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NCT Number: NCT03625856

The Effect of Chlorella Supplementation 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amir Mahdi Hosseini

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorella Vulgaris

Dietary Supplement

Chlorella capsules 1500 mg/day

Other names: Algomed

Placebo

Dietary Supplement

Starch 1500 mg

Primary outcomes

  1. HbA1c changes

    Time frame: Baseline and after 8 weeks

    Serum HbA1c concentration

Secondary outcomes

  1. FBS changes

    Time frame: Baseline and after 8 weeks

    Serum glucose concentration

  2. Insulin sensitivity changes

    Time frame: Baseline and after 8 weeks

    HOMA-IR

  3. Triglyceride changes

    Time frame: Baseline and after 8 weeks

    Serum TG concentration

  4. Total cholesterol changes

    Time frame: Baseline and after 8 weeks

    Serum TC concentration

  5. HDL-Cholesterol changes

    Time frame: Baseline and after 8 weeks

    Serum HDL concentration

  6. Weight change

    Time frame: Baseline and after 8 weeks

    Body weight of participants

  7. Systolic blood pressure changes

    Time frame: Baseline and after 8 weeks

    Systolic blood pressure

  8. Diastolic blood pressure changes

    Time frame: Baseline and after 8 weeks

    Diastolic blood pressure

  9. Anxiety score changes

    Time frame: Baseline and after 8 weeks

    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.

  10. Depression score changes

    Time frame: Baseline and after 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Dr. Behnood Abbasi

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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