The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Chlorella Vulgaris Supplementation on Glycemic Control, Lipid Profile and Anthropometric Measurements on Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Chlorella Vulgaris
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly allocated into two groups; Chlorella and placebo groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>1500 mg Chlorella Vulgaris capsule | Dietary Supplement: Chlorella Vulgaris<br>* Chlorella capsules 1500 mg/day<br>* Other names: Algomed;|
| Placebo Comparator: Control<br>1500 mg placebo (starch) | Dietary Supplement: Placebo<br>* Starch 1500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c changes | Serum HbA1c concentration | Baseline and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FBS changes | Serum glucose concentration | Baseline and after 8 weeks | 
| Insulin sensitivity changes | HOMA-IR | Baseline and after 8 weeks | 
| Triglyceride changes | Serum TG concentration | Baseline and after 8 weeks | 
| Total cholesterol changes | Serum TC concentration | Baseline and after 8 weeks | 
| HDL-Cholesterol changes | Serum HDL concentration | Baseline and after 8 weeks | 
| Weight change | Body weight of participants | Baseline and after 8 weeks | 
| Systolic blood pressure changes | Systolic blood pressure | Baseline and after 8 weeks | 
| Diastolic blood pressure changes | Diastolic blood pressure | 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. | 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. | Baseline and after 8 weeks |