Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.
The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.
12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Resveratrol capsules, 500 mg, three times per day before meals during 90 days |
|
| Placebo | Placebo Comparator | Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides Levels at Week 12 | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Week 12 |
| High Density Lipoprotein (c-HDL) Levels at Week 12. | The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Baseline. Week 12 |
| Fasting Glucose Levels at Week 12. | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Week 12 |
| Systolic Blood Pressure at Week 12. | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 | Week 12 |
| First Phase of Insulin Secretion at Week 12. | The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12 | Week 12 |
| Total Insulin Secretion at Week 12. | The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12 | Week 12 |
| Total Insulin Sensitivity at Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at Week 12. | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Week 12 |
| Body Mass Index at Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 45037 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20823772 | Background | Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. doi: 10.1097/MCO.0b013e32833ef291. | |
| 20303945 | Background | Szkudelska K, Szkudelski T. Resveratrol, obesity and diabetes. Eur J Pharmacol. 2010 Jun 10;635(1-3):1-8. doi: 10.1016/j.ejphar.2010.02.054. Epub 2010 Mar 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Resveratrol | Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. |
| FG001 | Placebo | Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sample size was calculated in accordance of Jeyaseelan's clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Resveratrol | Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Triglycerides Levels at Week 12 | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
Adverse events were collected throughout the study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resveratrol | Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | ANY | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manuel González Ortiz | Institute of Experimental andl Clinical Therapeutics | +52-33-10-58-52-00 | 34212 | uiec@prodigy.net.mx |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D056128 | Obesity, Abdominal |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg |
|
|
The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12 |
| Week 12 |
| Waist Circumference at Week 12 | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12 | Week 12 |
| Diastolic Blood Pressure at Week 12 | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | Week 12 |
The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
| Week 12 |
| Total Cholesterol at Week 12 | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | Week 12 |
| Low Density Lipoproteins (c-LDL) at Week 12 | The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | Week 12 |
| Creatinine at Week 12. | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | Baseline. Week 12. |
| Uric Acid at Week 12. | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | Week 12. |
| 16732220 | Background | Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. doi: 10.1038/nrd2060. Epub 2006 May 26. |
| 22436213 | Background | Timmers S, Auwerx J, Schrauwen P. The journey of resveratrol from yeast to human. Aging (Albany NY). 2012 Mar;4(3):146-58. doi: 10.18632/aging.100445. |
| 20491649 | Background | Kroon PA, Iyer A, Chunduri P, Chan V, Brown L. The Cardiovascular Nutrapharmacology of Resveratrol: Pharmacokinetics, Molecular Mechanisms and Therapeutic Potential. Curr Med Chem. 2010;17(23):2442-55. doi: 10.2174/092986710791556032. |
| 20219519 | Background | Baur JA. Resveratrol, sirtuins, and the promise of a DR mimetic. Mech Ageing Dev. 2010 Apr;131(4):261-9. doi: 10.1016/j.mad.2010.02.007. Epub 2010 Feb 26. |
| 21261639 | Background | Szkudelski T, Szkudelska K. Anti-diabetic effects of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:34-9. doi: 10.1111/j.1749-6632.2010.05844.x. |
| 16626303 | Result | Zhang J. Resveratrol inhibits insulin responses in a SirT1-independent pathway. Biochem J. 2006 Aug 1;397(3):519-27. doi: 10.1042/BJ20050977. |
| 19100718 | Result | Rivera L, Moron R, Zarzuelo A, Galisteo M. Long-term resveratrol administration reduces metabolic disturbances and lowers blood pressure in obese Zucker rats. Biochem Pharmacol. 2009 Mar 15;77(6):1053-63. doi: 10.1016/j.bcp.2008.11.027. Epub 2008 Dec 3. |
| 10963727 | Result | Hung LM, Chen JK, Huang SS, Lee RS, Su MJ. Cardioprotective effect of resveratrol, a natural antioxidant derived from grapes. Cardiovasc Res. 2000 Aug 18;47(3):549-55. doi: 10.1016/s0008-6363(00)00102-4. |
| 12523673 | Result | Yu C, Shin YG, Chow A, Li Y, Kosmeder JW, Lee YS, Hirschelman WH, Pezzuto JM, Mehta RG, van Breemen RB. Human, rat, and mouse metabolism of resveratrol. Pharm Res. 2002 Dec;19(12):1907-14. doi: 10.1023/a:1021414129280. |
| 15333514 | Result | Walle T, Hsieh F, DeLegge MH, Oatis JE Jr, Walle UK. High absorption but very low bioavailability of oral resveratrol in humans. Drug Metab Dispos. 2004 Dec;32(12):1377-82. doi: 10.1124/dmd.104.000885. Epub 2004 Aug 27. |
| 11556815 | Result | Aumont V, Krisa S, Battaglia E, Netter P, Richard T, Merillon JM, Magdalou J, Sabolovic N. Regioselective and stereospecific glucuronidation of trans- and cis-resveratrol in human. Arch Biochem Biophys. 2001 Sep 15;393(2):281-9. doi: 10.1006/abbi.2001.2496. |
| 21688389 | Result | Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. doi: 10.1002/mnfr.201100143. Epub 2011 Jun 20. |
| 17086191 | Result | Baur JA, Pearson KJ, Price NL, Jamieson HA, Lerin C, Kalra A, Prabhu VV, Allard JS, Lopez-Lluch G, Lewis K, Pistell PJ, Poosala S, Becker KG, Boss O, Gwinn D, Wang M, Ramaswamy S, Fishbein KW, Spencer RG, Lakatta EG, Le Couteur D, Shaw RJ, Navas P, Puigserver P, Ingram DK, de Cabo R, Sinclair DA. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42. doi: 10.1038/nature05354. Epub 2006 Nov 1. |
| 20463039 | Result | Fischer-Posovszky P, Kukulus V, Tews D, Unterkircher T, Debatin KM, Fulda S, Wabitsch M. Resveratrol regulates human adipocyte number and function in a Sirt1-dependent manner. Am J Clin Nutr. 2010 Jul;92(1):5-15. doi: 10.3945/ajcn.2009.28435. Epub 2010 May 12. |
| 21261640 | Result | Baile CA, Yang JY, Rayalam S, Hartzell DL, Lai CY, Andersen C, Della-Fera MA. Effect of resveratrol on fat mobilization. Ann N Y Acad Sci. 2011 Jan;1215:40-7. doi: 10.1111/j.1749-6632.2010.05845.x. |
| 21569266 | Result | Alberdi G, Rodriguez VM, Miranda J, Macarulla MT, Arias N, Andres-Lacueva C, Portillo MP. Changes in white adipose tissue metabolism induced by resveratrol in rats. Nutr Metab (Lond). 2011 May 10;8(1):29. doi: 10.1186/1743-7075-8-29. |
| 22913271 | Result | Bruckbauer A, Zemel MB, Thorpe T, Akula MR, Stuckey AC, Osborne D, Martin EB, Kennel S, Wall JS. Synergistic effects of leucine and resveratrol on insulin sensitivity and fat metabolism in adipocytes and mice. Nutr Metab (Lond). 2012 Aug 22;9(1):77. doi: 10.1186/1743-7075-9-77. |
| 19819963 | Result | Ramadori G, Gautron L, Fujikawa T, Vianna CR, Elmquist JK, Coppari R. Central administration of resveratrol improves diet-induced diabetes. Endocrinology. 2009 Dec;150(12):5326-33. doi: 10.1210/en.2009-0528. Epub 2009 Oct 9. |
| 17578889 | Result | Szkudelski T. Resveratrol-induced inhibition of insulin secretion from rat pancreatic islets: evidence for pivotal role of metabolic disturbances. Am J Physiol Endocrinol Metab. 2007 Oct;293(4):E901-7. doi: 10.1152/ajpendo.00564.2006. Epub 2007 Jun 19. |
| 17112576 | Result | Lagouge M, Argmann C, Gerhart-Hines Z, Meziane H, Lerin C, Daussin F, Messadeq N, Milne J, Lambert P, Elliott P, Geny B, Laakso M, Puigserver P, Auwerx J. Resveratrol improves mitochondrial function and protects against metabolic disease by activating SIRT1 and PGC-1alpha. Cell. 2006 Dec 15;127(6):1109-22. doi: 10.1016/j.cell.2006.11.013. Epub 2006 Nov 16. |
| 18266981 | Result | Penumathsa SV, Thirunavukkarasu M, Zhan L, Maulik G, Menon VP, Bagchi D, Maulik N. Resveratrol enhances GLUT-4 translocation to the caveolar lipid raft fractions through AMPK/Akt/eNOS signalling pathway in diabetic myocardium. J Cell Mol Med. 2008 Dec;12(6A):2350-61. doi: 10.1111/j.1582-4934.2008.00251.x. |
| 21673955 | Result | Dao TM, Waget A, Klopp P, Serino M, Vachoux C, Pechere L, Drucker DJ, Champion S, Barthelemy S, Barra Y, Burcelin R, Seree E. Resveratrol increases glucose induced GLP-1 secretion in mice: a mechanism which contributes to the glycemic control. PLoS One. 2011;6(6):e20700. doi: 10.1371/journal.pone.0020700. Epub 2011 Jun 6. |
| 21385509 | Result | Brasnyo P, Molnar GA, Mohas M, Marko L, Laczy B, Cseh J, Mikolas E, Szijarto IA, Merei A, Halmai R, Meszaros LG, Sumegi B, Wittmann I. Resveratrol improves insulin sensitivity, reduces oxidative stress and activates the Akt pathway in type 2 diabetic patients. Br J Nutr. 2011 Aug;106(3):383-9. doi: 10.1017/S0007114511000316. Epub 2011 Mar 9. |
| 22219517 | Result | Crandall JP, Oram V, Trandafirescu G, Reid M, Kishore P, Hawkins M, Cohen HW, Barzilai N. Pilot study of resveratrol in older adults with impaired glucose tolerance. J Gerontol A Biol Sci Med Sci. 2012 Dec;67(12):1307-12. doi: 10.1093/gerona/glr235. Epub 2012 Jan 4. |
| 17069794 | Result | Szkudelski T. Resveratrol inhibits insulin secretion from rat pancreatic islets. Eur J Pharmacol. 2006 Dec 15;552(1-3):176-81. doi: 10.1016/j.ejphar.2006.09.046. Epub 2006 Sep 27. |
Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal. | Mean | Standard Deviation | kg |
|
| Height | Height was measured with subjects standing and the measurements were round to the nearest centimeter. | Mean | Standard Deviation | cm |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Fat Mass | Fat mass was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal | Mean | Standard Deviation | kg |
|
| Waist circumference | Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Mean | Standard Deviation | cm |
|
| Systolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg | Mean | Standard Deviation | mmHg |
|
| Glucose 0' | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2500 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mmol/l |
|
| Glucose 30' | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mmol/l |
|
| Glucose 60' | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mmol/l |
|
| Glucose 90' | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mmol/l |
|
| Glucose 120' | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mmol/l |
|
| Cholesterol | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mg/dL |
|
| HDL-c | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mg/dL |
|
| LDL-c | The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid. | Mean | Standard Deviation | mg/dL |
|
| AUC glucose | Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula. | Mean | Standard Deviation | mmol*h/L |
|
| AUC insuline | Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula. | Mean | Standard Deviation | pmol*h/L |
|
| Total insulin secretion | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose). | Mean | Standard Deviation | index |
|
| First phase of insulin secretion | First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0') | Mean | Standard Deviation | index |
|
| Insulin sensitivity | Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] | Mean | Standard Deviation | index |
|
|
|
|
| Primary | High Density Lipoprotein (c-HDL) Levels at Week 12. | The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Baseline. Week 12 |
|
|
|
|
| Primary | Fasting Glucose Levels at Week 12. | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Systolic Blood Pressure at Week 12. | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Primary | First Phase of Insulin Secretion at Week 12. | The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Total Insulin Secretion at Week 12. | The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Total Insulin Sensitivity at Week 12. | The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | Weight at Week 12. | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg | Week 12 |
|
|
|
|
| Secondary | Body Mass Index at Week 12 | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg/m2 | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol at Week 12 | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
|
|
|
| Secondary | Low Density Lipoproteins (c-LDL) at Week 12 | The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mg/dL | Week 12 |
|
|
|
|
| Secondary | Creatinine at Week 12. | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | µmol/l | Baseline. Week 12. |
|
|
|
|
| Secondary | Uric Acid at Week 12. | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | µmol/l | Week 12. |
|
|
|
|
| Primary | Waist Circumference at Week 12 | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | cm | Week 12 |
|
|
|
|
| Primary | Diastolic Blood Pressure at Week 12 | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Placebo | Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg | 0 | 12 | 4 | 12 |
| Abdominal pain | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Sickness | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Nosebleed | Blood and lymphatic system disorders | ANY | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
Not provided
Not provided
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |