Obesity Clinical Trial
Official title:
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
NCT number | NCT03627104 |
Other study ID # | 2373 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 3, 2018 |
Est. completion date | January 1, 2020 |
Verified date | September 2018 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Martha Guevara Cruz | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
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. Review. — View Citation
Hattersley JG, Pfeiffer AF, Roden M, Petzke KJ, Hoffmann D, Rudovich NN, Randeva HS, Vatish M, Osterhoff M, Goegebakan Ö, Hornemann S, Nowotny P, Machann J, Hierholzer J, von Loeffelholz C, Möhlig 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. — View Citation
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. Review. — View Citation
Klein S. Outcome success in obesity. Obes Res. 2001 Nov;9 Suppl 4:354S-358S. Review. — View Citation
Krebs M, Krssak M, Bernroider E, Anderwald C, Brehm A, Meyerspeer M, Nowotny P, Roth E, Waldhäusl W, Roden M. Mechanism of amino acid-induced skeletal muscle insulin resistance in humans. Diabetes. 2002 Mar;51(3):599-605. — View Citation
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. Epub 2015 Apr 29. — View Citation
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. — View Citation
Lynch CJ, Adams SH. Branched-chain amino acids in metabolic signalling and insulin resistance. Nat Rev Endocrinol. 2014 Dec;10(12):723-36. doi: 10.1038/nrendo.2014.171. Epub 2014 Oct 7. Review. — View Citation
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. — View Citation
Rietman A, Schwarz J, Tomé 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. Review. — View Citation
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. — View Citation
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. — View Citation
Schooneman MG, Vaz FM, Houten SM, Soeters MR. Acylcarnitines: reflecting or inflicting insulin resistance? Diabetes. 2013 Jan;62(1):1-8. doi: 10.2337/db12-0466. Review. — View Citation
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. Review. — View Citation
Serralde-Zúñiga AE, Guevara-Cruz M, Tovar AR, Herrera-Hernández 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline to 1-month | |
Secondary | Amino acid profile | Change in the concentration of the amino acid profile, mainly of branched chain amino acids | Baseline to 1-month | |
Secondary | Change in body composition | Change in fat mass, lean mass and skeletal muscle mass percentage | Baseline to 1-month | |
Secondary | Change in body weight | change in body weight before and after of dietary intervention | Baseline to 1-month | |
Secondary | Change in waist circumference | Change in waist circumference before and after of dietary intervention | Baseline to 1-month | |
Secondary | Change in grip strength | Change in grip strength before and after the intervention by dynamometry | Baseline to 1-month | |
Secondary | Change in respiratory quotient | The respiratory coefficient will be determined by indirect calorimetry | Baseline to 1-month | |
Secondary | Change in glucose serum | The concentration of serum glucose will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in total cholesterol serum | The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in HDL cholesterol serum | The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in triglycerides serum | The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in LDL cholesterol serum | The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in free fatty acids serum | The concentration of free fatty acids will be determined before and after the intervention | Baseline to 1-month | |
Secondary | Change liver function tests | The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention | Baseline to 1-month | |
Secondary | Change in concentration of leptin serum | The concentration of serum leptin will be determined by ELISA kit before and after the intervention | Baseline to 1-month | |
Secondary | Change in concentration of adiponectin serum | The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention | Baseline to 1-month | |
Secondary | 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 | Baseline to 1-month | |
Secondary | Change in systolic and diastolic blood pressure | the blod pressure will be determined before and after the intervention | Baseline to 1-month | |
Secondary | 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 | Baseline to 1- month |
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