Resveratrol Stimulates Insulin Sensitivity, and Changes Microbiota Taxonomy and Serum Metabolomics in Participants With Obesity and Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
There is evidence that resveratrol can improve insulin resistance in rodents and humans with obesity and it can also improve muscle mitochondrial content mediated through activation of AMPK. However, little is known if this improvement is associated with changes in the gut microbiota and how gut microbiota is associated with serum metabolites after consumption of resveratrol. In the present study, the investigators show that the consumption of resveratrol for 2 months could influence insulin sensitivity in subjects with obesity. This effect will be accompanied by a modification of the microbiota taxonomy and the metabolites derived from this. Consequently, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of mitochondrial biogenesis in skeletal muscle.
详细描述
The investigators included 38 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of HOMA-IR index greater than 2.5, and BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Participants who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with obesity. Participants were randomly distributed to consume a) placebo treatment or b) resveratrol capsules (150 mg/day). The participants were followed for 2 months. In the pre-randomization visit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile and serum insulin, blood pressure, body weight and height and body composition. The presence of insulin resistance was determined by means of the HOMA-IR index. For the first visit body composition, other biochemical parameters such as protein c reactive, alanine transaminase, aspartate transaminase, hemoglobin glycosylated, hormones as leptin and adiponectin, free fatty acids in serum, malondialdehyde in serum, lipopolysaccharide in serum, short chain fatty acids in feces, fecal microbiota and serum metabolomics were determined. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then protein extraction was performed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female.
- •Between 20 and 60 years
- •BMI ≥ 30 and ≤ 40 kg/m2
- •Presence of insulin resistance (HOMA-IR index ≥ 2.5)
- •Willing and able to sign written informed consent prior to trial entry
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 BUN> 20 mg / dL.
- •Patients with acquired diseases that produce obesity and diabetes secondarily.
- •Patients who have suffered a cardiovascular event.
- •Patients with gastrointestinal diseases.
- •Weight loss > 3 kg in the last 3 months.
- •Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- •Pregnancy status.
- •Antibiotic consumption 3 months prior to the study.
- •Be an undergraduate or graduate student within the Institute.
- •Positive smoking.
- •Drug treatment:
- •Antihypertensive drugs or treatment
- •Treatment with hypoglycemic agents or insulin and antidiabetic drugs.
- •Treatment with statins, fibrates or other drugs to control dyslipidemia.
- •Use of antibiotics in the three months prior to the study.
- •Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.
- •Anorexigenic or that accelerate weight loss such as sibutramine or orlistat.
- •Probiotic, prebiotic or symbiotic supplements.
研究组 & 干预措施
Placebo
Maltodextrin capsules, administered orally once every 12 hours
干预措施: Placebo (Dietary Supplement)
Resveratrol
Resveratrol capsules of 75 mg each, 150 mg/day
干预措施: Resveratrol (Dietary Supplement)
结局指标
主要结局
Insulin sensitivity
时间窗: Baseline to 2 months
Measurement of insulin by an oral glucose tolerance test.
次要结局
- Fecal microbiota(Baseline to 2 months)
- Antioxidant profile(Baseline to 2 months)
- Blood pressure(Baseline to 2 months)
- Body weight(Baseline to 2 months)
- HDL cholesterol(Baseline to 2 months)
- Glucose metabolism profile(Baseline to 2 months)
- Insulin (µUI/ml)(Baseline to 2 months)
- Triglycerides(Baseline to 2 months)
- Total cholesterol(Baseline to 2 months)
- LDL cholesterol(Baseline to 2 months)
- Change in AMPK content(Through study completion, an average of 2 months)
- Succinate dehydrogenase(Through study completion, an average of 2 months)
- Change in PGC1α content(Through study completion, an average of 2 months)