The effect of sumac and cinnamon on lipid profile and quality of life in patients with cardiovascular diseases, a randomized double-blind controlled clinical trial.
Determining the effect of sumac and cinnamon on lipid profile and quality of life in patients with cardiovascular diseases.
Design
A randomized clinical trial with double-blind design and parallel groups.
Settings and conduct
75 patients in Imam Sajjad hospital in Yasouj will be selected by the entry criteria and will be divided into 3 groups. Then, based on the list, the nurse or nutrition expert or secretary in the department will give the patients a number and a type of capsule specified for that number, and will deliver this assignment and numbering to the nutrition group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with MI between 20 and 75 years old with a BMI above 25
non-entry criteria: People who are allergic to sumac and cinnamon and suffering from systemic diseases such as liver, kidney, gout, rheumatoid arthritis and acute or chronic kidney failure.
Intervention groups
First intervention group: patients receiving 2 grams of sumac for 8 weeks
Second intervention group: patients receiving 2 grams of sumac and cinnamon in combination for 8 weeks
Main outcome variables
Low density lipoprotein, high density lipoprotein, very low density lipoprotein, triglyceride, cholesterol, pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150711023153N5
Registration date:2023-12-06, 1402/09/15
Registration timing:prospective
Last update:2023-12-06, 1402/09/15
Update count:0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Seyed Bahman Panahande
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 3505
Email address
panahande-b@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sumac and cinnamon on lipid profile and quality of life in patients with cardiovascular diseases, a randomized double-blind controlled clinical trial.
Public title
The effect of sumac and cinnamon on cardiovascular patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Completing and signing the informed consent form.
Age between 20-75 years
Patients hospitalized in the cardiac intensive care unit who have MI (myocardial infarction) based on a definitive diagnosis.
Type 2 diabetes mellitus diagnosed by a doctor
Body mass index (BMI)>25
Familiarity with Persian language and the ability to read and write
Exclusion criteria:
Pregnant and lactating people or people with mental illnesses, as well as patients with stomach ulcers or digestive disorders or other disorders affecting food metabolism.
hypothyroidism or hyperthyroidism and any systemic disease (including liver, kidney, gout, rheumatoid arthritis and acute or chronic kidney failure)
Allergy to sumac or cinnamon
Users of psychotropic drugs, including antidepressants, anti-psychotics, anti-anxiety drugs
Heart failure in stage IV
Acute infections at the time of study entry
Obstructive pulmonary diseases
Treatment with sex hormones
Use of medication interfering with the study
Participation in another clinical study in the last 3 months
People with any problems in understanding and filling the consent form
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be stratify by Block Random sampling based on age and sex in one of 12 blocks of 6 and 7 people and by random numbers from a website (Randomization.com) in one of three Sumac or Sumac and cinnamon or placebo groups, this list is in the hands of the group's secretary and Who Does not play a role in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, health personnel, main researchers, as well as those responsible for data collection and analysis will be unaware of the intervention and placebo groups until the end of the study. The intervention consists of placebo or sumac or sumac and cinnamon in special capsules that are completely similar in terms of shape and color and are placed in numbered packages, and the contents of these numbers will be kept in closed envelopes in the faculty, and the contents will be preserved until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Yasuj University of Medical Science
Street address
Shahid Motahari Boulevard, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.YUMS.REC.1402.040
Health conditions studied
1
Description of health condition studied
Cardiovascular diseases (CVDs)
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
low-density lipoprotein
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods
2
Description
high-density lipoprotein
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods - Elisa Kit
3
Description
very-low density lipoprotein
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods
4
Description
Triglyceride
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods - Elisa Kit
5
Description
Total Cholesterol
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods - Elisa Kit
6
Description
Life Quality
Timepoint
At the beginning and end of the intervention period
Method of measurement
World Health Organization quality of life questionnaire bref
7
Description
Pain
Timepoint
At the beginning and end of the intervention period
Method of measurement
Mcgill pain questionnarie
Secondary outcomes
1
Description
Interleukin-6
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods
2
Description
high sensitive C reactive protein (hs-CRP)
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods
3
Description
Complete blood count
Timepoint
At the beginning and end of the intervention period
Method of measurement
Laboratory methods
Intervention groups
1
Description
First intervention group: patients receiving 2 grams of sumac daily in 2 doses (1 gram capsules containing sumac).
Category
N/A
2
Description
Second intervention group: patients receiving daily 1 gram of sumac and 1 gram of cinnamon in 2 doses (1 gram capsules containing 0.5 grams of sumac and 0.5 grams of cinnamon)
Category
N/A
3
Description
Control group: patients receiving 1 gram placebo capsules (Cellulose) on 2 occasions
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad hospital in Yasuj city
Full name of responsible person
Majid Ahmadi
Street address
Yasuj, road to Sajjad Hospital, Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3344 4079
Email
majidahmadi1385@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini Mutlaq
Street address
Yasouj- Shahid Motahari Boulevard- Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3344 4079
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ashkan Golmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Chaharbagh Payin, 33 Alley, No. 5
City
Isfahan
Province
Isfehan
Postal code
8148635756
Phone
+98 31 3448 5149
Email
ashkan.gol79@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Bahman Panahande
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Hossein Square - Golestan 15, Faculty of Health and Nutrition
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Phone
+98 74 3322 5519
Email
panahande.b@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Bahman Panahande
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Hossein Square - Golestan 15, Faculty of Health and Nutrition
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Phone
+98 74 3322 3505
Email
panahande.b@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on primary variables will be shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will only be available to researchers working in academic and scientific institutions
From where data/document is obtainable
Seyed Bahman Panahande, Yasuj University of Medical Sciences, Yasuj, Iran. Email: panahande.b@gmail.com P.O. Box 7591741417, Tel:+98- 074-33346078, Fax:+98- 074-33346079,
What processes are involved for a request to access data/document
After receiving approval from Yasuj University of Medical Sciences (one week to one month), the data will be sent to the applicant