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General information
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Adding and evaluating new variables was considered due to receiving more financial resources and in line with the registered trial.
Adding and evaluating new variables was considered due to receiving more financial resources and in line with the registered trial.
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افزودن و بررسی متغیرهای جدید با توجه به دریافت منابع مالی بیشتر و در راستای کارآزمایی ثبت شده مورد نظر قرار گرفت.
افزودن و بررسی متغیرهای جدید با توجه به دریافت منابع مالی بیشتر و در راستای کارآزمایی ثبت شده مورد نظر قرار گرفت.
Primary outcomes
#1
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serum brain derived neurotrophic factor level
serum brain derived neurotrophic factor level
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سطح سرمی فاکتور نوروتروفیک مشتق شده از مغز
سطح سرمی فاکتور نوروتروفیک مشتق شده از مغز
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Before and after 4 weeks of intervention
Before and after 4 weeks of intervention
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قبل و بعد از 4 هفته مکمل یاری
قبل و بعد از 4 هفته مکمل یاری
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Eliza kit
Eliza kit
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کیت الایزا
کیت الایزا
Secondary outcomes
#1
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Serum insulin level
Serum insulin level
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سطح انسولین سرمی
سطح انسولین سرمی
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Before and after 4 weeks of intervention
Before and after 4 weeks of intervention
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قبل و بعد از 4 هفته مکمل یاری
قبل و بعد از 4 هفته مکمل یاری
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Eliza kit
Eliza kit
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کیت الایزا
کیت الایزا
#2
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serum malondialdehyde level
serum malondialdehyde level
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سطح مالون دی آلدهید سرمی
سطح مالون دی آلدهید سرمی
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Before and after 4 weeks of intervention
Before and after 4 weeks of intervention
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قبل و بعد از 4 هفته مکمل یاری
قبل و بعد از 4 هفته مکمل یاری
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MDA assay Kit (colorimetrically or fluorometrically)
MDA assay Kit (colorimetrically or fluorometrically)
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کیت سنجش مالون دی آلدهید (کالریمتری یا فلوریمتری)
کیت سنجش مالون دی آلدهید (کالریمتری یا فلوریمتری)
#3
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serum total antioxidant capacity
serum total antioxidant capacity
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ظرفیت آنتی اکسیدانی تام سرم
ظرفیت آنتی اکسیدانی تام سرم
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Before and after 4 weeks of intervention
Before and after 4 weeks of intervention
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قبل و بعد از 4 هفته مکمل یاری
قبل و بعد از 4 هفته مکمل یاری
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TAC assay Kit (photometrically)
TAC assay Kit (photometrically)
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کیت سنجش ظرفیت آنتی اکسیدانی تام (فوتومتری)
کیت سنجش ظرفیت آنتی اکسیدانی تام (فوتومتری)
Protocol summary
Study aim
Determination of the Effects of Coconut Oil on Metabolic Syndrome Indices in Adults
Design
A randomized, controlled, clinical, parallel trial (with a 22-person coconut oil group and a control group (44 patients in total)).
Settings and conduct
Forty-five men and women between the ages of 20 and 50 with metabolic syndrome will be selected based on NCEP ATP III criteria from persons have come to the Tehran Heart Center. Anthropometric assessments and body composition and blood pressure are measured and a demographic questionnaire is completed. and 3 days recall will be taken from the patients. Blood will be taken from patients for biochemical tests (lipid profile, serum glucose, ALT, AST and asymmetric dimethyl arginine), all of which will be administered again after 4 weeks of Consumption of coconut oil 30 ml daily by coconut oil group , for both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Men and women between the ages of 20 and 50 with a diagnosis of metabolic syndrome who are willing to participate in the study.
• Exclusion criteria:
History of any type of medical or surgical disease, alcohol consumption, history of intolerance to coconut oil, pregnancy or breastfeeding, smoking or any type of industrial and traditional drug use, consumption
Any drug or dietary supplement that affects metabolic syndrome indices,
To follow any particular diet or weight loss program, changes in the last three months, and professional exercise
Intervention groups
1.The group taking coconut oil 2. Control group (receiving their usual consumption of oil)
Adding and evaluating new variables was considered due to receiving more financial resources and in line with the registered trial.
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015536N11
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2021-04-19, 1400/01/30
Update count:1
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
To assess the effects of coconut oil consumption on metabolic syndrome indices in adults
Public title
The effects of coconut oil in metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 50 years old men and women diagnosed as metabolic syndrome Giving informed consent for participation in the study
Exclusion criteria:
The history of any type of medical or surgical disease, drinking alcohol, history of coconut oil intolerance, pregnancy or breastfeeding, smoking or any type of drug, the use of any drug or supplement that affects metabolic syndrome indices. , Compliance with a particular diet or weight loss program, changes in the last three months and professional exercise, a patient's unwillingness to continue to study, hypersensitivity or intolerance to the consumption of coconut oil
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to receive coconut oil and control group. The randomized assignment of patients to the two groups will be utilized by a Stratified blocked randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.TUMS.VCR.REC.1398.242
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
metabolic syndrome
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Digital barometer
2
Description
serum Fasting blood glucose level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Enzymatic Kit
3
Description
serum triglyceride level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Enzymatic Kit
4
Description
serum HDL-C level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Enzymatic Kit
5
Description
serum Asymmetric D-methyl arginine level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Eliza kit
6
Description
Waist circumference
Timepoint
Before and after 4 weeks of intervention
Method of measurement
observation
7
Description
serum brain derived neurotrophic factor level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Eliza kit
Secondary outcomes
1
Description
Body composition analysis
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Bio-electrical impedance analysis
2
Description
Serum lipid profile
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Enzymatic Kit
3
Description
Serum insulin level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
Eliza kit
4
Description
serum malondialdehyde level
Timepoint
Before and after 4 weeks of intervention
Method of measurement
MDA assay Kit (colorimetrically or fluorometrically)
5
Description
serum total antioxidant capacity
Timepoint
Before and after 4 weeks of intervention
Method of measurement
TAC assay Kit (photometrically)
Intervention groups
1
Description
Intervention group: Daily intake of 30 ml of coconut oil in the preparation of food or cold as an alternative to the portion of the oil intake
Category
Treatment - Other
2
Description
Control group: People in this group will continue to receive their usual diet, especially in terms of type and amount of oil consumed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center hospital
Full name of responsible person
Ali vasheghani farahani
Street address
North Kargar-Ave, Jalal Al Ahmad Highway, Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
JTHC@TUMS.AC.IR
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth floor, Central Organization of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?