Effect of Dietary Protein on the Regulation of Exosome MicroRNA Expression in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change
研究概览
简要总结
miRNAs are small non-coding RNAs of approximately 22 nucleotides in length, which have the function of regulating gene expression at the post-transcriptional level through base complementation of protein-coding transcripts, this interaction leading to translational repression by destabilizing the messenger RNA. Evidence demonstrates an association between differences in miRNA expression and the development of various pathologies, including obesity, type 2 diabetes, cardiovascular disease, neurodegenerative disorders and cancer. Other factors that could also modulate miRNA expression include nutritional status, diet and even exercise. The aim of this study is to identify exosome microRNAs that modify their expression in plasma from patients with insulin resistance fed different dietary protein sources. A randomized controlled clinical trial will be performed where the selected participants will be assigned by lottery to a dietary intervention of usual diet with protein of plant or animal origin for 4 weeks. The study will consist of 3 visits where anthropometric parameters, body composition, systolic and diastolic blood pressure, dietary compliance through 24-hour recall and food logs, biochemical tests (insulin, glucose, triglycerides, total cholesterol, HDL, LDL), the relative expression of plasma exosome miRNAs and markers of oxidative stress will be evaluated. Participants will receive a weekly food pantry during the first two visits in order to improve compliance to the dietary intervention.
详细描述
The study will evaluate the effect of 2 dietary interventions on the regulation of plasma exosome microRNA expression in patients with insulin resistance.
STUDY PROGRAM
The study will consist of 3 visits
Planned (selection of participants)
- Participants will be invited through advertisements.
- Participants will be corroborated to ensure that they meet the criteria for selection.
- If they are candidates for the protocol, participants will be provided with the letter of consent to read carefully and any doubts that may arise will be resolved. Participants will be informed about the characteristics of the study as well as the expected risks and benefits. If they agree, the participant will be asked to sign the consent form.
- Anthropometric measurements such as weight, height, blood pressure and body composition will be determined by means of bioelectrical impedance.
- A 24-hour reminder of food consumption will be made.
- A whole blood sample will be taken for glucose and insulin determination, in order to determine the HOMA-Insulin Resistance index.
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 (Outcomes Assessor)
盲法说明
The person performing the analysis of the study results should be unaware of the assigned intervention so that such knowledge does not influence the results. Therefore, it will be a person outside the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (men and women) between the ages of 18 and
- •Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - Insulin Resistance Index ≥ 2.5).
- •Signature of letter of consent
排除标准
- •Patients with any type of diabetes.
- •Patients with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen > 20 mg / dL.
- •Patients with acquired diseases that produce obesity and diabetes secondarily.
- •Patients who have suffered a cardiovascular event.
- •Patients with weight loss > 3 kg in the last 3 months.
- •Patients with any catabolic diseases.
- •Gravidity status
- •Positive smoking and alcoholism
- •Treatment with any medication
结局指标
主要结局
Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change
时间窗: 4 weeks
Fold change in the expression profile of microRNAs from exosomes after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) with real -time quantitative polymerase chain reaction
次要结局
- Change in the blood pressure in mmHg(4 weeks)
- Change in biochemical parameters in mg/dL(4 weeks)
- Change in the area under curve of insulin in microIU/mL per 2 hours(4 weeks)
- Change in the waist circumference in centimeters(4 weeks)
- Change in the Malondialdehyde in micromol/L(4 weeks)
- Change on HOMA index(4 weeks)
- Change in body weight in kg(4 weeks)
- Change in C Reactive Protein in mg/L(4 weeks)
- Amino acid profile in mmol/L(4 weeks)
- Change in the area under curve of glucose in mg/dL per 2 hours(4 weeks)
- Change in body composition in percentage(4 weeks)
研究者
Martha Guevara Cruz
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran