Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Resistance insulin
研究概览
简要总结
The prevention of obesity and its main medical complications, such as hypertension, type 2 diabetes and cardiovascular diseases, have been become a health priority. One of the most frequent metabolic complications in obesity is the insulin resistance and is the most important risk factor for the development of coronary diseases. The weight loss induced by the restriction of dietary energy is the cornerstone of therapy for people with obesity, as it improves or even regularizes insulin sensitivity and related comorbidities. However, weight loss induced by diet also decreases lean tissue mass, which could result in adverse effects on physical function. Although, regularly recommended to increase protein intake during weight loss, there is evidence to suggest that high protein intake could have deleterious metabolic effects. On the other hand, there is an association between the type of protein consumption, mainly the concentration of branched-chain amino acids (BCAAs) and insulin resistance during the dietary energy restriction in the therapy of obesity. There are multiple factors that influence the concentration of BCAAs and insulin resistance, which can be by phenotypic or genetic modification. The phenotypic modification refers to race, sex and dietary pattern. Meanwhile, the genetic modification refers to the activity of the enzymes responsible for the catabolism of BCAAs and genetic variants, such as the polymorphisms of a single nucleotide of said enzymes. A randomized controlled trial will be conducted with 160 participants (80 women and 80 men) divided by a draw in 4 groups, each for 20 participants. A feeding plan will be assigned according to the distribution of proteins (standard or high) and type of protein (animal or vegetable). The main aim of this study is to evaluate the effect on the amount and type of dietary protein and energy restriction on insulin resistance in subjects with obesity in a period of 1 month, considering the main factors that influence the concentration of BCAAs. In this way, evidence will be provided on what type of dietary intervention is most convenient for weight loss in subjects with insulin resistance and obesity.
详细描述
STUDY PROGRAM The study will consist of a previous examination and 4 visits during the follow-up period.
Previous visit: pre-admission (Duration approximately 40 minutes)
- Participants who meet the inclusion criteria will be selected. These will be captured through advertising.
- Participants will be informed of the characteristics of the study, the risks and the benefits expected after the dietary intervention.
- Anthropometric and body composition measurements will be made.
- History of food frequency
- A blood sample will be taken for the determination of glucose, insulin, total cholesterol, HDL cholesterol, LDL cholesterol, creatinine, and urea nitrogen (BUN) in serum. A fecal sample for gut microbiota analysis will be collected.
- The consent letter will be signed by the participants. Subsequently according to the previous visit if insulin resistance is diagnosed according to the HOMA index (IR-HOMA), The patient will be included in the visit one of the research protocol.
Visit one:
a) Nutritional assessment (Ambulatory Patient Unit)
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 who will perform the statistical analysis will be blinded from the intervention group by assigning each patient
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
- •Adults (men and women) between the ages of 18 and
- •Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - IR Index ≥ 2.5).
- •Mexican mestizos (parents and grandparents born in Mexico).
- •Patients who can read and write.
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 weight loss > 3 kg in the last 3 months.
- •Patients with any catabolic diseases.
- •Gravidity status
- •Positive smoking
- •Treatment with any medication
研究组 & 干预措施
Normoprotein diet with animal protein
The patient will intake the diet assigned for a month
干预措施: Normoprotein diet with animal protein (Dietary Supplement)
Normoprotein diet with vegetable protein
The patient will intake the diet assigned for a month
干预措施: Normoprotein diet with vegetable protein (Dietary Supplement)
High-protein diet with animal protein
The patient will intake the diet assigned for a month
干预措施: High-protein diet with animal protein (Dietary Supplement)
High-protein diet with vegetable protein
The patient will intake the diet assigned for a month
干预措施: High-protein diet with vegetable protein (Dietary Supplement)
结局指标
主要结局
Resistance insulin
时间窗: Baseline to 1-month
Change in the index HOMA-IR. The HOMA IR index will be calculated by the following equation: glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention
次要结局
- Change in free fatty acids serum(Baseline to 1-month)
- Change liver function tests(Baseline to 1-month)
- Change in concentration of adiponectin serum(Baseline to 1-month)
- Change of the HOMA index according to the presence or absence of polymorphism related to the metabolism of branched chain amino acids (rs11548193 and rs45500792).(Baseline to 1- month)
- Change in the concentration of C-reactive protein(Baseline to 1-month)
- Change in systolic and diastolic blood pressure(Baseline to 1-month)
- Amino acid profile(Baseline to 1-month)
- Change in waist circumference(Baseline to 1-month)
- Change in respiratory quotient(Baseline to 1-month)
- Change in total cholesterol serum(Baseline to 1-month)
- Change in triglycerides serum(Baseline to 1-month)
- Change in body composition(Baseline to 1-month)
- Change in body weight(Baseline to 1-month)
- Change in grip strength(Baseline to 1-month)
- Change in glucose serum(Baseline to 1-month)
- Change in HDL cholesterol serum(Baseline to 1-month)
- Change in LDL cholesterol serum(Baseline to 1-month)
- Change in concentration of leptin serum(Baseline to 1-month)
- Gut microbiota alpha diversity (Shannon Index)(Baseline to 1 month)
- Gut microbiota composition(Baseline to 1 month)
- Serum lipopolysaccharide (LPS) concentration(Baseline to 1 month)
- Predicted microbial metabolic pathways(Baseline to 1 month)
研究者
Martha Guevara Cruz
MD and PhD.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran