Protocol summary
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Study aim
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The evaluation of The effect of garlic powder supplementation on Metabolic Syndrome components, Fatty liver index, Intestinal function and Appetite Control in military patients with metabolic syndrome referred to Taleghani Hospital of Urmia
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Design
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Clinical trial with control group, parallel groups, double blind, randomised with 90 people sample size.
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Settings and conduct
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This study was performed as randomized, parallel controlled clinical trial on 90 patients with Metabolic Syndrome. In this study, while receiving written informed consent from patients, participants were blinded to receiving drugs and placebo.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age more than 18 y; subjects with metabolic syndrome according to ATP III guideline. Exclusion criteria: kidney disease; type 1 and 2 diabetes; psychiatric disorder; cancers; pregnancy and lactation; using blood pressure lower, blood sugar lower and anticoagulant drugs; allergy to garlic
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Intervention groups
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The intervention group: consume 4 tablets of 400 miligrams per day garlic The control group: consume 4 tablets of 400 miligrams per day placebo
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Main outcome variables
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body composition; insulin resistance; lipid profile; systolic and diastolic blood pressure; intestinal function; Quantity of appetite; fatty liver index
General information
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Reason for update
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We added secondary outcomes.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180201038585N6
Registration date:
2020-02-22, 1398/12/03
Registration timing:
retrospective
Last update:
2021-11-24, 1400/09/03
Update count:
2
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Registration date
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2020-02-22, 1398/12/03
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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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2019-11-20, 1398/08/29
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Expected recruitment end date
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2020-02-18, 1398/11/29
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Actual recruitment start date
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2019-11-20, 1398/08/29
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Actual recruitment end date
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2020-02-18, 1398/11/29
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Trial completion date
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2020-05-19, 1399/02/30
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Scientific title
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The effect of garlic powder supplementation on Metabolic Syndrome components, Fatty liver index, Intestinal function and Appetite Control in patients with metabolic syndrome
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Public title
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Effect of garlic in improvement of 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:
Age more than 18 y
Diagnosis of metabolic syndrome
Exclusion criteria:
Kidney disease
Cardiovascular disease
Type 1 and 2 diabetes
Cancers
Using blood pressure lower drugs
Using blood sugar lower drugs
Using anticoagulant drugs
Psychiatric disorders
Pregnancy and Lactation
Allergy to garlic
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Age
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From 18 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization lists were computer-generated by a statistician, then, participants assigned to the groups of the study. A trained person, randomly allocated and assigned the participants to study groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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intervention and randomization were performed through a random allocation list by a member of the research team as the only blinded individual to the assignment. Other members of the research team (including team leader and study coordinator), as well as all participants, were randomly assigned to groups and intervention and remained blind until the end of the
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Placebo
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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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2019-07-09, 1398/04/18
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Ethics committee reference number
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IR.BMSU.REC.1398.120
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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E00-E90
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ICD-10 code description
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Endocrine, nutritional and metabolic diseases
Primary outcomes
1
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Description
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HDL cholesterol
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Enzymatic method, mg/dl
Secondary outcomes
1
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Description
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Weight
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Scale, kg
2
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Description
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Body mass index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Weight(kg)\[height(m)]2 , kg\m2
3
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Description
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Waist Circumference
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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BIA, cm
4
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Description
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Body fat percent
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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BIA
5
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Description
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Triglyceride
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Enzymatic method, mg/dl
6
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Description
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LDL cholesterol
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Enzymatic method, mg/dl
7
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Description
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Total cholesterol
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Enzymatic method, mg/dl
8
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Description
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Systolic blood pressure
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Mercury sphygmomanometer, mmHg
9
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Description
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Diastolic blood pressure
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Mercury sphygmomanometer, mmHg
10
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Description
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Fatty liver index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
11
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Description
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Quantity of appetite
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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VAS questionnaire
12
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Description
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Intestinal function
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Bristol stool questionaire
13
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Description
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Fasting blood sugar
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Enzymatic method, IU\ Lit
14
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Description
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Serum insulin
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Timepoint
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at the beginning of the study (before intervention), and 12 weeks after intervention
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Method of measurement
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Radioimmunoassay
15
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Description
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HOMA-IR
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Timepoint
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at the beginning of the study (before intervention), and 12 weeks after intervention
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Method of measurement
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Formula
16
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Description
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Cardiometabolic index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
17
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Description
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Atherogenic index of plasma
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
18
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Description
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Atherogenic coefficient
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
19
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Description
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Castelli risk index I
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
20
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Description
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Castelli risk index II
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
21
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Description
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Visceral adiposity index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
22
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Description
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Lipid aaccumulation product
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
23
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Description
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waist to height ratio
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
24
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Description
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ABSI Index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
25
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Description
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BRI index
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Timepoint
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at the beginning of the study (before intervention), 6 and 12 weeks after intervention
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Method of measurement
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Formula
Intervention groups
1
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Description
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Intervention group: The intervention group will be consume 4 tablets of 400 miligrams per day garlic.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months.
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Category
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Placebo
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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Bagheiat-allah 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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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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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable