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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Chlorella capsules 1500 mg/day
Starch 1500 mg
Amir Mahdi Hosseini
Tehran, Iran
HbA1c changes
Serum HbA1c concentration
Time frame: Baseline and after 8 weeks
FBS changes
Serum glucose concentration
Time frame: Baseline and after 8 weeks
Insulin sensitivity changes
HOMA-IR
Time frame: Baseline and after 8 weeks
Triglyceride changes
Serum TG concentration
Time frame: Baseline and after 8 weeks
Total cholesterol changes
Serum TC concentration
Time frame: Baseline and after 8 weeks
HDL-Cholesterol changes
Serum HDL concentration
Time frame: Baseline and after 8 weeks
Weight change
Body weight of participants
Time frame: Baseline and after 8 weeks
Systolic blood pressure changes
Systolic blood pressure
Time frame: Baseline and after 8 weeks
Diastolic blood pressure changes
Diastolic blood pressure
Time frame: Baseline and after 8 weeks
Anxiety score changes
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.
Time frame: Baseline and after 8 weeks
Depression score changes
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.
Time frame: Baseline and after 8 weeks
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