Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- First Phase of Insulin Secretion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting plasma glucose ≤99 mg/dL.
- •Two hours postload plasma glucose (100 a 139 mg/dL).
- •Body mass Index: 25 -39.9 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Medicago sativa
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
干预措施: Medicago Sativa (Drug)
Placebo
1,500 mg unique dose, 30 min before the oral glucose tolerance test.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
First Phase of Insulin Secretion
时间窗: 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).
Total Insulin Secretion
时间窗: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose
Fasting plasma glucose (FPG)
时间窗: 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 hour oral glucose tolerance test (2h-PG)
时间窗: 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
Insulin sensitivity
时间窗: 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)\]
次要结局
- Systolic blood pressure (SBP)(At baseline of the study)
- Body Mass Index (BMI)(At baseline of the study)
- Body Weight(At baseline of the study)
- Waist circumference (WC)(At baseline of the study)
- Diastolic Blood pressure (DBP)(At baseline of the study)
- High Density Lipoprotein Cholesterol (HDL- C)(At baseline of the study)
- Low Density Lipoprotein Cholesterol (LDL-C)(At baseline of the study)
- Very Low Density Lipoprotein (VLDL)(At baseline of the study)
- Levels of aspartate aminotransferase in blood(At baseline of the study)
- Levels of alanine aminotransferase in blood(At baseline of the study)
- Levels of creatinine in blood(At baseline of the study)
- Levels of uric acid in blood(At baseline of the study)
- Total Cholesterol (TC)(At baseline of the study)
- Triglycerides (TG)(At baseline of the study)
研究者
Lizet Yadira Rosales Rivera
Researcher Professor
University of Guadalajara