Obesity Clinical Trial
Official title:
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
NCT number | NCT03627104 |
Other study ID # | 2373 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 3, 2018 |
Est. completion date | January 1, 2020 |
Verified date | September 2018 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Adults (men and women) between the ages of 18 and 60. - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Martha Guevara Cruz | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resistance insulin | 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 | Baseline to 1-month | |
Secondary | Amino acid profile | Change in the concentration of the amino acid profile, mainly of branched chain amino acids | Baseline to 1-month | |
Secondary | Change in body composition | Change in fat mass, lean mass and skeletal muscle mass percentage | Baseline to 1-month | |
Secondary | Change in body weight | change in body weight before and after of dietary intervention | Baseline to 1-month | |
Secondary | Change in waist circumference | Change in waist circumference before and after of dietary intervention | Baseline to 1-month | |
Secondary | Change in grip strength | Change in grip strength before and after the intervention by dynamometry | Baseline to 1-month | |
Secondary | Change in respiratory quotient | The respiratory coefficient will be determined by indirect calorimetry | Baseline to 1-month | |
Secondary | Change in glucose serum | The concentration of serum glucose will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in total cholesterol serum | The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in HDL cholesterol serum | The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in triglycerides serum | The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in LDL cholesterol serum | The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in free fatty acids serum | The concentration of free fatty acids will be determined before and after the intervention | Baseline to 1-month | |
Secondary | Change liver function tests | The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in concentration of leptin serum | The concentration of serum leptin will be determined by ELISA kit before and after the intervention | Baseline to 1-month | |
Secondary | Change in concentration of adiponectin serum | The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention | Baseline to 1-month | |
Secondary | Change in the concentration of C-reactive protein | The concentration of serum C- reactive protein will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in systolic and diastolic blood pressure | the blod pressure will be determined before and after the intervention | Baseline to 1-month | |
Secondary | 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). | HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention | Baseline to 1- month |
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