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

NCT03625856 | Completed DMC

• 1 other identifier: IR.TUMS.EMRI.REC.1396.00195
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c changes

  Serum HbA1c concentration

  Baseline and after 8 weeks

Secondary Outcomes (10)

• FBS changes

  Baseline and after 8 weeks

• Insulin sensitivity changes

  Baseline and after 8 weeks

• Triglyceride changes

  Baseline and after 8 weeks

• Total cholesterol changes

  Baseline and after 8 weeks

• HDL-Cholesterol changes

  Baseline and after 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

1500 mg Chlorella Vulgaris capsule

Dietary Supplement: Chlorella Vulgaris

Control

PLACEBO COMPARATOR

1500 mg placebo (starch)

Dietary Supplement: Placebo

Interventions

Chlorella Vulgaris DIETARY_SUPPLEMENT

Chlorella capsules 1500 mg/day

Also known as: Algomed

Intervention

Placebo DIETARY_SUPPLEMENT

Starch 1500 mg

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behnood Abbasi: lead

Study Sites (1)

Amir Mahdi Hosseini

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ali Keshavarz, Ph.D.

  Islamic Azad University,Science and Research Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study is a double-blind, randomized controlled trial. Subjects will be randomly allocated into two groups and each one will receive the supplement (Chlorella Vulgaris) or placebo for 8 weeks. To prevent selection bias, the study participants, investigators and the laboratory staff will be all blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Subjects will be randomly allocated into two groups; Chlorella and placebo groups.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: November 30, 2018
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

IR (1)