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Completed

NCT Number: NCT03714438

Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy 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.

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Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medicago Sativa

Drug

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

Other names: Alfalfa, Lucerne

Placebo

Dietary Supplement

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

Primary outcomes

  1. Fasting plasma glucose (FPG)

    Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

    Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.

  2. 2 hour oral glucose tolerance test (2h-PG)

    Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

    Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L

  3. First Phase of Insulin Secretion

    Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

    calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L).

  4. Total Insulin Secretion

    Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

    Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose

  5. Insulin sensitivity

    Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

    Matsuda index (insulin sensitivity) calculated as [10,000/square root of (glucose 0' X insulin 0')] (mean glucose X mean insulin during 2h-OGTT)]

Secondary outcomes

  1. Body Weight

    Time frame: At baseline of the study

    Measured with minimal clothing and bare feet

  2. Body Mass Index (BMI)

    Time frame: At baseline of the study

    Calculated with the Quetelet index

  3. Waist circumference (WC)

    Time frame: At baseline of the study

    Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters.

  4. Systolic blood pressure (SBP)

    Time frame: At baseline of the study

    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

  5. Diastolic Blood pressure (DBP)

    Time frame: At baseline of the study

    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

  6. Total Cholesterol (TC)

    Time frame: At baseline of the study

    Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.

  7. Triglycerides (TG)

    Time frame: At baseline of the study

    Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.

  8. High Density Lipoprotein Cholesterol (HDL- C)

    Time frame: At baseline of the study

    Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.

  9. Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: At baseline of the study

    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.

  10. Very Low Density Lipoprotein (VLDL)

    Time frame: At baseline of the study

    Estimated by standardized techniques

  11. Levels of aspartate aminotransferase in blood

    Time frame: At baseline of the study

    Estimated by standardized techniques

  12. Levels of alanine aminotransferase in blood

    Time frame: At baseline of the study

    Estimated by standardized techniques

  13. Levels of creatinine in blood

    Time frame: At baseline of the study

    Estimated by standardized techniques

  14. Levels of uric acid in blood

    Time frame: At baseline of the study

    Estimated by standardized techniques

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2018
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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