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

Dr. Behnood Abbasi

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Chlorella Vulgaris

Study type: Interventional

Funder types: Other

Identifiers

NCT03625856

IR.TUMS.EMRI.REC.1396.00195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

1500 mg Chlorella Vulgaris capsule

Treatment:

Dietary Supplement: Chlorella Vulgaris

Control

Placebo Comparator group

Description:

1500 mg placebo (starch)

Treatment:

Dietary Supplement: Placebo