The effects of Crocin supplementation on metabolic parameters, systemic inflammation and AMP- activated protein kinase, TNF-α and NF-Kβ in patients with type 2 diabetes.
The aim of this double-blind randomized clinical trial is to determine the effects of Crocin supplementation on metabolic parameters, systemic inflammation and AMP- activated protein kinase, Tumor Necrosis Factore-α and Nuclear Factor-Kappa β in patients with type 2 diabetes (T2DM).
Design
This study is a double-blind, randomized controlled clinical trial with two parallel groups. 50 patients will be randomly assigned into Crocin and control group.
Settings and conduct
Patients with type 2 diabetes referring to the Diabetes Clinic of Imam-Hossein Hospital will be invited to participate. After assessing the entrance criteria, 10 cc blood samples are taken. The food recall and physical activity questionnaire is completed. Anthropometric measurements and blood pressure are taken. Supplements are given to patients for a month. For double-blind implementation(patients and investigators), all boxes of supplements by a third party is coded as A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 30-70 years old; Body mass index 18.5-30; clinical diagnosis of T2DM (for at least one year);
Non-inclusion criteria: having liver, kidney, inflammatory and pulmonary diseases; alcohol-drug abuse; pregnancy and lactation; insulin injection.
Intervention groups
Intervention group :Crocin tablet; Control group: placebo tablet.
Patients in the Crocin group will receive, for 12 weeks, two tablets of Crocina (Samisaz Company) per day, each containing 15 mg of Crocin. Patients in the control group will receive 2 tablets of placebo containing starch per day.
Main outcome variables
Serum concentrations of Glucose; Insulin; Insulin resistance index (HOMA-IR); Lipid profile; malondialdehyde; Total oxidant capacity; Total anti-oxidant capacity; High sensitivity c-reactive protein; Hemoglobin A1C levels; Interlukin-6; nuclear factor kappa-Β; Tumor necrosis factor-a; AMPK.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170408033308N2
Registration date:2019-08-13, 1398/05/22
Registration timing:registered_while_recruiting
Last update:2019-08-13, 1398/05/22
Update count:1
Registration date
2019-08-13, 1398/05/22
Registrant information
Name
Vahideh behrouz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 0380
Email address
vh.behrouz@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Crocin supplementation on metabolic parameters, systemic inflammation and AMP- activated protein kinase, TNF-α and NF-Kβ in patients with type 2 diabetes.
Public title
Effects of Crocin in Treatment of Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 30-70 years old
Clinical diagnosis of type 2 diabetes (for at least 1 year)
Body mass index (BMI) 18.5-30 kg/m2
Exclusion criteria:
having liver, kidney, inflammatory and pulmonary diseases;
alcohol-drug abuse;
pregnancy and lactation;
insulin injection.
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients on the basis of age and sex are categorized and are randomly assigned to the Crocin or placebo group. To random allocation, a Stratified Blocked Randomization method is used. After specifying blocks of size 4 and allocating numbers to each block, a random number table is used to determine the treatment assignment list. Randomization is concealed in sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing crocin or placebo by a third party (someone other than the researchers) is coded as A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti medical university
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.SBMU.nnftri.Rec.1398.009
Health conditions studied
1
Description of health condition studied
Patients with type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
2
Description
Serum concentrations of insulin
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
3
Description
Hemoglobin A1C levels
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
4
Description
Serum concentrations of malondialdehyde (MDA)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
5
Description
Concentrations of nuclear factor kappa-Β in peripheral blood mononuclear cells
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
6
Description
Serum concentrations of high sensitivity c-reactive protein (hs-CRP)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
7
Description
Serum concentration of Interleukin 6
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
8
Description
Concentrations of tumor necrosis factor alpha in peripheral blood mononuclear cells
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
9
Description
Concentrations of AMP-activated protein kinase in peripheral blood mononuclear cells
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
10
Description
Serum concentrations of triglyceride
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
11
Description
Serum concentrations of total cholesterol
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
12
Description
Serum concentrations of High-density lipoprotein cholesterol (HDL-C)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
13
Description
Serum concentrations of Low-density lipoprotein cholesterol (LDL-C)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic assay kit
Secondary outcomes
1
Description
Serum concentration of Total oxidant capacity (TOC)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
2
Description
Serum concentration of Total anti-oxidant capacity (TAC)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
Intervention groups
1
Description
Intervention group: Crocin supplementation: they will receive, for 12 weeks, two tablets of Crocina (Samisaz Company) per day, each containing 15 mg of crocin.
Category
Treatment - Other
2
Description
Control group: they will receive 2 tablets of placebo containing starch (Samisaz Company) per day for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Meghdad Sedaghat
Street address
Emam Hossein Hosp. - Madani St.
City
Tehran
Province
Tehran
Postal code
7742595633
Phone
+98 21 7343 0045
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Esmat Naseri
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
Nasseri_esm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vahideh Behrouz
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
Vahideh.behrouz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golbon Sohrab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
golbonsohrab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vahideh Behrouz
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
vahideh.behrouz@gmail.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