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

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Normoprotein diet with animal protein
Normoprotein diet with vegetable protein
High-protein diet with animal protein
High-protein diet with vegetable protein
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Martha Guevara Cruz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Normoprotein diet with animal protein

Normoprotein diet with vegetable protein

High-protein diet with animal protein

High-protein diet with vegetable protein

Arm Description

The patient will intake the diet assigned for a month

The patient will intake the diet assigned for a month

The patient will intake the diet assigned for a month

The patient will intake the diet assigned for a month

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amino acid profile
Change in the concentration of the amino acid profile, mainly of branched chain amino acids
Change in body composition
Change in fat mass, lean mass and skeletal muscle mass percentage
Change in body weight
change in body weight before and after of dietary intervention
Change in waist circumference
Change in waist circumference before and after of dietary intervention
Change in grip strength
Change in grip strength before and after the intervention by dynamometry
Change in respiratory quotient
The respiratory coefficient will be determined by indirect calorimetry
Change in glucose serum
The concentration of serum glucose will be determined by autoanalyzer before and after the intervention
Change in total cholesterol serum
The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention
Change in HDL cholesterol serum
The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention
Change in triglycerides serum
The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention
Change in LDL cholesterol serum
The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention
Change in free fatty acids serum
The concentration of free fatty acids will be determined before and after the intervention
Change liver function tests
The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention
Change in concentration of leptin serum
The concentration of serum leptin will be determined by ELISA kit before and after the intervention
Change in concentration of adiponectin serum
The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention
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
Change in systolic and diastolic blood pressure
the blod pressure will be determined before and after the intervention
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

Full Information

First Posted
August 8, 2018
Last Updated
January 27, 2020
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT03627104
Brief Title
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
Official Title
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. 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). 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. 7. A food guide will be given so that they have food exchange options. 8. You will be taught to fill the feed log. 9. 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. 6. There will be a 24-hour reminder. 7. 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. 8. Full feed logs will be collected. 9. 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: 1. You will be given the results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The groups will receive the treatment simultaneously
Masking
Outcomes Assessor
Masking Description
the person who will perform the statistical analysis will be blinded from the intervention group by assigning each patient
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normoprotein diet with animal protein
Arm Type
Other
Arm Description
The patient will intake the diet assigned for a month
Arm Title
Normoprotein diet with vegetable protein
Arm Type
Other
Arm Description
The patient will intake the diet assigned for a month
Arm Title
High-protein diet with animal protein
Arm Type
Other
Arm Description
The patient will intake the diet assigned for a month
Arm Title
High-protein diet with vegetable protein
Arm Type
Other
Arm Description
The patient will intake the diet assigned for a month
Intervention Type
Dietary Supplement
Intervention Name(s)
Normoprotein diet with animal protein
Intervention Description
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%).
Intervention Type
Dietary Supplement
Intervention Name(s)
Normoprotein diet with vegetable protein
Intervention Description
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%).
Intervention Type
Dietary Supplement
Intervention Name(s)
High-protein diet with animal protein
Intervention Description
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%).
Intervention Type
Dietary Supplement
Intervention Name(s)
High-protein diet with vegetable protein
Intervention Description
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 Outcome Measure Information:
Title
Resistance insulin
Description
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
Secondary Outcome Measure Information:
Title
Amino acid profile
Description
Change in the concentration of the amino acid profile, mainly of branched chain amino acids
Time Frame
Baseline to 1-month
Title
Change in body composition
Description
Change in fat mass, lean mass and skeletal muscle mass percentage
Time Frame
Baseline to 1-month
Title
Change in body weight
Description
change in body weight before and after of dietary intervention
Time Frame
Baseline to 1-month
Title
Change in waist circumference
Description
Change in waist circumference before and after of dietary intervention
Time Frame
Baseline to 1-month
Title
Change in grip strength
Description
Change in grip strength before and after the intervention by dynamometry
Time Frame
Baseline to 1-month
Title
Change in respiratory quotient
Description
The respiratory coefficient will be determined by indirect calorimetry
Time Frame
Baseline to 1-month
Title
Change in glucose serum
Description
The concentration of serum glucose will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in total cholesterol serum
Description
The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in HDL cholesterol serum
Description
The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in triglycerides serum
Description
The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in LDL cholesterol serum
Description
The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in free fatty acids serum
Description
The concentration of free fatty acids will be determined before and after the intervention
Time Frame
Baseline to 1-month
Title
Change liver function tests
Description
The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in concentration of leptin serum
Description
The concentration of serum leptin will be determined by ELISA kit before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in concentration of adiponectin serum
Description
The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in the concentration of C-reactive protein
Description
The concentration of serum C- reactive protein will be determined by autoanalyzer before and after the intervention
Time Frame
Baseline to 1-month
Title
Change in systolic and diastolic blood pressure
Description
the blod pressure will be determined before and after the intervention
Time Frame
Baseline to 1-month
Title
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).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Guevara-Cruz, Dr
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martha Guevara Cruz
City
Mexico City
ZIP/Postal Code
14060
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity

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