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临床试验/NCT05210023
NCT05210023已完成不适用

Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity

Instituto Tecnológico y de Estudios Superiores de Occidente2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
2
主要终点
Lipid profile change

研究概览

简要总结

Obesity is defined as the accumulation of excessive fat, attributed to the maintenance of a positive energy imbalance between calorie intake and expenditure. Obesity contributes to the development of many comorbidities such as type 2 diabetes, cardiovascular diseases, hypertension, metabolic syndrome, and dyslipidemias, among others. Dyslipidemias indicate a high concentration of lipids in the blood. Dyslipidemias cause more than 4 million premature deaths per year.

The pathogenesis of obesity is complex as it involves environmental, sociocultural, physiological, medical, behavioral, genetic, epigenetic, and many other factors. On the other hand, the causes of dyslipidemias can be: genetic / hereditary (primary dyslipidemias) or an inadequate lifestyle (secondary dyslipidemias).

Sufficient evidence indicates that lifestyle, mainly diet, plays a decisive role in the development of diseases such as obesity and dyslipidemias, in addition to that, recent research shows the importance of individual genetic predisposition to suffer from diseases. Data based on genome-wide association studies suggest a genetic predisposition for obesity and dyslipidemias with identification of various genes and genetic variations associated with these conditions. In this sense, the postulates of nutrigenetics as applied science are emphasized, since it states that food components can act on the human genome, directly or indirectly, to alter the expression of genes and gene products; diet can potentially compensate or accentuate the effects of genetic polymorphisms; and the consequences of a certain diet depend on the balance of health and disease states and the genetic background of an individual.

Therefore, when advising a change in diet and lifestyle as prevention and as part of the treatment for obesity and dyslipidemias, it is considered that a nutrigenetic intervention, that is, the administration of a diet designed according to genotypic characteristics and personal phenotypic, will have a much greater positive impact on the health status of people with detected genetic variations that make them susceptible to these pathologies.

For this reason, the implementation of nutrigenetic interventions could be a timely and successful avant-garde treatment to mitigate various cardiometabolic diseases such as dyslipidemias and others that are highly prevalent worldwide.

详细描述

After the selection of the population, the patients undergo a molecular diagnosis: DNA will be extracted from peripheral blood with the High Pure PCR (Polymerase Chain Reaction) Template Preparation Kit (Roche). Then certain polymorphisms will be determined by allelic discrimination with TaqMan® probes with real-time PCR.

The polymorphisms under study will be the following:

ABCA1 (ATP-binding cassette transporter ABCA1) rs9282541 PPARG (Peroxisome Proliferator Activated Receptor Gamma) rs1801282 LIPC (hepatic lipase) rs1800588 CETP (Cholesteryl ester transfer protein) rs708272 LPL (Lipoprotein lipase) rs13702 FABP2 (fatty acid binding protein 2) rs1799883 APOA5 (Apolipoprotein A-V) rs662799 APOC3 (Apolipoprotein C-III) rs5128 APOA1 (Apolipoprotein A-I) rs670 APOE (Apolipoprotein E) rs429358 and rs7412

Patients will be randomized into two different treatment groups. Randomization will be stratified according to age, BMI and sex. The allocation ratio will be 1: 1 and parallel intervention.Then, trained nutritionists will deliver the intervention according to the patient group and they will be followed-up for 8 weeks, which includes 3 face-to-face evaluations (baseline, 1st month and final) and 5 remote consultations, via zoom, every 15 days

Interventions will be provided as follows:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • 18-50 years old
  • Mexican- Mexican ancestry (3 generations)
  • Live in Guadalajara, Jalisco or metropolitan area.
  • Being overweight or obese BMI 25> 40
  • Waist circumference:
  • Women> 80 cm, Men> 94 cm.
  • Availability to attend virtual nutritional consultations

排除标准

  • Not meeting the inclusion criteria.
  • Pregnancy or breastfeeding
  • Gastrointestinal disorders
  • Endocrinopathies
  • Cardiovascular events
  • Diagnosed psychiatric illnesses.
  • Diagnosed diabetes
  • Take lipid-lowering drugs
  • Autoimmune diseases.

结局指标

主要结局

Lipid profile change

时间窗: Baseline, week 4, week 8

Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.

次要结局

  • Change in blood pressure(Baseline, week 4, week 8)
  • Change in physical activity practice(Baseline, week 8)
  • Change in insulin level(Baseline, week 4, week 8)
  • Visceral fat index change(Baseline, week 4, week 8)
  • Interleukins levels(Baseline, week 4, week 8)
  • Anthropometric measurements change(Baseline, week 4, week 8)
  • tumor Necrosis factor- alfa (TNF-alfa)(Baseline, week 4, week 8)
  • Change in food intake(Baseline, Week 4, week 8)
  • Body Weight change(Baseline, week 4, week 8)
  • Body Mass Index (BMI) change(Baseline, week 4, week 8)
  • C-reactive protein (CRP)(Baseline, week 4, week 8)
  • Change in glucose(Baseline, week 4, week 8)
  • Adherence to nutritional intervention(Week 4, week 8)
  • Insulin Resistance (HOMA-IR)(Baseline, week 4, week 8)
  • Body composition change(Baseline, week 4, week 8)

研究者

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

研究点 (2)

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