EFFECT OF Salvia Hispanica L. ( CHIA ) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS IN PATIENTS IN THE NATIONAL MEDICAL CENTER WEST OF THE MEXICAN SOCIAL SECURITY INSTITUTE
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in serum glucose levels
研究概览
简要总结
The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition
详细描述
The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
- •Subject wishing to participate in the study by written consent.
- •Instituto Mexicano del Seguro Social beneficiaries subject
- •Subject who not requiring modification of medical treatment for MS in the recruitment period.
排除标准
- •Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
- •Diabetic neuropathy.
- •Post menopause
- •Intestinal malabsorption diseases .
- •Type 2 diabetes with HbA1c > 8.5 %
- •Systolic and diastolic blood pressure >140/90 mmHg.
- •Triglycerides > 300 mg/dL.
- •LDL cholesterol >160mg/dL.
- •Systemic autoimmune diseases .
- •Cirrhosis or liver failure .
- •Subject infected with human immunodeficiency virus or acquired immunodeficiency syndrome .
- •Diagnosis of cancer with active disease.
- •Subject previously undergoing bariatric surgery.
- •Pregnancy or lactation.
- •Alcoholism and drug addiction.
- •Subject who consume high fiber dietary supplements and / or omega 3 acids.
- •Subject taking anorexic drugs.
- •Subject under diet for weight loss implemented by a health professional.
研究组 & 干预措施
Free diet plus Chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet
干预措施: Chia (Dietary Supplement)
Normocaloric diet plus chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
干预措施: Chia (Dietary Supplement)
Normocaloric diet plus chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
干预措施: Normocaloric diet (Behavioral)
Normocaloric diet plus oatmeal
This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet
干预措施: Normocaloric diet (Behavioral)
Normocaloric diet
This subjects will only go under a normocaloric diet for 90 days
干预措施: Normocaloric diet (Behavioral)
Normocaloric diet plus oatmeal
This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet
干预措施: Oatmeal (Dietary Supplement)
结局指标
主要结局
Change in serum glucose levels
时间窗: 94 days (plus or minus 4 days)
Fasting, postprandial and post challenge oral test glucose and HbA1c
Variation in lipid profile
时间窗: 94 days (plus or minus 4 days)
Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol
次要结局
- Modification in waist circumference(94 days (plus or minus 4 days))
- Variation in body weight(94 days (plus or minus 4 days))
- Modification in insulin resistance(94 days (plus or minus 4 days))
- Change in diastolic blood pressure(94 days (plus or minus 4 days))
- Change in systolic blood pressure(94 days (plus or minus 4 days))
研究者
Ana Elena Perez Verdin
Dr.
Instituto Mexicano del Seguro Social