Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

Overview

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.

Full Title of Study: “Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 11, 2018

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

  • Drug: Medicago Sativa
    • Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
  • Dietary Supplement: Placebo
    • Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.

Arms, Groups and Cohorts

  • Experimental: Medicago sativa
    • 1,500 mg unique dose, 30 min before the oral glucose tolerance test.
  • Placebo Comparator: Placebo
    • 1,500 mg unique dose, 30 min before the oral glucose tolerance test.

Clinical Trial Outcome Measures

Primary Measures

  • Fasting plasma glucose (FPG)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Body Weight
    • Time Frame: At baseline of the study
    • Measured with minimal clothing and bare feet
  • Body Mass Index (BMI)
    • Time Frame: At baseline of the study
    • Calculated with the Quetelet index
  • Waist circumference (WC)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
  • Total Cholesterol (TC)
    • Time Frame: At baseline of the study
    • Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.
  • Triglycerides (TG)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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.
  • Very Low Density Lipoprotein (VLDL)
    • Time Frame: At baseline of the study
    • Estimated by standardized techniques
  • Levels of aspartate aminotransferase in blood
    • Time Frame: At baseline of the study
    • Estimated by standardized techniques
  • Levels of alanine aminotransferase in blood
    • Time Frame: At baseline of the study
    • Estimated by standardized techniques
  • Levels of creatinine in blood
    • Time Frame: At baseline of the study
    • Estimated by standardized techniques
  • Levels of uric acid in blood
    • Time Frame: At baseline of the study
    • Estimated by standardized techniques

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Guadalajara
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lizet Yadira Rosales Rivera, Researcher Professor – University of Guadalajara
  • Overall Official(s)
    • Lizet Yadira Rosales-Rivera, PhD Science, Principal Investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

References

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.

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.

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.

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.

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