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The effect of crocin supplementation on glycemic control, inflammatory factors, oxidative stress biomarkers, glomerular and tubular markers in patients with diabetic nephropathy: A randomized controlled clinical trial

Protocol summary

Study aim
Determining the effect of Crocin supplementation on glycemic indexes, inflammatory factors, oxidative stress biomarkers, tubular and glomerular indices in patients with diabetic nephropathy
Design
The present study is a phase 3, parallel-group, randomized controlled clinical trial that will be conducted on 60 patients. The participants will be randomly assigned to the intervention and control groups using a random number table.
Settings and conduct
Patients with diabetic nephropathy referred to the nephrology clinic are invited to participate in this research. After checking the inclusion criteria, 10 cc of blood will be taken from the patients. Patients are divided into two groups (intervention and placebo) and biochemical parameters are measured before treatment and 12 weeks after treatment.Patients, researchers, physicians, and those who evaluate the outcome do not know how the groups were assigned and what intervention each group received.
Participants/Inclusion and exclusion criteria
From the patients with diabetic nephropathy who have visited the Nephrology Clinic of Shahid Beheshti University of Medical Sciences in Kashan, 60 patients will be selected based on the inclusion and exclusion criteria of the study. Patients with moderate hypertension (SBP140-160 mmHg and DBP 90-100 mmHg) and with a GFR more than 60 mL/min, if eligible based on the exclusion criteria (such as no use of antioxidant supplements), will be enrolled in the study.
Intervention groups
In this study, patients with diabetic nephropathy are divided into two groups. Intervention group: crocin tablets; Control group: placebo tablets. Patients in the crocin group will receive crocin supplement and the control group will receive a daily placebo tablet containing starch for 12 weeks.
Main outcome variables
Glycemic indices, inflammatory biomarkers, oxidative stress factors, tubular and glomerular indices.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170611034458N3
Registration date: 2024-07-20, 1403/04/30
Registration timing: registered_while_recruiting

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Alireza Mafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7052
Email address
armafi@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of crocin supplementation on glycemic control, inflammatory factors, oxidative stress biomarkers, glomerular and tubular markers in patients with diabetic nephropathy: A randomized controlled clinical trial
Public title
Effect of crocin supplementation in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic nephropathy aged 40 to 75 years Moderate blood pressure (systolic pressure 140-160 and diastolic pressure 90-100 mm Hg) Absence of urinary tract infection and any other disease that can cause proteinuria Glomerular filtration rate more than 60 milliliters per minute.
Exclusion criteria:
Taking antioxidant supplements from three months before entering the study. Patients who do not want to participate in the study or do not take medication regularly. Taking steroidal immunosuppressive drugs (corticosteroids). Suffering from certain cardiovascular diseases, cancer, inflammatory diseases, autoimmune disorders, or hyper- or hypothyroidism. Taking anticoagulants. Having high blood pressure (systolic pressure above 140 and diastolic pressure above 90 mm Hg). pregnancy Smoking and alcohol use
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with diabetic nephropathy who meet the study entry criteria will be selected in easy manner. Computer-generated random numbers will be used for the random allocation process. Patients will be divided into intervention and control groups using the random numbers. Then, the researcher will select a point by closing their eyes and placing their finger on the generated random numbers. It should be noted that the researcher pre-determines how to read the numbers (e.g., up, down, left, or right). The second assumption is the assignment of numbers to different groups (for example, even numbers for the intervention group and odd numbers for the placebo group). In fact, for each individual, a code generated from random numbers (such as 001, 002, etc.) will be considered, and the even numbers will be assigned to the intervention group and the odd numbers to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, researchers, healthcare personnel (physician), the data collectors, and those who assess the outcomes are unaware of the group assignments and the interventions received by each group. To implement a double-blind design for this study, at the start of the study, a set of containers containing either saffron supplements or placebo will be coded as A and B by a third party (someone other than the researchers). After randomization, the sets of containers coded as A and B containing either crocin supplements or placebo will be provided to both groups of patients. Until the complete collection of the study results, the patient, researcher, physician, and outcome assessor will not have any information about the assigned codes. After the completion of the study, the codes will be unblinded. Therefore, this will be a double-blind study.
Placebo
Used
Assignment
Parallel
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
Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Hezar Jerib St,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.023

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy

Primary outcomes

1

Description
Serum Creatinine
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

2

Description
Blood Urea Nitrogen
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

2

Description
Serum concentrations of insulin
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

3

Description
Homeostatic model assessment for Insulin Resistance Index (HOMA-IR)
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
The HOMA-IR Index is calculated using fasting glucose and fasting insulin levels.

4

Description
Serum concentrations of triglyceride
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

5

Description
HDL-C cholesterol
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

6

Description
Total cholesterol
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

7

Description
LDL cholesterol
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Enzymatic assay kit

8

Description
Evaluation of the serum level of Cystatin-C parameter
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

9

Description
Nitric oxide
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

10

Description
Serum concentrations of high sensitivity c-reactive protein (hs-CRP)
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

11

Description
Serum concentrations of Interleukin 6 (IL-6)
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

12

Description
Serum concentration of Total antioxidant capacity (TAC)
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

13

Description
Malondialdehyde
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Spectrophotometry

14

Description
Glutathione
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
ELISA kit

15

Description
Advanced glycosylation end-products
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Fluorometric method

16

Description
Evaluation of estimated glomerular filtration rate (eGFR)
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Using available formulas

17

Description
Anxiety beck score
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Beck Anxiety Inventory

18

Description
Sleep quality
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Pittsburgh Sleep Quality Index questionnaire

19

Description
Sexual function
Timepoint
Initially (before the intervention) and at the end (12 weeks after the intervention)
Method of measurement
Hurlbert index of sexual desire questionnaire

Intervention groups

1

Description
The intervention group will receive crocin supplement (produced by Sami Saz Company) for 12 weeks. Each tablets contains 30 mg of crocin. The tablets will be provided to the patients in 30-count packages, and the patients will receive a new package monthly. The patients will be instructed to take one tablets per day, after their lunch meal. Patients in the study groups, in addition to the intervention and placebo treatments, will also receive routine treatment which includes the administration of metformin tablets.
Category
Treatment - Other

2

Description
The control group will receive placebo capsules containing starch for 12 weeks. The placebo will be provided by the Sami Saz Company. The tablets will be provided to the patients in 30-count packages, and the patients will receive a new package monthly. The patients will be instructed to take one tablets per day, after their lunch meal. Patients in the study groups, in addition to the intervention and placebo treatments, will also receive routine treatment which includes the administration of metformin tablets.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Alireza soleimani
Street address
Shahid Beheshti Hospital, Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
soleimani_a@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza askari
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
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
Zeinab Mokhtari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
zeinab_mokhtary@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
zeinab_mokhtary@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab Mokhtari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar jarib st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Fax
Email
zeinab_mokhtary@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
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
Potential data on primary and secondary consequences is shareable after making individuals unidentifiable
When the data will become available and for how long
After printing the results
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
If they have an official letter from the relevant university or scientific institute, they are allowed to use the data.
From where data/document is obtainable
Dr. Zeinab Mokhtari, Assistant Professor of Nutritional Sciences, Food Security Research Center, Isfahan University of Medical Sciences E-mail: mokhtari@nutr.mui.ac.ir
What processes are involved for a request to access data/document
Contacting Dr. Zeinab Mokhtari via email
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