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The effect of Resveratrol on some biochemical and hormonal factors in university staff

Protocol summary

Study aim
The effect of Resveratrol on some biochemical and hormonal factors in university staff
Design
Phase 3 clinical trial with control group, double-blind, randomized with Randomizer software with a sample size of 80 people
Settings and conduct
This study is a double-blind randomized clinical trial that will be performed at Qazvin University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry conditions: People between 18 to 50 years old Complete consent of individuals to participate in the study Having a BMI of 25 to 30 kg/m² No entry conditions: People having any allergies to the drug People with diabetes People with a history of high fat under treatment People taking vitamins and supplements People taking herbal medicines Patients with a history of inflammatory disease being treated People with known liver and kidney disease People with known lipid disease People treated with corticosteroids, aspirin and anti-lipids and hormonal drugs, hyperthyroidism and hypothyroidism People on drug treatment related to metabolic syndrome
Intervention groups
Group 1: People taking resveratrol Group 2: Control group with placebo
Main outcome variables
Measurement of body fat, Follicle-stimulating hormone, Dehydroepiandrosterone, Luteinizing hormone, fasting Insulin, Anti Mullerian hormone, Insulin-like growth factor 1, Interleukin 6, Self-monitoring of blood glucose, Testosterone, White Blood Cell, Lymphocyte, Neutrophil, Platelet, Body mass index, High-Sensitivity C-Reactive Protein, low-density lipoprotein, high density lipoprotein, triglycerides, Total antioxidant, Fasting Blood Sugar, Homeostatic Model Assessment for Insulin Resistance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200408046987N4
Registration date: 2022-01-27, 1400/11/07
Registration timing: prospective

Last update: 2022-01-27, 1400/11/07
Update count: 0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
Nematollah Gheibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8212
Email address
ngheibi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Resveratrol on some biochemical and hormonal factors in university staff
Public title
The effect of Resveratrol on some biochemical and hormonal factors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
People between 18 to 50 years old Complete consent of individuals to participate in the study Having a BMI of 25 to 30 kg/m²
Exclusion criteria:
People having any allergies to the drug People with diabetes People with a history of high fat under treatment People taking vitamins and supplements People taking herbal medicines Patients with a history of inflammatory disease being treated People with known liver and kidney disease People with known lipid disease People treated with corticosteroids, aspirin and anti-lipids and hormonal drugs, hyperthyroidism and hypothyroidism People on drug treatment related to metabolic syndrome
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used and a list of random numbers is created with Randomizer software. The software randomly divides this list from 1 to 80 between the control and intervention groups. Depending on the order of patients' referrals, they are given a number from 1 to 80 from the list of random numbers, and based on the list created by the software, which assigns each number to one of the two control and intervention groups, people enter the intervention or control group. be.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be given medication or placebo after signing the consent form. The therapist and outcome assessor will not know the type of treatment, and the data analyzer will only know the group numbers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin university of medical sciences
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.QUMS.REC.1399.569

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Measurement of fasting Insulin
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by Snible kit

2

Description
Measuring the mass of fat accumulated in the body
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, the amount of accumulated fat will be measured with a digital scale

3

Description
Measurement of Follicle Stimulating Hormone
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by Snible kit

4

Description
Measurement of Luteinizing hormone
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by Snible kit

5

Description
Measurement of Dehydroepiandroterone
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by Snible kit

6

Description
Measurement of Anti Mullerian hormone
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

7

Description
Measurement of Insulin-like growth factor 1
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

8

Description
Measurement of Interleukin 6
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

9

Description
Measurement of Self-monitoring of blood glucose
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

10

Description
Measurement of Testosterone
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

11

Description
Measurement of White Blood Cell
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by cell counter

12

Description
Measurement of Lymphocyte
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by cell counter

13

Description
Measurement of Neutrophil
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by cell counter

14

Description
Measurement of Platelet
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by cell counter

15

Description
Measurement of Body Mass Index
Timepoint
Before starting intervention and one month after intervention
Method of measurement
Weight (in kilograms) Divided by Height (in meters to the power of 2)

16

Description
Measurement of High-Sensitivity C-Reactive Protein
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by Rosh kit (in mg/dL)

17

Description
Measurement of Low-density lipoprotein
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

18

Description
Measurement of High-density lipoprotein
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

19

Description
Measurement of Triglyceride
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

20

Description
Measurement of Total Antioxidant
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

21

Description
Measurement of Fasting Blood Sugar
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

22

Description
Measurement of Homeostatic Model Assessment for Insulin Resistance
Timepoint
Before starting intervention and one month after intervention
Method of measurement
At the beginning and end of the study, it will be measured by kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: People in this group take Resveratrol (An active compound of acetylene phytoalexin) capsule supplements once a day before meals for a month.
Category
Treatment - Drugs

2

Description
Control group: People in this group take one 1000 mg capsule containing wheat flour instead of Resveratrol every day for a month before a meal.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin university of medical sciences
Full name of responsible person
Dr. Nematollah Gheibi
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 8212
Email
ngheibi@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Nematollah Gheibi
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 8212
Fax
Email
ngheibi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Nematollah Gheibi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 8212
Email
ngheibi@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Nematollah Gheibi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Bahinar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 8212
Email
ngheibi@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Nematollah Gheibi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 8212
Email
ngheibi@qums.ac.ir

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
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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