Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
NCT Number: NCT03714438
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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Notify Me30 year–40 year
All sexes
Interventional
Phase 2
Guadalajara, Jalisco, 44340, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
Other names: Alfalfa, Lucerne
Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
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.
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
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).
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
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)]
Time frame: At baseline of the study
Measured with minimal clothing and bare feet
Time frame: At baseline of the study
Calculated with the Quetelet index
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.
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
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
Time frame: At baseline of the study
Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.
Time frame: At baseline of the study
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
Time frame: At baseline of the study
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
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.
Time frame: At baseline of the study
Estimated by standardized techniques
Time frame: At baseline of the study
Estimated by standardized techniques
Time frame: At baseline of the study
Estimated by standardized techniques
Time frame: At baseline of the study
Estimated by standardized techniques
Time frame: At baseline of the study
Estimated by standardized techniques
University of Guadalajara
Other
Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
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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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