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Assessment of the effect of quercetin on glycemic index and inflammatory markers in prediabetes patients: A randomized placebo-controlled clinical trial

Protocol summary

Study aim
Assessment of the effect of quercetin on glycemic index and inflammatory markers in prediabetes patients: A randomized placebo-controlled clinical trial
Design
Randomized clinical trial of placebo group, with parallel groups, double-blind, phase 3 on 70 patients. The www.sealedenvelope.com was used to generate a blocked random allocation sequence.
Settings and conduct
In this randomized clinical trial study, prediabetic patients referred to Ghaem Hospital in Mashhad are randomly assigned to one of the two intervention or placebo groups after obtaining informed consent. Double-blind randomization will be done by packets in the package. Based on a pre-designed checklist, patients in both groups will be evaluated for 12 weeks, with clinical signs, Compliance with lifestyle and possible drug side effects, fasting blood sugar (FBS), hemoglobin A1C, serum insulin, insulin resistance index (HOMA-IR), lipid profile including HDL, LDL and cholesterol, as well as liver enzymes ALT and AST, bilirubin , creatinine, triglyceride, CBC as well as inflammatory markers CRP and IL-6 at the baseline (day 1), and the end-point (end of 12 weeks).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Prediabetic patients, Conscious consent to participate in the study, Aged 18 years and older, Exclusion criteria: Pregnancy and lactation, Diagnosis of Cancer and autoimmune diseases, Dissatisfaction with participating in the study
Intervention groups
In the intervention group, patients take 500 mg quercetin capsule daily for 12 weeks.
Main outcome variables
The level of fasting blood sugar (FBS), serum insulin, as well as the level of CRP and IL-6 expression markers at the beginning and end of the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210531051459N3
Registration date: 2024-08-10, 1403/05/20
Registration timing: prospective

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Mona Kabiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 7403
Email address
kabirimn@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of quercetin on glycemic index and inflammatory markers in prediabetes patients: A randomized placebo-controlled clinical trial
Public title
The effect of quercetin in prediabetes patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with prediabetes with fasting blood sugar (greater than or equal to 100 and less than 125 mg/dL) or increased blood sugar two hours after prescribing glucose (greater than or equal to 140 and less than 200 mg/dL) or hemoglobin A1C range 5.7% to 6.4% Aged 18 years and older Conscious consent to participate in the study
Exclusion criteria:
Pregnancy and lactation consumption of hypoglycemic drugs Consumption of quercetin in the last three months Taking of crocin and curcumin supplementations History of liver and kidney failures and cardiovascular diseases Cancer and autoimmune diseases Dissatisfaction with participating in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type: Block Randomization unit: Individual Randomization tool: www.sealedenvelope.com How to create a random sequence: At www.sealedenvelope.com, the randomization section, after selecting the list, specifies the number of groups, the size of the blocks (4, 6, 8) and the length of the list, and provides the list accordingly. Allocation Concealment: Sealed envelopes Participants are given an envelope according to which they are placed in one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants did not know the type of treatment they received. Also, patient clinicians, physicians, and outcome assessors are unaware of how patients are grouped and use medication or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences, Imam Reza hospital
Street address
Imam Reza Hospital, Imam Reza square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.MUMS.IRH.REC.1402.059

Health conditions studied

1

Description of health condition studied
Prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose

Primary outcomes

1

Description
Fasting blood sugar level (FBS)
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

2

Description
Serum insulin level
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

3

Description
Level of inflammatory marker CRP
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

4

Description
Level of inflammatory marker IL-6
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

Secondary outcomes

1

Description
Level of HbA1C
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

2

Description
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

3

Description
Lipid profile levels including LDL, HDL, cholesterol and triglyceride
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

4

Description
Levels of liver enzymes ALT and AST
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

5

Description
Bilirubin level
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

6

Description
Creatinine level
Timepoint
Beginning of the study and the end of 12 weeks
Method of measurement
Blood sampling and serum isolation

Intervention groups

1

Description
Intervention group: The enrolled patients take one 500 mg herbal quercetin capsule (3,3′,4′,5,7-pentahydroxyflavone) daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: The enrolled patients take one placebo capsule daily for 12 weeks. The placebo capsule contains starch and is similar in appearance, weight and packaging to quercetin capsules.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mona Kabiri
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 7403
Email
Kabirimn@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mona Kabiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 7403
Email
kabirimn@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mona Kabiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 7403
Email
Kabirimn@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mona Kabiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 7403
Email
Kabirimn@mums.ac.ir

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Potential data can be shared after participants are not identified.
When the data will become available and for how long
Access period will be started 9 months after the published results.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The use of data and its analysis is allowed by mentioning the source.
From where data/document is obtainable
It is necessary to send an email to the corresponding author of the article for receiving the data.
What processes are involved for a request to access data/document
The processes that a researcher who requests data goes through will include a letter of request from the person, a letter of request from the center or university of origin, and acceptance of the destination university to receive the information.
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