Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity

Summary

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.

Conditions

• Obesity
• Insulin Resistance

Interventions

DIETARY_SUPPLEMENT

Normoprotein diet with animal protein

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%).

DIETARY_SUPPLEMENT

Normoprotein diet with vegetable protein

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%).

DIETARY_SUPPLEMENT

High-protein diet with animal protein

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%).

DIETARY_SUPPLEMENT

High-protein diet with vegetable protein

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%).

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  lead OTHER

Principal Investigators

• Martha Guevara-Cruz, Dr · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-03

Primary Completion

2020-01-01

Completion

2020-01-01

Countries

• Mexico

Study Locations