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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625856
• Other study ID #: IR.TUMS.EMRI.REC.1396.00195
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2020
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Chlorella Vulgaris
Chlorella capsules 1500 mg/day
• Placebo
Starch 1500 mg

Locations

Country	Name	City	State
Iran, Islamic Republic of	Amir Mahdi Hosseini	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Behnood Abbasi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c changes	Serum HbA1c concentration	Baseline and after 8 weeks
Secondary	FBS changes	Serum glucose concentration	Baseline and after 8 weeks
Secondary	Insulin sensitivity changes	HOMA-IR	Baseline and after 8 weeks
Secondary	Triglyceride changes	Serum TG concentration	Baseline and after 8 weeks
Secondary	Total cholesterol changes	Serum TC concentration	Baseline and after 8 weeks
Secondary	HDL-Cholesterol changes	Serum HDL concentration	Baseline and after 8 weeks
Secondary	Weight change	Body weight of participants	Baseline and after 8 weeks
Secondary	Systolic blood pressure changes	Systolic blood pressure	Baseline and after 8 weeks
Secondary	Diastolic blood pressure changes	Diastolic blood pressure	Baseline and after 8 weeks
Secondary	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
Secondary	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