Type 2 Diabetes MellitusNCT03625856
The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus
A study testing Chlorella Vulgaris in people with Type 2 Diabetes Mellitus, run by Dr. Behnood Abbasi at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Chlorella Vulgaris
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- 30 Nov 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Chlorella Vulgaris, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorella VulgarisDietary supplement
Also called Algomed
Chlorella capsules 1500 mg/day
PlaceboDietary supplement
Starch 1500 mg
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 1500 mg Chlorella Vulgaris capsule Receives: Dietary Supplement: Chlorella Vulgaris |
| Control | Placebo comparator | 1500 mg placebo (starch) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c changes
Serum HbA1c concentration
Measured: Baseline and after 8 weeks
Secondary outcomes (10)
FBS changes
Serum glucose concentration
Measured: Baseline and after 8 weeks
Insulin sensitivity changes
HOMA-IR
Measured: Baseline and after 8 weeks
Triglyceride changes
Serum TG concentration
Measured: Baseline and after 8 weeks
Total cholesterol changes
Serum TC concentration
Measured: Baseline and after 8 weeks
HDL-Cholesterol changes
Serum HDL concentration
Measured: Baseline and after 8 weeks
Weight change
Body weight of participants
Measured: Baseline and after 8 weeks
Systolic blood pressure changes
Systolic blood pressure
Measured: Baseline and after 8 weeks
Diastolic blood pressure changes
Diastolic blood pressure
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start30 Nov 2018
- Primary completion1 May 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly allocated into two groups; Chlorella and placebo groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behnood Abbasi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Behnood Abbasi, Islamic Azad University, Sanandaj
- Investigators
- Ali Keshavarz, Ph.D., Principal investigator, Islamic Azad University,Science and Research Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625856
- Sponsor's protocol ID
- IR.TUMS.EMRI.REC.1396.00195
- Status last verified
- Jan 2020
- First submitted
- 8 Aug 2018
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorella Vulgaris Supplementation on Glycemic Control, Lipid Profile and Anthropometric Measurements on Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03625856
- Acronym / sponsor ID
- IR.TUMS.EMRI.REC.1396.00195
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dr. Behnood AbbasiUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated into two groups; Chlorella and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Chlorella Vulgaris1500 mg Chlorella Vulgaris capsule |
| Control | Placebo comparator | Dietary Supplement: Placebo1500 mg placebo (starch) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorella VulgarisAlso: AlgomedChlorella capsules 1500 mg/day | Dietary supplement | Intervention |
| PlaceboStarch 1500 mg | Dietary supplement | Control |
Primary outcome
HbA1c changes
Time frame: Baseline and after 8 weeks
Serum HbA1c concentration
10 secondary outcomes
FBS changes
Time frame: Baseline and after 8 weeks
Insulin sensitivity changes
Time frame: Baseline and after 8 weeks
Triglyceride changes
Time frame: Baseline and after 8 weeks
Total cholesterol changes
Time frame: Baseline and after 8 weeks
HDL-Cholesterol changes
Time frame: Baseline and after 8 weeks
Weight change
Time frame: Baseline and after 8 weeks
Systolic blood pressure changes
Time frame: Baseline and after 8 weeks
Diastolic blood pressure changes
Time frame: Baseline and after 8 weeks
Anxiety score changes
Time frame: Baseline and after 8 weeks
Depression score changes
Time frame: Baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keshavarz, Ph.D. principal investigator
Islamic Azad University,Science and Research Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorella Vulgaris in people with Type 2 Diabetes Mellitus, run by Dr. Behnood Abbasi at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c changes (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.