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Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.
Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. |
|
| Gymnema Sylvestre | Experimental | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference (WC) | The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Week 12 |
| Triglycerides (TGs) | The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | week 12 |
| High-density Lipoprotein Cholesterol (HDL-C) | The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L. | Week 12 |
| Fasting Plasma Glucose (FPG) | The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | week 12 |
| Systolic Blood Pressure (SBP) | The SBP 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 SBP. The value was expressed on mmHg. | week 12 |
| Diastolic Blood Pressure (DBP) | The DBP 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 DBP. The value was expressed on mmHg. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight (BW) | The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | week 12 |
| Body Mass Index (BMI) | The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. |
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Inclusion Criteria:
Plus any two of the following four factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esperanza Martínez, PhD | Institute of Experimental and Clinical Therapeutics | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17964909 | Background | Lann D, LeRoith D. Insulin resistance as the underlying cause for the metabolic syndrome. Med Clin North Am. 2007 Nov;91(6):1063-77, viii. doi: 10.1016/j.mcna.2007.06.012. | |
| 17192339 | Background | Abdul-Ghani MA, Matsuda M, Balas B, DeFronzo RA. Muscle and liver insulin resistance indexes derived from the oral glucose tolerance test. Diabetes Care. 2007 Jan;30(1):89-94. doi: 10.2337/dc06-1519. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
| FG001 | Gymnema Sylvestre | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
| BG001 | Gymnema Sylvestre |
| 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 | Waist Circumference (WC) | The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat). | Posted | Mean | Standard Deviation | cm | Week 12 |
|
Adverse events were collected throughout the 90 days of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | ANY | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Esperanza Martínez Abundis | Institute of Experimental and Clinical Therapeutics | +52-33-10-58-52-00 | 34211 | esperanzamartnezabundi@yahoo.com |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C075206 | Gurmarin protein, Gymnema sylvestre |
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| Gymnema Sylvestre | Drug | Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
|
|
| Total Insulin Secretion | The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose). | Week 12 |
| First Phase of Insulin Secretion | The 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'). | week 12 |
| Insulin Sensitivity | The 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)]. | week 12 |
| week 12 |
| Total Cholesterol (TC) | The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | week 12 |
| Low-density Lipoprotein Cholesterol (LDL-C) | The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L. | Week 12 |
| Very-low Density Lipoprotein (VLDL) | The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L. | week 12 |
| 2-hour Postload Plasma Glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | week 12 |
| Area Under the Curve of Glucose (AUCG) | The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min. | week 12 |
| Area Under the Curve of Insulin (AUCI) | The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min. | week 12 |
| 20516533 | Background | Sandeep S, Gokulakrishnan K, Velmurugan K, Deepa M, Mohan V. Visceral & subcutaneous abdominal fat in relation to insulin resistance & metabolic syndrome in non-diabetic south Indians. Indian J Med Res. 2010 May;131:629-35. |
| 20812281 | Result | Al-Romaiyan A, Liu B, Asare-Anane H, Maity CR, Chatterjee SK, Koley N, Biswas T, Chatterji AK, Huang GC, Amiel SA, Persaud SJ, Jones PM. A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro. Phytother Res. 2010 Sep;24(9):1370-6. doi: 10.1002/ptr.3125. |
| 11411567 | Result | Shigematsu N, Asano R, Shimosaka M, Okazaki M. Effect of administration with the extract of Gymnema sylvestre R. Br leaves on lipid metabolism in rats. Biol Pharm Bull. 2001 Jun;24(6):713-7. doi: 10.1248/bpb.24.713. |
| 2259217 | Result | Baskaran K, Kizar Ahamath B, Radha Shanmugasundaram K, Shanmugasundaram ER. Antidiabetic effect of a leaf extract from Gymnema sylvestre in non-insulin-dependent diabetes mellitus patients. J Ethnopharmacol. 1990 Oct;30(3):295-300. doi: 10.1016/0378-8741(90)90108-6. |
| 12622244 | Result | Porchezhian E, Dobriyal RM. An overview on the advances of Gymnema sylvestre: chemistry, pharmacology and patents. Pharmazie. 2003 Jan;58(1):5-12. |
| 2451154 | Result | Koshu K, Hirota S, Sonobe M, Takahashi S, Takaku A, Saito T, Ushijima T. [Continuous recording of cerebral blood flow by means of thermal diffusion method using Peltier stack]. Neurol Med Chir (Tokyo). 1987 Aug;27(8):724-8. doi: 10.2176/nmc.27.724. No abstract available. Japanese. |
| 23852298 | Result | Bhansali S, Shafiq N, Pandhi P, Singh AP, Singh I, Singh PK, Sharma S, Malhotra S. Effect of a deacyl gymnemic acid on glucose homeostasis & metabolic parameters in a rat model of metabolic syndrome. Indian J Med Res. 2013 Jun;137(6):1174-9. |
| 24511547 | Result | Tiwari P, Mishra BN, Sangwan NS. Phytochemical and pharmacological properties of Gymnema sylvestre: an important medicinal plant. Biomed Res Int. 2014;2014:830285. doi: 10.1155/2014/830285. Epub 2014 Jan 6. |
| 25284929 | Result | Kumar V, Bhandari U, Tripathi CD, Khanna G. Protective Effect of Gymnema sylvestre Ethanol Extract on High Fat Diet-induced Obese Diabetic Wistar Rats. Indian J Pharm Sci. 2014 Jul;76(4):315-22. |
| 23876572 | Result | Astell KJ, Mathai ML, Su XQ. Plant extracts with appetite suppressing properties for body weight control: a systematic review of double blind randomized controlled clinical trials. Complement Ther Med. 2013 Aug;21(4):407-16. doi: 10.1016/j.ctim.2013.05.007. Epub 2013 Jun 24. |
| 22911568 | Result | Al-Romaiyan A, King AJ, Persaud SJ, Jones PM. A novel extract of Gymnema sylvestre improves glucose tolerance in vivo and stimulates insulin secretion and synthesis in vitro. Phytother Res. 2013 Jul;27(7):1006-11. doi: 10.1002/ptr.4815. Epub 2012 Aug 21. |
| 15168555 | Result | Ogawa Y, Sekita K, Umemura T, Saito M, Ono A, Kawasaki Y, Uchida O, Matsushima Y, Inoue T, Kanno J. [Gymnema sylvestre leaf extract: a 52-week dietary toxicity study in Wistar rats]. Shokuhin Eiseigaku Zasshi. 2004 Feb;45(1):8-18. doi: 10.3358/shokueishi.45.8. Japanese. |
| 1695875 | Result | Okabayashi Y, Tani S, Fujisawa T, Koide M, Hasegawa H, Nakamura T, Fujii M, Otsuki M. Effect of Gymnema sylvestre, R.Br. on glucose homeostasis in rats. Diabetes Res Clin Pract. 1990 May-Jun;9(2):143-8. doi: 10.1016/0168-8227(90)90106-4. |
| 10480510 | Result | Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462. |
| 8137688 | Result | Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152. |
| 25668616 | Result | Renga B, Festa C, De Marino S, Di Micco S, D'Auria MV, Bifulco G, Fiorucci S, Zampella A. Molecular decodification of gymnemic acids from Gymnema sylvestre. Discovery of a new class of liver X receptor antagonists. Steroids. 2015 Apr;96:121-31. doi: 10.1016/j.steroids.2015.01.024. Epub 2015 Feb 7. |
| 10868854 | Result | Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Jarvinen H, Van Haeften T, Renn W, Gerich J. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care. 2000 Mar;23(3):295-301. doi: 10.2337/diacare.23.3.295. |
| 16054141 | Result | Izutani Y, Murai T, Imoto T, Ohnishi M, Oda M, Ishijima S. Gymnemic acids inhibit rabbit glyceraldehyde-3-phosphate dehydrogenase and induce a smearing of its electrophoretic band and dephosphorylation. FEBS Lett. 2005 Aug 15;579(20):4333-6. doi: 10.1016/j.febslet.2005.06.070. |
| 24856809 | Result | Wang Y, Dawid C, Kottra G, Daniel H, Hofmann T. Gymnemic acids inhibit sodium-dependent glucose transporter 1. J Agric Food Chem. 2014 Jun 25;62(25):5925-31. doi: 10.1021/jf501766u. Epub 2014 Jun 10. |
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. |
| 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 (BW) | The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference (WC) | The WC was evaluated after an overnight fast 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 (SBP) | The SBP 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 SBP. The value was expressed on mmHg. | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure (DBP) | The DBP 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 DBP. The value was expressed on mmHg. | Mean | Standard Deviation | mmHg |
|
| Triglycerides (TGs) | The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Total cholesterol (TC) | The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| high-density lipoprotein cholesterol (HDL-C) | The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Low-density lipoprotein cholesterol (LDL-C) | The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Very-low density lipoprotein (VLDL) | The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5 . The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Fasting plasma glucose (FPG) | The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| 2-hour postload plasma glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Area under the curve of glucose (AUCG) | The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min. | Mean | Standard Deviation | mmol/L/min |
|
| Area under the curve of insulin (AUCI) | The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min. | Mean | Standard Deviation | pmol/L/min |
|
| Total insulin secretion | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose). | Mean | Standard Deviation | unitless |
|
| 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 | unitless |
|
| 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 | unitless |
|
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
|
|
|
| Primary | Triglycerides (TGs) | The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | week 12 |
|
|
|
|
| Primary | High-density Lipoprotein Cholesterol (HDL-C) | The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Fasting Plasma Glucose (FPG) | The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | week 12 |
|
|
|
|
| Primary | Systolic Blood Pressure (SBP) | The SBP 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 SBP. The value was expressed on mmHg. | Posted | Mean | Standard Deviation | mmHg | week 12 |
|
|
|
|
| Primary | Diastolic Blood Pressure (DBP) | The DBP 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 DBP. The value was expressed on mmHg. | Posted | Mean | Standard Deviation | mmHg | week 12 |
|
|
|
|
| Primary | Total Insulin Secretion | The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose). | Posted | Mean | Standard Deviation | unitless | Week 12 |
|
|
|
|
| Primary | First Phase of Insulin Secretion | The 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'). | Posted | Mean | Standard Deviation | unitless | week 12 |
|
|
|
|
| Primary | Insulin Sensitivity | The 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)]. | Posted | Mean | Standard Deviation | unitless | week 12 |
|
|
|
|
| Secondary | Body Weight (BW) | The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | Posted | Mean | Standard Deviation | kg | week 12 |
|
|
|
|
| Secondary | Body Mass Index (BMI) | The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Posted | Mean | Standard Deviation | kg/m^2 | week 12 |
|
|
|
|
| Secondary | Total Cholesterol (TC) | The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | week 12 |
|
|
|
|
| Secondary | Low-density Lipoprotein Cholesterol (LDL-C) | The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Very-low Density Lipoprotein (VLDL) | The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | week 12 |
|
|
|
|
| Secondary | 2-hour Postload Plasma Glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | week 12 |
|
|
|
|
| Secondary | Area Under the Curve of Glucose (AUCG) | The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min. | Posted | Mean | Standard Deviation | mmol/L/min | week 12 |
|
|
|
|
| Secondary | Area Under the Curve of Insulin (AUCI) | The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min. | Posted | Mean | Standard Deviation | pmol/L/min | week 12 |
|
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Gymnema Sylvestre | 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. | 0 | 12 | 8 | 12 |
| Diarrhea | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Pyrosis | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Polydipsia | Metabolism and nutrition 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 |