Glucose Tolerance
Conditions
Keywords
Medicago sativa, Insulin secretion, Insulin Sensitivity
Brief summary
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
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.
Interventions
DRUGMedicago Sativa
Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
DIETARY_SUPPLEMENTPlacebo
Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose (FPG) | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L. |
| 2 hour oral glucose tolerance test (2h-PG) | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L |
| First Phase of Insulin Secretion | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L). |
| Total Insulin Secretion | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose |
| Insulin sensitivity | After the acute administration of placebo and Medicago sativa. 15 days wash period between them. | Matsuda index (insulin sensitivity) calculated as \[10,000/square root of (glucose 0' X insulin 0')\] (mean glucose X mean insulin during 2h-OGTT)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol (TC) | At baseline of the study | Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L. |
| Triglycerides (TG) | At baseline of the study | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. |
| High Density Lipoprotein Cholesterol (HDL- C) | At baseline of the study | Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L. |
| Low Density Lipoprotein Cholesterol (LDL-C) | At baseline of the study | 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. |
| Body Weight | At baseline of the study | Measured with minimal clothing and bare feet |
| Levels of aspartate aminotransferase in blood | At baseline of the study | Estimated by standardized techniques |
| Levels of alanine aminotransferase in blood | At baseline of the study | Estimated by standardized techniques |
| Levels of creatinine in blood | At baseline of the study | Estimated by standardized techniques |
| Levels of uric acid in blood | At baseline of the study | Estimated by standardized techniques |
| Very Low Density Lipoprotein (VLDL) | At baseline of the study | Estimated by standardized techniques |
| Body Mass Index (BMI) | At baseline of the study | Calculated with the Quetelet index |
| Waist circumference (WC) | At baseline of the study | Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters. |
| Systolic blood pressure (SBP) | At baseline of the study | 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 |
| Diastolic Blood pressure (DBP) | At baseline of the study | 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 |
Countries
Mexico
Outcome results
None listed