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AzTrials

ObesityNCT03627104

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

A study testing Normoprotein diet with animal protein, Normoprotein diet with vegetable protein and High-protein diet with animal protein in people with Obesity and Insulin Resistance, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Obesity, Insulin Resistance
What is being tested?
Normoprotein diet with animal protein, Normoprotein diet with vegetable protein and High-protein diet with animal protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteMexico
Study dates
3 Sep 2018to 1 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Gravidity status
  • Positive smoking
  • Treatment with any medication

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Martha Guevara Cruz

    Mexico City, 14060

Other trials in Mexico

About this study

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.

Read the 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. A fecal sample for gut microbiota analysis will be collected.
  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:

  1. Nutritional assessment (Ambulatory Patient Unit)
  2. A clinical-nutritional history
  3. The determination of anthropometric measurements such as weight, height and waist circumference and body composition by bioimpedance.
  4. Resting energy expenditure will be determined by indirect calorimetry
  5. 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.
  6. 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.
  7. 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).
  8. A fecal sample for gut microbiota analysis will be collected.
  9. 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
  10. Patients will start consuming the diet corresponding to their group. The different menus will be delivered and explained to the patients.
  11. A food guide will be given so that they have food exchange options.
  12. You will be taught to fill the feed log.
  13. 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:

  1. Nutritional assessment
  2. The determination of anthropometric measurements such as weight, waist circumference and body composition measurement will be made by means of bioimpedance.
  3. The resting energy expenditure will be determined by indirect calorimetry.
  4. 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.
  5. 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. A fecal sample for gut microbiota analysis will be collected.
  7. There will be a 24-hour reminder.
  8. 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.
  9. Full feed logs will be collected.
  10. 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
Being tested
Normoprotein diet with animal protein, Normoprotein diet with vegetable protein, High-protein diet with animal protein, High-protein diet with vegetable protein
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normoprotein diet with animal proteinDietary 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 proteinDietary 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 proteinDietary 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 proteinDietary 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%).

Study groups in NCT03627104
Study groupRoleWhat they receive
Normoprotein diet with animal proteinOtherThe patient will intake the diet assigned for a month
Receives: Dietary Supplement: Normoprotein diet with animal protein
Normoprotein diet with vegetable proteinOtherThe patient will intake the diet assigned for a month
Receives: Dietary Supplement: Normoprotein diet with vegetable protein
High-protein diet with animal proteinOtherThe patient will intake the diet assigned for a month
Receives: Dietary Supplement: High-protein diet with animal protein
High-protein diet with vegetable proteinOtherThe patient will intake the diet assigned for a month
Receives: Dietary Supplement: High-protein diet with vegetable protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 1-month

Secondary outcomes (22)

  1. Amino acid profile

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

    Measured: Baseline to 1-month

  2. Change in body composition

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

    Measured: Baseline to 1-month

  3. Change in body weight

    change in body weight before and after of dietary intervention

    Measured: Baseline to 1-month

  4. Change in waist circumference

    Change in waist circumference before and after of dietary intervention

    Measured: Baseline to 1-month

  5. Change in grip strength

    Change in grip strength before and after the intervention by dynamometry

    Measured: Baseline to 1-month

  6. Change in respiratory quotient

    The respiratory coefficient will be determined by indirect calorimetry

    Measured: Baseline to 1-month

  7. Change in glucose serum

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

    Measured: Baseline to 1-month

  8. Change in total cholesterol serum

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

    Measured: Baseline to 1-month

  9. Change in HDL cholesterol serum

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

    Measured: Baseline to 1-month

  10. Change in triglycerides serum

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

    Measured: Baseline to 1-month

  11. Change in LDL cholesterol serum

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

    Measured: Baseline to 1-month

  12. Change in free fatty acids serum

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

    Measured: Baseline to 1-month

  13. Change liver function tests

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

    Measured: Baseline to 1-month

  14. Change in concentration of leptin serum

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

    Measured: Baseline to 1-month

  15. Change in concentration of adiponectin serum

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

    Measured: Baseline to 1-month

  16. 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

    Measured: Baseline to 1-month

  17. Change in systolic and diastolic blood pressure

    the blod pressure will be determined before and after the intervention

    Measured: Baseline to 1-month

  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).

    HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention

    Measured: Baseline to 1- month

  19. Gut microbiota alpha diversity (Shannon Index)

    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.

    Measured: Baseline to 1 month

  20. Gut microbiota composition

    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.

    Measured: Baseline to 1 month

  21. Serum lipopolysaccharide (LPS) concentration

    Change in fasting serum lipopolysaccharide (LPS) concentrations measured before and after the dietary intervention as a marker of metabolic endotoxemia.

    Measured: Baseline to 1 month

  22. Predicted microbial metabolic pathways

    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.

    Measured: Baseline to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start3 Sep 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The groups will receive the treatment simultaneously
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03627104
Sponsor's protocol ID
2373
Status last verified
Jul 2026
First submitted
8 Aug 2018
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available.

    PubMed 27974040

  • Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

    PubMed 23985870

  • Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.

    PubMed 27409811

  • David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

    PubMed 24336217

  • Kirk EP, Klein S. Pathogenesis and pathophysiology of the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2009 Dec;11(12):761-5. doi: 10.1111/j.1559-4572.2009.00054.x.

    PubMed 20021538

  • Klein S. Outcome success in obesity. Obes Res. 2001 Nov;9 Suppl 4:354S-358S. doi: 10.1038/oby.2001.142.

    PubMed 11707565

  • Wycherley TP, Moran LJ, Clifton PM, Noakes M, Brinkworth GD. Effects of energy-restricted high-protein, low-fat compared with standard-protein, low-fat diets: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2012 Dec;96(6):1281-98. doi: 10.3945/ajcn.112.044321. Epub 2012 Oct 24.

    PubMed 23097268

  • Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29.

    PubMed 25926512

  • Samson MM, Meeuwsen IB, Crowe A, Dessens JA, Duursma SA, Verhaar HJ. Relationships between physical performance measures, age, height and body weight in healthy adults. Age Ageing. 2000 May;29(3):235-42. doi: 10.1093/ageing/29.3.235.

    PubMed 10855906

  • Phillips SK, Rook KM, Siddle NC, Bruce SA, Woledge RC. Muscle weakness in women occurs at an earlier age than in men, but strength is preserved by hormone replacement therapy. Clin Sci (Lond). 1993 Jan;84(1):95-8. doi: 10.1042/cs0840095.

    PubMed 8382141

  • Brehm BJ, D'Alessio DA. Benefits of high-protein weight loss diets: enough evidence for practice? Curr Opin Endocrinol Diabetes Obes. 2008 Oct;15(5):416-21. doi: 10.1097/MED.0b013e328308dc13.

    PubMed 18769212

  • Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4.

    PubMed 25475435

  • Krebs M, Krssak M, Bernroider E, Anderwald C, Brehm A, Meyerspeer M, Nowotny P, Roth E, Waldhausl W, Roden M. Mechanism of amino acid-induced skeletal muscle insulin resistance in humans. Diabetes. 2002 Mar;51(3):599-605. doi: 10.2337/diabetes.51.3.599.

    PubMed 11872656

  • Robinson MM, Soop M, Sohn TS, Morse DM, Schimke JM, Klaus KA, Nair KS. High insulin combined with essential amino acids stimulates skeletal muscle mitochondrial protein synthesis while decreasing insulin sensitivity in healthy humans. J Clin Endocrinol Metab. 2014 Dec;99(12):E2574-83. doi: 10.1210/jc.2014-2736.

    PubMed 25222757

  • Linn T, Geyer R, Prassek S, Laube H. Effect of dietary protein intake on insulin secretion and glucose metabolism in insulin-dependent diabetes mellitus. J Clin Endocrinol Metab. 1996 Nov;81(11):3938-43. doi: 10.1210/jcem.81.11.8923841.

    PubMed 8923841

Questions about this trial

What is this clinical trial studying?

A study testing Normoprotein diet with animal protein, Normoprotein diet with vegetable protein and High-protein diet with animal protein in people with Obesity and Insulin Resistance, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resistance insulin (time frame: Baseline to 1-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03627104, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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