Back to resultsEffect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
Primary Purpose
Glucose Tolerance
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Medicago Sativa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Tolerance focused on measuring Medicago sativa, Insulin secretion, Insulin Sensitivity
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.
Sites / Locations
- Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Medicago sativa
Placebo
Arm Description
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
Outcomes
Primary Outcome Measures
Fasting plasma glucose (FPG)
Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.
2 hour oral glucose tolerance test (2h-PG)
Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L
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).
Total Insulin Secretion
Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose
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)]
Secondary Outcome Measures
Body Weight
Measured with minimal clothing and bare feet
Body Mass Index (BMI)
Calculated with the Quetelet index
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.
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
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
Total Cholesterol (TC)
Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.
Triglycerides (TG)
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
High Density Lipoprotein Cholesterol (HDL- C)
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
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.
Very Low Density Lipoprotein (VLDL)
Estimated by standardized techniques
Levels of aspartate aminotransferase in blood
Estimated by standardized techniques
Levels of alanine aminotransferase in blood
Estimated by standardized techniques
Levels of creatinine in blood
Estimated by standardized techniques
Levels of uric acid in blood
Estimated by standardized techniques
Full Information
NCT ID
NCT03714438
First Posted
May 10, 2018
Last Updated
February 19, 2019
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT03714438
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
January 11, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Tolerance
Keywords
Medicago sativa, Insulin secretion, Insulin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medicago sativa
Arm Type
Experimental
Arm Description
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
Intervention Type
Drug
Intervention Name(s)
Medicago Sativa
Other Intervention Name(s)
Alfalfa, Lucerne
Intervention Description
Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
Primary Outcome Measure Information:
Title
Fasting plasma glucose (FPG)
Description
Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.
Time Frame
After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Title
2 hour oral glucose tolerance test (2h-PG)
Description
Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L
Time Frame
After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Title
First Phase of Insulin Secretion
Description
calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L).
Time Frame
After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Title
Total Insulin Secretion
Description
Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose
Time Frame
After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Title
Insulin sensitivity
Description
Matsuda index (insulin sensitivity) calculated as [10,000/square root of (glucose 0' X insulin 0')] (mean glucose X mean insulin during 2h-OGTT)]
Time Frame
After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Secondary Outcome Measure Information:
Title
Body Weight
Description
Measured with minimal clothing and bare feet
Time Frame
At baseline of the study
Title
Body Mass Index (BMI)
Description
Calculated with the Quetelet index
Time Frame
At baseline of the study
Title
Waist circumference (WC)
Description
Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters.
Time Frame
At baseline of the study
Title
Systolic blood pressure (SBP)
Description
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
Time Frame
At baseline of the study
Title
Diastolic Blood pressure (DBP)
Description
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
Time Frame
At baseline of the study
Title
Total Cholesterol (TC)
Description
Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.
Time Frame
At baseline of the study
Title
Triglycerides (TG)
Description
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
Time Frame
At baseline of the study
Title
High Density Lipoprotein Cholesterol (HDL- C)
Description
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
Time Frame
At baseline of the study
Title
Low Density Lipoprotein Cholesterol (LDL-C)
Description
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.
Time Frame
At baseline of the study
Title
Very Low Density Lipoprotein (VLDL)
Description
Estimated by standardized techniques
Time Frame
At baseline of the study
Title
Levels of aspartate aminotransferase in blood
Description
Estimated by standardized techniques
Time Frame
At baseline of the study
Title
Levels of alanine aminotransferase in blood
Description
Estimated by standardized techniques
Time Frame
At baseline of the study
Title
Levels of creatinine in blood
Description
Estimated by standardized techniques
Time Frame
At baseline of the study
Title
Levels of uric acid in blood
Description
Estimated by standardized techniques
Time Frame
At baseline of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizet Yadira Rosales-Rivera, PhD Science
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
27389083
Citation
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.
Results Reference
background
PubMed Identifier
22744951
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.
Results Reference
background
PubMed Identifier
8137688
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.
Results Reference
background
PubMed Identifier
10868854
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.
Results Reference
background
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Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
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