Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

University of Guadalajara

Status and phase

Completed

Phase 2

Conditions

Glucose Tolerance

Treatments

Dietary Supplement: Placebo

Drug: Medicago Sativa

Study type

Interventional

Funder types

Other

Identifiers

NCT03714438

CT-MS-LYZ

Details and patient eligibility

About

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 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.

Enrollment

15 patients

Sex

All

Ages

30 to 40 years old

Volunteers

No Healthy Volunteers

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.