Determination and comparison of anthropometric indices (weight, height, waist circumference, BMI) in the intervention and placebo groups at the beginning and end of each intervention period
Determination and comparison of fasting blood sugar (FBS) in the intervention and placebo groups at the beginning and end of each intervention period
Determination and comparison of lipid profile (HDL, LDL, TG, TC) between the two intervention and placebo groups at the beginning and end of each intervention period
Design
Intervention group of 20 persons
Intervention: 500 mg Sumac capsule
Control group of 20 people
Intervention: 500 mg lactose capsule
Settings and conduct
Sedigheh Tahereh Research Center
Random allocation method
Cross-sectional triple blind clinical intervention
Participants/Inclusion and exclusion criteria
inclusion criteria:
Willingness to participate in the study
Adults 20-55 years old
Metabolic syndrome
Not inclusion criteria:
Having the disease, taking medication and supplements, pregnancy and lactation, following a specific diet
Exclusion criteria:
Not willing to continue cooperation
Observe the effects of supplementation
Create any non-login condition
Intervention groups
Intervention group of 20 persons
Intervention: 500 mg Sumac capsule
Control group of 20 people
Intervention: 500 mg lactose capsule
Effects of Rhus Coriaria(Sumac) supplementation on indicators of metabolic syndrome in adult with metabolic syndrome
Public title
Effects of sumac on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Adults 20-55 years old
Metabolic syndrome based on modified ATPIII criteria
Exclusion criteria:
Having cardiovascular, liver, kidney, thyroid and diabetes diseases
Pregnancy and lactation
Follow a special diet
Use of drugs that affect appetite, blood pressure, inflammation, fat metabolism and carbohydrates
Use of multivitamin-mineral supplements, fatty acids and herbal remedies
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
4
Fasting blood samples to evaluate glucose and lipid profiles
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups A and B by the random blocking method with a 1: 1 allocation ratio. The preparation of sumac and placebo capsules with codes A and B will be determined by a person not involved in sampling and data collection and analysis and researchers don't know how to distribute it. In each intervention period, group A will be given code A capsules and group B will be given code B capsules.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, Sumac and Lactosehr II will be replaced in single-color and uniform 500 mg capsules. Participants, researchers and statisticians will not be aware of the type of capsules.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Tehran, Qods Town (West), between South Flamak and Zarafshan, Iran Sima St. - Central Office of Ministry of Health and Medical Education, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2020-03-08, 1398/12/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.746
Health conditions studied
1
Description of health condition studied
metabolic syndrom
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning and end of each Six-week intervention
Method of measurement
Existing commercial kits
Secondary outcomes
1
Description
Triglyceride
Timepoint
At the beginning and end of each intervention period
Method of measurement
Existing commercial kits
2
Description
High density Lipoprotein Cholesterol
Timepoint
At the beginning and end of each intervention period
Method of measurement
Existing commercial kits
3
Description
Blood pressure
Timepoint
At the beginning and end of each intervention period
Method of measurement
Barometer
4
Description
Waist size
Timepoint
At the beginning and end of each intervention period
Method of measurement
Meters irreversible
5
Description
Weight
Timepoint
At the beginning and end of each intervention period
Method of measurement
ِDigital Balance
6
Description
BMI
Timepoint
At the beginning and end of each intervention period
Method of measurement
Divide the weight by the square of the height
Intervention groups
1
Description
Intervention group: 500 mg capsules of sumac daily, two with food for 6 weeks in the first period of the intervention. In the second period of the intervention of this group, they are in the control group. The capsules are filled with sumac powder powdered by the researcher due to the reduction of counterfeits.
Category
Treatment - Drugs
2
Description
Control group: Lactose 500 mg capsules daily with food for 6 weeks in the first period of the intervention. In the second period of the intervention, this group is in the intervention group. The capsules are filled by the researcher with lactose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedigheh Tahereh Research Center
Full name of responsible person
Saneei Parvane
Street address
School of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3668 8487
Email
saneeip@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mokhtari Zeinab
Street address
School of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3668 1378
Email
zeinab_mokhtari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvane Saneei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition, Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168913868
Phone
+98 31 3792 3159
Email
saneeip@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saneei Parvane
Position
Asisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition, Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168913868
Phone
+98 31 3792 3159
Email
saneeip@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saneei Parvane
Position
Asisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition, Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168913868
Phone
+98 31 3792 3159
Email
saneeip@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available