Clinical trial NCT03714438: Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
Official title: Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glucose Tolerance
Keywords: Medicago sativa
Insulin secretion
Insulin Sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting plasma glucose (FPG)
timeFrame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
measure: 2 hour oral glucose tolerance test (2h-PG)
timeFrame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
measure: First Phase of Insulin Secretion
timeFrame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
measure: Total Insulin Secretion
timeFrame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
measure: Insulin sensitivity
timeFrame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Secondary outcomes:
measure: Body Weight
timeFrame: At baseline of the study
measure: Body Mass Index (BMI)
timeFrame: At baseline of the study
measure: Waist circumference (WC)
timeFrame: At baseline of the study
measure: Systolic blood pressure (SBP)
timeFrame: At baseline of the study
measure: Diastolic Blood pressure (DBP)
timeFrame: At baseline of the study
measure: Total Cholesterol (TC)
timeFrame: At baseline of the study
measure: Triglycerides (TG)
timeFrame: At baseline of the study
measure: High Density Lipoprotein Cholesterol (HDL- C)
timeFrame: At baseline of the study
measure: Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: At baseline of the study
measure: Very Low Density Lipoprotein (VLDL)
timeFrame: At baseline of the study
measure: Levels of aspartate aminotransferase in blood
timeFrame: At baseline of the study
measure: Levels of alanine aminotransferase in blood
timeFrame: At baseline of the study
measure: Levels of creatinine in blood
timeFrame: At baseline of the study
measure: Levels of uric acid in blood
timeFrame: At baseline of the study
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
name: Lizet Yadira Rosales-Rivera, PhD Science
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.2337/diacare.17.2.152.
citation: 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.