The Effect of Chlorella Vulgaris Supplementation on Glycemic Control, Lipid Profile and Anthropometric Measurements on Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- HbA1c changes
研究概览
简要总结
Diabetes is a chronic disease and the prevalence of diabetes mellitus is rapidly increasing as a result of population ageing, urbanization and associated lifestyle changes. Recently, the use of natural products in chronic diseases such as diabetes has gained more attention. Chlorella is a single-celled green algae that contains essential nutrients including amino acids and fatty acids as well as some vitamins and minerals. There have been some studies on the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes and diabetic mice, but none of them examined the effects of chlorella in patients with type 2 diabetes. Thus the present study designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile and anthropometric measurements in type 2 diabetic patients.
详细描述
This study is a double-blind, randomized controlled trial. 84 patients with type 2 diabetes are recruited. After informing the patients about this study and filling the consent letters, they are randomly assigned into intervention group (n=42) or placebo group (n=42) receiving 1500 mg chlorella Vulgaris or placebo daily for 8 weeks. Patients are asked not to change their regular physical activity, diet, medicine and dosage during the study. Anthropometric and blood pressure measurements are collected and 24-hour food intake recall, IPAQ physical activity, Pittsburgh Sleep Quality Assessment (PSQI) and Beck anxiety and depression questionnaires are filled by each patients at the beginning and end of the study. In addition, blood samples are collected at the beginning and end of the study to determine the changes of FBS, HbA1c, insulin concentration and insulin resistance (HOMA-IR) and lipid profile.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study is a double-blind, randomized controlled trial. Subjects will be randomly allocated into two groups and each one will receive the supplement (Chlorella Vulgaris) or placebo for 8 weeks. To prevent selection bias, the study participants, investigators and the laboratory staff will be all blinded to treatment assignment.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tendency to participate
- •Clinical diagnosis of T2DM
- •Having T2DM for at least 1 year
- •Range of HbA1c between 6.5% and 8.5%
- •Triglyceride range lower than 300 mg/dl
排除标准
- •Insulin dependent patients
- •Smoking and alcohol consumption
- •Patients with cardiovascular disease, liver disease, renal and thyroid diseases
- •Pregnancy, lactation and menopause
- •Intake of multivitamin and mineral supplements
结局指标
主要结局
HbA1c changes
时间窗: Baseline and after 8 weeks
Serum HbA1c concentration
次要结局
- Systolic blood pressure changes(Baseline and after 8 weeks)
- Total cholesterol changes(Baseline and after 8 weeks)
- Weight change(Baseline and after 8 weeks)
- HDL-Cholesterol changes(Baseline and after 8 weeks)
- Insulin sensitivity changes(Baseline and after 8 weeks)
- FBS changes(Baseline and after 8 weeks)
- Diastolic blood pressure changes(Baseline and after 8 weeks)
- Triglyceride changes(Baseline and after 8 weeks)
- Depression score changes(Baseline and after 8 weeks)
- Anxiety score changes(Baseline and after 8 weeks)
研究者
Dr. Behnood Abbasi
Clinical Professor
Islamic Azad University, Tehran