Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714438
• Other study ID #: CT-MS-LYZ
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2019
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 30, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Tolerance
• Insulin Resistance

Intervention

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.

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Järvinen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Total Insulin Secretion	Insulinogenic index calculated as ?AUC insulin /(?AUC glucose	After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Primary	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	Body Weight	Measured with minimal clothing and bare feet	At baseline of the study
Secondary	Body Mass Index (BMI)	Calculated with the Quetelet index	At baseline of the study
Secondary	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
Secondary	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
Secondary	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
Secondary	Total Cholesterol (TC)	Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.	At baseline of the study
Secondary	Triglycerides (TG)	Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.	At baseline of the study
Secondary	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
Secondary	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
Secondary	Very Low Density Lipoprotein (VLDL)	Estimated by standardized techniques	At baseline of the study
Secondary	Levels of aspartate aminotransferase in blood	Estimated by standardized techniques	At baseline of the study
Secondary	Levels of alanine aminotransferase in blood	Estimated by standardized techniques	At baseline of the study
Secondary	Levels of creatinine in blood	Estimated by standardized techniques	At baseline of the study
Secondary	Levels of uric acid in blood	Estimated by standardized techniques	At baseline of the study