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

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ClinicalTrials.gov Identifier: NCT03625856
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Behnood Abbasi, Islamic Azad University, Tehran

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Chlorella Vulgaris Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomly allocated into two groups; Chlorella and placebo groups.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Effect of Chlorella Vulgaris Supplementation on Glycemic Control, Lipid Profile and Anthropometric Measurements on Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
1500 mg Chlorella Vulgaris capsule
Dietary Supplement: Chlorella Vulgaris
Chlorella capsules 1500 mg/day
Other Name: Algomed

Placebo Comparator: Control
1500 mg placebo (starch)
Dietary Supplement: Placebo
Starch 1500 mg




Primary Outcome Measures :
  1. HbA1c changes [ Time Frame: Baseline and after 8 weeks ]
    Serum HbA1c concentration


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625856


Locations
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Iran, Islamic Republic of
Amir Mahdi Hosseini
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Dr. Behnood Abbasi
Investigators
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Principal Investigator: Ali Keshavarz, Ph.D. Islamic Azad University,Science and Research Branch
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Responsible Party: Dr. Behnood Abbasi, Clinical Professor, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT03625856    
Other Study ID Numbers: IR.TUMS.EMRI.REC.1396.00195
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases