Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Tolerance
• Intervention / Treatment: Drug: Medicago Sativa; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medicago sativa; 1,500 mg unique dose, 30 min before the oral glucose tolerance test.	Drug: Medicago Sativa; Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.; Other Names: Alfalfa; Lucerne
Placebo Comparator: Placebo; 1,500 mg unique dose, 30 min 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Investigators: Principal Investigator: Lizet Yadira Rosales-Rivera, PhD Science, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Insulin Sensitivity; Insulin secretion; Medicago sativa
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: CT-MS-LYZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No