maintaining a healthy body weight. In this context, the intake of a high saturated fat meal (HSFM) plays a detrimental role, contributing to the development of obesity, type 2 diabetes, cancer, cardiovascular diseases, and exacerbating chronic inflammation. Additionally, it may induce metabolic endotoxemia and modulate profiles of circulating microRNAs. Therefore, due to the harmful health impacts of HSFM, studies on metabolomics and circulating microRNA levels could enhance understanding of the mechanisms of walnuts (Juglans regia) in the prevention and treatment of diseases. The aim of this study is to evaluate whether acute walnut supplementation attenuates the inflammatory response, oxidative stress, glycemic response, and regulates the metabolomic and circulating microRNA responses induced by HSFM in women with obesity and type 2 diabetes. The study will be randomized and crossover, including obese, non-insulin-dependent diabetic women aged over 18, without other comorbidities. In the first phase, participants will arrive at the clinic after a 10-hour fast and will be offered HSFM with or without 30g of walnuts. In the second phase, participants who did not receive walnuts will now receive them along with the HSFM and vice versa. Blood samples will be collected, and serum insulin, glucose, serum biomarkers of inflammation and oxidative stress will be evaluated. TNF-alpha, IL-6, IL-1β, IL-1ra, IL-8, and IL-10 will be measured by ELISA, and MDA by HPLC. Additionally, metabolomic and microRNA analyses will be conducted. Data analysis will be performed using JAMOVI v 2.3.21, with a significance level of 5%.

详细描述

Obesity is a multifactorial disease in which excess body fat accumulation leads to negative health effects. It is considered a global public health problem, primarily due to its association with an increased risk of developing other non-communicable chronic diseases (NCDs). In Brazil, it is estimated that one quarter of the population is obese, making it an important risk factor for pathological aging.

The primary cause of obesity is the energy imbalance between calories consumed and expended, and its high prevalence is associated with physical inactivity and sedentary behavior. A balanced diet, consisting of natural and minimally processed foods, is known to be essential for weight control. However, in the current scenario, there has been a significant increase in the consumption of ultra-processed foods and a decrease in the intake of natural and minimally processed foods, resulting in a major impact on the prevalence of obesity.

Obesity is one of the most relevant risk factors for type 2 diabetes, a disease that is increasingly prevalent worldwide and is considered one of the health emergencies of the 21st century. Diabetes impacts morbidity and mortality and is a major risk factor for stroke, kidney dysfunction, cardiovascular diseases, vision loss, and neuropathy. Non-pharmacological strategies to control diabetes typically include nutritional intervention, regular physical activity, smoking cessation, and maintenance of a healthy body weight.

Acute intake of macronutrients can induce adverse responses even in healthy individuals, which may lead to chronic effects over time. In this context, the intake of a high saturated fat meal (HSFM) plays an important role, as chronic consumption of a HSFM is known to contribute to the development of obesity, type 2 diabetes, cancer, and cardiovascular diseases, as well as exacerbate chronic inflammation induced by insulin resistance and excess weight. Additionally, studies show that HSFM can also induce metabolic endotoxemia and modulate profiles of circulating microRNAs. MicroRNAs are non-coding RNA molecules about 22 nucleotides long that regulate gene expression at the post-transcriptional level by degrading mRNA or inhibiting the translation of target genes. Thus, microRNAs may contribute to the adverse effects of HSFM.

Given the detrimental health impacts of HSFM, studies have been conducted with acute supplementation of foods with anti-inflammatory and antioxidant properties, such as orange juice and green tea, in order to minimize the negative effects of unhealthy diets. A study conducted by our research group showed that acute supplementation of green tea inhibited the expression of 62 microRNAs induced by HSFM intake. Bioinformatics analysis revealed that these microRNAs regulated genes associated with TGF-beta, CARM1, RSK, and BMP pathways. Identifying these miRNAs and their molecular pathways can enhance understanding of the benefits of dietary compounds in health and disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women over 18 years of age
  • Diagnosis of obesity (body mass index [BMI >30 kg/m²])
  • Diagnosis of non-insulin-dependent type II diabetes

排除标准

  • Use of dietary supplements or corticosteroid use in the last 3 months
  • Diagnosis of insulin dependent diabetes
  • Diagnosis of cancer
  • Diagnosis of heart failure
  • Diagnosis of kidney diseases
  • Diagnosis of liver diseases
  • Diagnosis of lung diseases
  • Diagnosis ofneurological diseases
  • Diagnosis of allergy to any component of the high saturated fat meal or walnuts

结局指标

主要结局

Oxidative stress assessment

时间窗: 6 weeks

The cytokines TNF-alpha, IL-6, IL-1β, IL-1ra, IL-8, and IL-10 will be measured by ELISA following the manufacturer's instructions for the kits in pg/mL.

Metabolomic profile assessment

时间窗: 6 weeks

Serum concentrations of malondialdehyde (MDA) will be measured by high-performance liquid chromatography (HPLC) based on the reaction with thiobarbituric acid in µmol/L.

次要结局

未报告次要终点

研究者

发起方
Raquel Ballarin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raquel Ballarin

Principal Investigator

UPECLIN HC FM Botucatu Unesp

研究点 (2)

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