The effect of Rhus Coriaria (Sumac) supplementation on inflammatory status, insulin resistance and antioxidant status in patients with metabolic syndrome: a randomized, triple-blind crossover clinical intervention
The effect of sumac supplementation on inflammatory status, insulin resistance and antioxidant status in patients with metabolic syndrome: A randomized, triple-blind crossover clinical intervention
Design
A randomized, triple-blind crossover clinical intervention
Settings and conduct
Sedigheh Tahereh Research Center Random allocation method Cross-over triple blind clinical intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Agreement to participate in the study, adults aged 20-55 years with metabolic syndrome;
Exclusion criteria: illness, taking medication and supplements, pregnancy and lactation, following a special diet
Intervention groups
Intervention group: 20 participants will consume sumac capsules (each capsule: 500 mg, 2 capsules/day) during 4 weeks.;
Control group:20 participants will consume Lactose capsules (each capsule: 500 mg, 2 capsules/day) during 4 weeks.
Main outcome variables
Inflammation status, Insulin resistance, Antioxidant status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200106046022N2
Registration date:2021-07-22, 1400/04/31
Registration timing:prospective
Last update:2021-07-22, 1400/04/31
Update count:0
Registration date
2021-07-22, 1400/04/31
Registrant information
Name
Parvane Saneei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3159
Email address
mirenayatfatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rhus Coriaria (Sumac) supplementation on inflammatory status, insulin resistance and antioxidant status in patients with metabolic syndrome: a randomized, triple-blind crossover clinical intervention
Public title
Effects of sumac on inflammatory status, insulin resistance and antioxidant status in 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
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
An unaware person that is not involved in study, will perform block randomization using the website of” WWW.randomization.com” and based on the code assigned to each participants. Such that, subjects will be randomly divided in two groups of intervention and control 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
Isfahan University of Medical Sciences, Hezar Jerib Ave
At the beginning and end of each Six-week intervention
Method of measurement
Existing commercial kits
2
Description
Antioxidant status (MDA,CTL,SOD)
Timepoint
At the beginning and end of each Six-week intervention
Method of measurement
En Existing commercial kits
3
Description
Inflammation status (CRP)
Timepoint
At the beginning and end of each Six-week intervention
Method of measurement
Existing commercial kits
Secondary outcomes
1
Description
Waist Circumference
Timepoint
At the beginning and end of each intervention period
Method of measurement
Meters irreversible
2
Description
Weight
Timepoint
At the beginning and end of each intervention period
Method of measurement
Digital Balance
3
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
Sedigheh Tahereh Research Center, Khorram Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3158
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
8174673461
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