Martha Guevara Cruz
Mexico City, 14060, Mexico
NCT Number: NCT03627104
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.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Mexico City, 14060, Mexico
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)
Visit one:
a) Nutritional assessment (Ambulatory Patient Unit)
Visit two:
Visit three:
Visit four:
a) Nutritional assessment
All patients after the end of the study, will be cited at 15 days where:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
ach patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
Time frame: 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
Time frame: Baseline to 1-month
Change in the concentration of the amino acid profile, mainly of branched chain amino acids
Time frame: Baseline to 1-month
Change in fat mass, lean mass and skeletal muscle mass percentage
Time frame: Baseline to 1-month
change in body weight before and after of dietary intervention
Time frame: Baseline to 1-month
Change in waist circumference before and after of dietary intervention
Time frame: Baseline to 1-month
Change in grip strength before and after the intervention by dynamometry
Time frame: Baseline to 1-month
The respiratory coefficient will be determined by indirect calorimetry
Time frame: Baseline to 1-month
The concentration of serum glucose will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of free fatty acids will be determined before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum leptin will be determined by ELISA kit before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention
Time frame: Baseline to 1-month
The concentration of serum C- reactive protein will be determined by autoanalyzer before and after the intervention
Time frame: Baseline to 1-month
the blod pressure will be determined before and after the intervention
Time frame: Baseline to 1- month
HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention
Time frame: Baseline to 1 month
Change in gut microbial alpha diversity measured by the Shannon diversity index. The Shannon index will be calculated to assess changes in microbial richness and evenness following consumption of hypocaloric, high-protein diets with either animal- or plant-protein predominance.
Time frame: Baseline to 1 month
Change in gut microbial taxonomic composition at the phylum and genus levels determined by 16 svedberg ribosomal ribonucleic acid gene sequencing of fecal samples collected before and after the dietary intervention.
Time frame: Baseline to 1 month
Change in fasting serum lipopolysaccharide (LPS) concentrations measured before and after the dietary intervention as a marker of metabolic endotoxemia.
Time frame: Baseline to 1 month
Change in predicted microbial metabolic pathways inferred from 16 svedberg ribosomal ribonucleic acid gene sequencing data using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States analysis.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
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