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Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.
A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be carrie out in 15 healthy, sedentary individuals of both genders, who meet the following inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood pressure (<130/90 mmHg), body mass index of 25 to 29.9 kg/m2, no taking any medication known to affect glucose tolerance, nondrinkers and nonsmokers. No pregnant, and lactation estate for female participants. They will be select from the same neighborhood and socioeconomic status.
After a fasting blood sample patients will be assigned at random-order through a closed-envelope selection, to receive one of two possible sequences during which they received either single oral doses of Medicago sativa or homologated placebo in 1,500 mg and were crossover with a difference of at least 7 days washout interval. Thirty minutes after each intervention patients underwent a 75-g oral glucose tolerant test (OGTT). Area under the curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity will be calculate for each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medicago sativa | Experimental | 1,500 mg unique dose, 30 min before the oral glucose tolerance test. |
|
| Placebo | Placebo Comparator | 1,500 mg unique dose, 30 min before the oral glucose tolerance test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medicago Sativa | Drug | Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose (FPG) | Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L. | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. |
| 2 hour oral glucose tolerance test (2h-PG) | Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. |
| First Phase of Insulin Secretion | calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L). | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. |
| Total Insulin Secretion | Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. |
| Insulin sensitivity | Matsuda index (insulin sensitivity) calculated as [10,000/square root of (glucose 0' X insulin 0')] (mean glucose X mean insulin during 2h-OGTT)] | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Measured with minimal clothing and bare feet | At baseline of the study |
| Body Mass Index (BMI) | Calculated with the Quetelet index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizet Yadira Rosales-Rivera, PhD Science | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27389083 | Background | Abdul-Ghani M, DeFronzo RA, Jayyousi A. Prediabetes and risk of diabetes and associated complications: impaired fasting glucose versus impaired glucose tolerance: does it matter? Curr Opin Clin Nutr Metab Care. 2016 Sep;19(5):394-399. doi: 10.1097/MCO.0000000000000307. | |
| 22744951 | Background | Gawel E. Chemical composition of lucerne leaf extract (EFL) and its applications as a phytobiotic in human nutrition. Acta Sci Pol Technol Aliment. 2012 Jul-Sep;11(3):303-10. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test. |
|
| At baseline of the study |
| Waist circumference (WC) | Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters. | At baseline of the study |
| Systolic blood pressure (SBP) | 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 expressed on mmHg | At baseline of the study |
| Diastolic Blood pressure (DBP) | 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 diastolic blood pressure expressed on mmHg | At baseline of the study |
| Total Cholesterol (TC) | Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L. | At baseline of the study |
| Triglycerides (TG) | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. | At baseline of the study |
| High Density Lipoprotein Cholesterol (HDL- C) | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. | At baseline of the study |
| Low Density Lipoprotein Cholesterol (LDL-C) | Determined after overnight fasting (10 to 12-h), calculated with the Friedewald equation LDL-C (mmol/L) = TC (mmol/L) - HDL-C (mmol/L) - [TG (mmol/L)/2.2] and very low-density lipoprotein (VLDL) for the proportion of TG (mmol/L)/2.2. Expressed in mmol/L. | At baseline of the study |
| Very Low Density Lipoprotein (VLDL) | Estimated by standardized techniques | At baseline of the study |
| Levels of aspartate aminotransferase in blood | Estimated by standardized techniques | At baseline of the study |
| Levels of alanine aminotransferase in blood | Estimated by standardized techniques | At baseline of the study |
| Levels of creatinine in blood | Estimated by standardized techniques | At baseline of the study |
| Levels of uric acid in blood | Estimated by standardized techniques | At baseline of the study |
| 8137688 | Background | 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. |
| 10868854 | Background | 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. |