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 :
Completed
First Posted : August 13, 2018
Last Update Posted : January 29, 2020
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 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 |
Actual Study Start Date : | September 3, 2018 |
Actual Primary Completion Date : | January 1, 2020 |
Actual Study Completion Date : | January 1, 2020 |

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%). |
- 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
- 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

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

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
Mexico | |
Martha Guevara Cruz | |
Mexico City, Mexico, 14060 |
Principal Investigator: | Martha Guevara-Cruz, Dr | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Martha Guevara Cruz, MD and PhD., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
ClinicalTrials.gov Identifier: | NCT03627104 |
Other Study ID Numbers: |
2373 |
First Posted: | August 13, 2018 Key Record Dates |
Last Update Posted: | January 29, 2020 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Insulin Resistance Overnutrition Nutrition Disorders Overweight |
Body Weight Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |