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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Chlorella Vulgaris; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Amir Mahdi Hosseini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 1500 mg Chlorella Vulgaris capsule	Dietary supplement: Chlorella Vulgaris; Chlorella capsules 1500 mg/day; Other Names: Algomed
Placebo Comparator: Control; 1500 mg placebo (starch)	Dietary supplement: Placebo; Starch 1500 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Behnood Abbasi
• Investigators: Principal Investigator: Ali Keshavarz, Ph.D., Islamic Azad University,Science and Research Branch

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IR.TUMS.EMRI.REC.1396.00195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No