The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Dietary Supplement: Chlorella VulgarisDietary Supplement: Placebo
- Registration Number
- NCT03625856
- Lead Sponsor
- Dr. Behnood Abbasi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Chlorella Vulgaris 1500 mg Chlorella Vulgaris capsule Control Placebo 1500 mg placebo (starch)
- Primary Outcome Measures
Name Time Method HbA1c changes Baseline and after 8 weeks Serum HbA1c concentration
- Secondary Outcome Measures
Name Time Method Weight change Baseline and after 8 weeks Body weight of participants
HDL-Cholesterol changes Baseline and after 8 weeks Serum HDL concentration
Insulin sensitivity changes Baseline and after 8 weeks HOMA-IR
Systolic blood pressure changes Baseline and after 8 weeks Systolic blood pressure
Total cholesterol changes Baseline and after 8 weeks Serum TC concentration
FBS changes Baseline and after 8 weeks Serum glucose concentration
Diastolic blood pressure changes Baseline and after 8 weeks Diastolic blood pressure
Triglyceride changes Baseline and after 8 weeks Serum TG concentration
Depression score changes Baseline and after 8 weeks The beck depression inventory (BDI) is used for the evaluations. The total range of this 21 item questionnaire is from zero to 40. BDI items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. These points are summed and the total score of 0-10 for sub-scales is considered normal,11-16 Mild mood disturbance,17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 is considered extreme depression.
Anxiety score changes Baseline and after 8 weeks The beck anxiety inventory (BAI) is used for the evaluations. The total range of this 21 item questionnaire is from zero to 63. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). These points are summed and the total score of 0-7 for sub-scales is considered nonexistence or the least form of anxiety,8-15 slight,16-25 moderate and 26-63 indicate the severe form of it.
Trial Locations
- Locations (1)
Amir Mahdi Hosseini
🇮🇷Tehran, Iran, Islamic Republic of