Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
NCT ID: NCT03627104
Last Updated: 2020-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-09-03
2020-01-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Normoprotein diet with animal protein
The patient will intake the diet assigned for a month
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
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
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
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%).
Interventions
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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
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
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
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%).
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
60 Years
ALL
No
Sponsors
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Martha Guevara Cruz
MD and PhD.
Principal Investigators
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Martha Guevara-Cruz, Dr
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Locations
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Martha Guevara Cruz
Mexico City, , Mexico
Countries
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References
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Klein S. Outcome success in obesity. Obes Res. 2001 Nov;9 Suppl 4:354S-358S. doi: 10.1038/oby.2001.142.
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.
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.
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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.
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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.
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.
Sluijs I, Beulens JW, van der A DL, Spijkerman AM, Grobbee DE, van der Schouw YT. Dietary intake of total, animal, and vegetable protein and risk of type 2 diabetes in the European Prospective Investigation into Cancer and Nutrition (EPIC)-NL study. Diabetes Care. 2010 Jan;33(1):43-8. doi: 10.2337/dc09-1321. Epub 2009 Oct 13.
Tinker LF, Sarto GE, Howard BV, Huang Y, Neuhouser ML, Mossavar-Rahmani Y, Beasley JM, Margolis KL, Eaton CB, Phillips LS, Prentice RL. Biomarker-calibrated dietary energy and protein intake associations with diabetes risk among postmenopausal women from the Women's Health Initiative. Am J Clin Nutr. 2011 Dec;94(6):1600-6. doi: 10.3945/ajcn.111.018648. Epub 2011 Nov 9.
Rietman A, Schwarz J, Tome D, Kok FJ, Mensink M. High dietary protein intake, reducing or eliciting insulin resistance? Eur J Clin Nutr. 2014 Sep;68(9):973-9. doi: 10.1038/ejcn.2014.123. Epub 2014 Jul 2.
Schwingshackl L, Hoffmann G. Long-term effects of low-fat diets either low or high in protein on cardiovascular and metabolic risk factors: a systematic review and meta-analysis. Nutr J. 2013 Apr 15;12:48. doi: 10.1186/1475-2891-12-48.
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Hattersley JG, Pfeiffer AF, Roden M, Petzke KJ, Hoffmann D, Rudovich NN, Randeva HS, Vatish M, Osterhoff M, Goegebakan O, Hornemann S, Nowotny P, Machann J, Hierholzer J, von Loeffelholz C, Mohlig M, Arafat AM, Weickert MO. Modulation of amino acid metabolic signatures by supplemented isoenergetic diets differing in protein and cereal fiber content. J Clin Endocrinol Metab. 2014 Dec;99(12):E2599-609. doi: 10.1210/jc.2014-2302.
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Serralde-Zuniga AE, Guevara-Cruz M, Tovar AR, Herrera-Hernandez MF, Noriega LG, Granados O, Torres N. Omental adipose tissue gene expression, gene variants, branched-chain amino acids, and their relationship with metabolic syndrome and insulin resistance in humans. Genes Nutr. 2014 Nov;9(6):431. doi: 10.1007/s12263-014-0431-5. Epub 2014 Sep 27.
Gonzalez-Salazar LE, Flores-Lopez A, Serralde-Zuniga AE, Avila-Nava A, Medina-Vera I, Hernandez-Gomez KG, Guizar-Heredia R, Ontiveros EP, Infante-Sierra H, Palacios-Gonzalez B, Velazquez-Villegas LA, Ortiz-Guiterrez S, Vazquez-Manjarrez N, Aguirre-Tostado PI, Vigil-Martinez A, Torres N, Tovar AR, Guevara-Cruz M. Effect of dietary protein on serum hepcidin and iron in adults with obesity and insulin resistance: A randomized single blind clinical trial. Nutr Metab Cardiovasc Dis. 2025 May;35(5):103785. doi: 10.1016/j.numecd.2024.10.023. Epub 2024 Nov 7.
Gonzalez-Salazar LE, Pichardo-Ontiveros E, Palacios-Gonzalez B, Vigil-Martinez A, Granados-Portillo O, Guizar-Heredia R, Flores-Lopez A, Medina-Vera I, Heredia-G-Canton PK, Hernandez-Gomez KG, Castelan-Licona G, Arteaga-Sanchez L, Serralde-Zuniga AE, Avila-Nava A, Noriega-Lopez LG, Reyes-Garcia JG, Zerrweck C, Torres N, Tovar AR, Guevara-Cruz M. Effect of the intake of dietary protein on insulin resistance in subjects with obesity: a randomized controlled clinical trial. Eur J Nutr. 2021 Aug;60(5):2435-2447. doi: 10.1007/s00394-020-02428-5. Epub 2020 Nov 3.
Other Identifiers
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2373
Identifier Type: -
Identifier Source: org_study_id
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