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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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ClinicalTrials.gov Identifier: NCT03627104
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Dietary Supplement: Normoprotein diet with animal protein Dietary Supplement: Normoprotein diet with vegetable protein Dietary Supplement: High-protein diet with animal protein Dietary Supplement: High-protein diet with vegetable protein Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
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
Official Title: Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
Estimated Study Start Date : September 3, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Proteins

Arm Intervention/treatment
Normoprotein diet with animal protein
The patient will intake the diet assigned for a month
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%).

Normoprotein diet with vegetable protein
The patient will intake the diet assigned for a month
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%).

High-protein diet with animal protein
The patient will intake the diet assigned for a month
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%).

High-protein diet with vegetable protein
The patient will intake the diet assigned for a month
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%).




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627104


Contacts
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Contact: Martha Guevara-Cruz, Dr 525554870900 ext 2802 marthaguevara8@yahoo.com.mx

Locations
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Mexico
Martha Guevara Cruz Recruiting
Mexico City, Mexico, 14060
Contact: Martha Guevara Cruz, Dr         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Martha Guevara-Cruz, Dr Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications:

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Responsible Party: Martha Guevara Cruz, MD and PhD., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03627104     History of Changes
Other Study ID Numbers: 2373
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases