Skip to main content
OpenTrials
Completed

NCT Number: NCT03627104

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martha Guevara Cruz

Mexico City, 14060, Mexico

About this study

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)

  • A clinical-nutritional history
  • The determination of anthropometric measurements such as weight, height and waist circumference and body composition by bioimpedance.
  • Resting energy expenditure will be determined by indirect calorimetry
  • A glucose tolerance curve will be performed for 2 hours to determine the area under the insulin and glucose curve and determination of the insulinemic and glycemic indexes.
  • A whole blood sample will be taken for the determination of the serum concentration of glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, c reactive protein (CRP), insulin, leptin, and plasma amino acid profile.
  • A sample will be taken to isolate leukocytes, for the determination of the expression of enzymes related to branched-chain amino acids in leukocytes (BCAT and BCKDH).
  • A fecal sample for gut microbiota analysis will be collected.
  • The physical activity questionnaire will be carried out (IPAQ long version). The patient will be advised not to change the level of habitual physical activity
  • Patients will start consuming the diet corresponding to their group. The different menus will be delivered and explained to the patients.
  • A food guide will be given so that they have food exchange options.
  • You will be taught to fill the feed log.
  • Patients will be cited within a week.

Visit two:

  • A 24-hour dietary record.
  • Food logs will be collected and new ones will be delivered.
  • They will be given and explained the corresponding treatment menus.
  • They will be summoned in a week.

Visit three:

  • A 24-hours dietary record
  • Food logs will be collected and new ones will be delivered.
  • They will be given and explained the corresponding treatment menus.
  • They will be summoned in a week.

Visit four:

a) Nutritional assessment

  • The determination of anthropometric measurements such as weight, waist circumference and body composition measurement will be made by means of bioimpedance.
  • The resting energy expenditure will be determined by indirect calorimetry.
  • A glucose tolerance curve will be carried out for 2 hours to determine the area under the insulin and glucose curve and determination of the insulinemic and glycemic indexes.
  • A whole blood sample will be taken to determine the serum concentration of glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, c-reactive protein (CRP), insulin, leptin, adiponectin and plasma amino acid profile.
  • A fecal sample for gut microbiota analysis will be collected.
  • There will be a 24-hour reminder.
  • The physical activity questionnaire will be carried out (IPAQ long version). The patient will be advised not to change the level of habitual physical activity.
  • Full feed logs will be collected.
  • It will be scheduled within fifteen days for delivery of results. Actions that will be carried out at the end of the study to maintain the continuity of the treatment

All patients after the end of the study, will be cited at 15 days where:

  • You will be given the results

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normoprotein diet with animal protein

Dietary Supplement

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%).

Normoprotein diet with vegetable protein

Dietary Supplement

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%).

High-protein diet with animal protein

Dietary Supplement

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%).

High-protein diet with vegetable protein

Dietary Supplement

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%).

Primary outcomes

  1. Resistance insulin

    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

Secondary outcomes

  1. Amino acid profile

    Time frame: Baseline to 1-month

    Change in the concentration of the amino acid profile, mainly of branched chain amino acids

  2. Change in body composition

    Time frame: Baseline to 1-month

    Change in fat mass, lean mass and skeletal muscle mass percentage

  3. Change in body weight

    Time frame: Baseline to 1-month

    change in body weight before and after of dietary intervention

  4. Change in waist circumference

    Time frame: Baseline to 1-month

    Change in waist circumference before and after of dietary intervention

  5. Change in grip strength

    Time frame: Baseline to 1-month

    Change in grip strength before and after the intervention by dynamometry

  6. Change in respiratory quotient

    Time frame: Baseline to 1-month

    The respiratory coefficient will be determined by indirect calorimetry

  7. Change in glucose serum

    Time frame: Baseline to 1-month

    The concentration of serum glucose will be determined by autoanalyzer before and after the intervention

  8. Change in total cholesterol serum

    Time frame: Baseline to 1-month

    The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention

  9. Change in HDL cholesterol serum

    Time frame: Baseline to 1-month

    The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention

  10. Change in triglycerides serum

    Time frame: Baseline to 1-month

    The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention

  11. Change in LDL cholesterol serum

    Time frame: Baseline to 1-month

    The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention

  12. Change in free fatty acids serum

    Time frame: Baseline to 1-month

    The concentration of free fatty acids will be determined before and after the intervention

  13. Change liver function tests

    Time frame: Baseline to 1-month

    The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention

  14. Change in concentration of leptin serum

    Time frame: Baseline to 1-month

    The concentration of serum leptin will be determined by ELISA kit before and after the intervention

  15. Change in concentration of adiponectin serum

    Time frame: Baseline to 1-month

    The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention

  16. Change in the concentration of C-reactive protein

    Time frame: Baseline to 1-month

    The concentration of serum C- reactive protein will be determined by autoanalyzer before and after the intervention

  17. Change in systolic and diastolic blood pressure

    Time frame: Baseline to 1-month

    the blod pressure will be determined before and after the intervention

  18. 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).

    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

  19. Gut microbiota alpha diversity (Shannon Index)

    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.

  20. Gut microbiota composition

    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.

  21. Serum lipopolysaccharide (LPS) concentration

    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.

  22. Predicted microbial metabolic pathways

    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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.