Protocol summary
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Study aim
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Determination of the Effects of Coconut Oil on Metabolic Syndrome Indices in Adults
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Design
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A randomized, controlled, clinical, parallel trial (with a 22-person coconut oil group and a control group (44 patients in total)).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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1.The group taking coconut oil 2. Control group (receiving their usual consumption of oil)
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Main outcome variables
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blood pressure , Waist circumference, Serum lipid profile, Serum glucose, serum Asymmetric dimethyl arginine
General information
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Reason for update
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Adding and evaluating new variables was considered due to receiving more financial resources and in line with the registered trial.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-01-10, 1398/10/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-22, 1398/04/31
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Expected recruitment end date
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2019-12-21, 1398/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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To assess the effects of coconut oil consumption on metabolic syndrome indices in adults
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Public title
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The effects of coconut oil in metabolic syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-10, 1398/03/20
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.242
Health conditions studied
1
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Description of health condition studied
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metabolic syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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metabolic syndrome
Primary outcomes
1
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Description
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Blood pressure
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Digital barometer
2
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Description
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serum Fasting blood glucose level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Enzymatic Kit
3
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Description
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serum triglyceride level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Enzymatic Kit
4
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Description
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serum HDL-C level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Enzymatic Kit
5
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Description
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serum Asymmetric D-methyl arginine level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Eliza kit
6
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Description
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Waist circumference
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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observation
7
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Description
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serum brain derived neurotrophic factor level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Eliza kit
Secondary outcomes
1
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Description
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Body composition analysis
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Bio-electrical impedance analysis
2
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Description
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Serum lipid profile
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Enzymatic Kit
3
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Description
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Serum insulin level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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Eliza kit
4
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Description
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serum malondialdehyde level
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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MDA assay Kit (colorimetrically or fluorometrically)
5
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Description
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serum total antioxidant capacity
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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TAC assay Kit (photometrically)
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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Control group: People in this group will continue to receive their usual diet, especially in terms of type and amount of oil consumed.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available