Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Waist Circumference (WC)
研究概览
简要总结
The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the world and in Mexico. The current treatment involves lifestyle changes and pharmacological treatment for each of the components of MS, however, there is no single approved treatment to control all components. Celery seed (Apium graveolens L.) from the Apiaceae family contains the flavonoids apigenin and luteolin; essential oils such as d-limonene, selinene and phthalides such as 3-n-butylphthalide. Thanks to its bioactive components, celery seed has proven to be effective in treating individual MS disorders; however, most studies are in animal models and there are no clinical studies that evaluate its effectiveness on all components of the system. MS, insulin sensitivity and insulin secretion so it could appear as a new, safe and effective complementary therapy for the treatment of MS.
The aim of this study is to evaluate the effect of celery seed on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.
详细描述
A randomized, double-blind controlled clinical trial in 28 patients between 30 to 60 years of age with a diagnosis of MS according to the International Diabetes Federation (IDF) criteria without treatment and whether they voluntary accept participating and signing the informed consent.
Patients with one or more of the following criteria will be excluded: History of kidney, thyroid or liver disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, fasting glucose ≥ 126 mg/dL, triglycerides ≥ 500 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on the study variables.
Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, treatment adherence <80%, severe adverse reaction, intolerance or hypersensitivity to celery seed or placebo.
They will be assigned randomly two groups of 14 patients; one of the groups will receive 75 mg of celery seed twice at day (before breakfast and dinner) for 12 weeks.
The other group will receive homologated placebo (calcined magnesia) twice at day (before breakfast and dinner) for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized double-blind
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 30 and 60 years
- •Diagnosis of metabolic syndrome (MS) according to the IDF criteria: waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- •Fasting glucose ≥ 100 mg/dL
- •Triglycerides ≥150 mg/dL
- •HDL-c: Men ≤40 mg/dL, women ≤50 mg/dL
- •Blood pressure ≥130/85 mmHg
- •Body Mass Index from 25 to 34.9 kg/m²
- •Stable weight at least the previous last 3 months (weight variation less than 10%)
- •No pharmacological treatment for MS, insulin sensitivity and insulin secretion
- •Acceptance and signing of informed consent
排除标准
- •Pregnancy or breast-feeding
- •Glucose ≥126 mg/dL
- •Total cholesterol ≥240 mg/dL
- •Triglycerides ≥500mg/dL
- •Systolic blood pressure ≥140 mmHg
- •Diastolic blood pressure ≥90 mmHg
- •Drugs or supplements consumption with proven properties that modify the behavior of the study variables.
- •History of kidney, liver or thyroid disease
研究组 & 干预措施
Celery seed
14 patients to receive homologated intervention capsule (celery seed 150 mg) one capsule with 75 mg of celery seed, every 12 hours (before breakfast and before dinner) along 12 weeks.
干预措施: Celery Seed (Drug)
Placebo
14 patients to receive homologated placebo capsule (calcinated magnesia) one capsule with calcinated magnesia, every 12 hours (before breakfast and before dinner) along 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Waist Circumference (WC)
时间窗: Baseline to week 12 (end of intervention)
Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique
Systolic Blood Pressure (SBP)
时间窗: Baseline to week 12 (end of intervention)
Systolic Blood Pressure (SBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
Diastolic Blood Pressure (DBP)
时间窗: Baseline to week 12 (end of intervention)
Diastolic Blood Pressure (DBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
High-Density Lipoprotein (HDL-c)
时间窗: Baseline to week 12 (end of intervention)
High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level
Fasting Blood Triglycerides Concentration (TG)
时间窗: Baseline to week 12 (end of intervention)
Fasting Blood Triglycerides Concentration (TG) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get triglycerides concentration
Fasting Serum Glucose (FSG)
时间窗: Baseline to week 12 (end of intervention)
The Fasting Serum Glucose (FSG) levels will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get fasting glucose level
Insulin Sensitivity (Matsuda Index)
时间窗: Baseline to week 12 (end of intervention)
Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity
Total Insulin Secretion
时间窗: Baseline to week 12 (end of intervention)
Total insulin secretion will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.
First Phase of Insulin Secretion (Stumvoll Index)
时间窗: Baseline to week 12 (end of intervention)
The first phase if insulin secretion will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion
次要结局
- Body weight(Baseline to week 12 (end of intervention))
- Body Mass Index (BMI)(Baseline to week 12 (end of intervention))
- Body Fat Percentage(Baseline to week 12 (end of intervention))
- Total Cholesterol (TC)(Baseline to week 12 (end of intervention))
- Low Density Lipoprotein (LDL-c)(Baseline to week 12 (end of intervention))
- Very Low Density Lipoprotein (VLDL)(Baseline to week 12 (end of intervention))
- Concentration of Blood Aspartate Aminostransferase (AST)(Baseline to week 12 (end of intervention))
- Alanine Aminotransferase (ALT)(Baseline to week 12 (end of intervention))
- Creatinine(Baseline to week 12 (end of intervention))
- Uric Acid(Baseline to week 12 (end of intervention))
- Incidence of treatment-Emergent Adverse Events(Baseline to week 12 (end of intervention))
- Tolerability to treatment(Baseline to week 12 (end of intervention))
研究者
Karina Griselda Pérez Rubio
Principal Investigator
University of Guadalajara