Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults

Conditions
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Glucose Tolerance

Intervention / Treatment
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* Drug: Medicago Sativa
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting plasma glucose ≤99 mg/dL. Two hours postload plasma glucose (100 a 139 mg/dL). Body mass Index: 25 -39.9 kg/m2. body weight stable over the last 3 months. Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests. Sedentary. Nonsmokers. Body weight unchanged upper to 5% for at least 3 moths before the study. Exclusion Criteria: Women in pregnancy and/or breastfeeding Physical or mental disability that makes it impossible to perform the intervention. Diagnosis of hypertension or heart failure. Untreated thyroid disease. Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering). Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes. Diagnosis of renal disease or creatinine >1.5 mg/dL. Diagnosis of prediabetes: Fasting plasma glucose ≥100 mg/dL and/or 2h-OGTT ≥140mg/dL and/or glycated hemoglobin A1c (A1C) between 5.7 - 6-4 %. Diagnosis of Type 2 Diabetes Mellitus (T2DM): Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg/dL . Total Cholesterol ≥ 280 mg/dL. Triglycerides ≥ 300 mg/dL. Known allergy to calcined magnesia or Medicago sativa.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medicago sativa<br>1,500 mg unique dose, 30 min before the oral glucose tolerance test. | Drug: Medicago Sativa<br>* Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.<br>* Other names: Lucerne;|
| Placebo Comparator: Placebo<br>1,500 mg unique dose, 30 min before the oral glucose tolerance test. | Dietary Supplement: Placebo<br>* Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medicago sativa, Insulin secretion, Insulin Sensitivity