Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

NCT ID: NCT03714438

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2018-01-30

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.

Conditions

Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Medicago sativa

1,500 mg unique dose, 30 min before the oral glucose tolerance test.

Group Type: EXPERIMENTAL

Medicago Sativa

Intervention Type: DRUG

Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.

Placebo

1,500 mg unique dose, 30 min before the oral glucose tolerance test.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.

Interventions

Medicago Sativa

Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.

Intervention Type: DRUG

Placebo

Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Alfalfa; Lucerne

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Lizet Yadira Rosales Rivera

Researcher Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lizet Yadira Rosales-Rivera, PhD Science

Role: PRINCIPAL_INVESTIGATOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Locations

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

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.

Reference Type: BACKGROUND

PMID: 27389083 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22744951 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8137688 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10868854 (View on PubMed)

Other Identifiers

CT-MS-LYZ

Identifier Type: -

Identifier Source: org_study_id