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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627104
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE September 3, 2018
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Resistance insulin control after 1-month intervention. [ Time Frame: Baseline to 1-month ]
Reduction of index HOMA-IR.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Amino acid profile [ Time Frame: Baseline to 1-month ]
    Change in the concentration of the amino acid profile, mainly of branched chain amino acids
  • Change in body composition [ Time Frame: Baseline to 1-month ]
    Change in fat mass, lean mass and skeletal muscle mass percentage
  • Change in body weight [ Time Frame: Baseline to 1-month ]
    change in body weight before and after of dietary intervention
  • Change in waist circumference [ Time Frame: Baseline to 1-month ]
    Change in waist circumference before and after of dietary intervention
  • Change in grip strength [ Time Frame: Baseline to 1-month ]
    Change in grip strength before and after the intervention by dynamometry
  • Change in respiratory quotient [ Time Frame: Baseline to 1-month ]
    The respiratory coefficient will be determined by indirect calorimetry
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change in systolic and diastolic blood pressure [ Time Frame: Baseline to 1-month ]
    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). [ 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
Official Title  ICMJE Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
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)

  1. Participants who meet the inclusion criteria will be selected. These will be captured through advertising.
  2. Participants will be informed of the characteristics of the study, the risks and the benefits expected after the dietary intervention.
  3. Anthropometric and body composition measurements will be made.
  4. History of food frequency
  5. 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.
  6. 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)

  1. A clinical-nutritional history
  2. The determination of anthropometric measurements such as weight, height and waist circumference and body composition by bioimpedance.
  3. Resting energy expenditure will be determined by indirect calorimetry
  4. 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.
  5. 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.
  6. 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).
  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. 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:

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

Visit three:

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

Visit four:

a) Nutritional assessment

  1. The determination of anthropometric measurements such as weight, waist circumference and body composition measurement will be made by means of bioimpedance.
  2. The resting energy expenditure will be determined by indirect calorimetry.
  3. 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.
  4. 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The groups will receive the treatment simultaneously
Masking: Single (Outcomes Assessor)
Masking Description:
the person who will perform the statistical analysis will be blinded from the intervention group by assigning each patient
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • 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%).
Study Arms  ICMJE
  • Normoprotein diet with animal protein
    The patient will intake the diet assigned for a month
    Intervention: Dietary Supplement: Normoprotein diet with animal protein
  • Normoprotein diet with vegetable protein
    The patient will intake the diet assigned for a month
    Intervention: Dietary Supplement: Normoprotein diet with vegetable protein
  • High-protein diet with animal protein
    The patient will intake the diet assigned for a month
    Intervention: Dietary Supplement: High-protein diet with animal protein
  • High-protein diet with vegetable protein
    The patient will intake the diet assigned for a month
    Intervention: Dietary Supplement: High-protein diet with vegetable protein
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2020)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
96
Actual Study Completion Date  ICMJE January 1, 2020
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627104
Other Study ID Numbers  ICMJE 2373
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Sponsor  ICMJE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martha Guevara-Cruz, Dr Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
PRS Account Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP