IRCT | The effect of pomegranate peel supplementation on the serum levels of IL-6, IL-10, disease activity index and quality of life in patients with mild to moderate ulcerative colitis: a double-blind clinical trial.

Protocol summary

Study aim: The purpose of this project is to investigate the effect of pomegranate peel supplementation on serum levels of Interleukins 6, 10, disease activity index, and quality of life, and determine and compare the average changes of qualitative and quantitative confounding variables between two groups at the end of the study and within each group at the beginning and end of the study.
Design: A clinical trial with a control group, with parallel groups, double-blind, randomized, on 80 patients. To avoid selection bias, we use the random allocation method, blocks with the Randomization.com website.
Settings and conduct: Patients are diagnosed and informed in Hazrat Rasool Akram and Imam Khomeini Hospitals. Qualified people are divided into the intervention or control group. At the beginning and at the end of the study, after 10-12 hours of fasting, 10 cc of blood will be taken for checking IL-6 and IL-10, and IBDQ-9, IPAQ, P-SCCAI, and three dietary records will be completed. The statistical consultant will prepare the codes from 1 to 80 which will be posted on the supplement packages and envelopes and will be provided to the patients, and no other person will know the type of treatment.
Participants/Inclusion and exclusion criteria: Patients with ulcerative colitis in the mild to moderate stage referring to the specialized clinic of digestive diseases and patients who consent to the disease with an age equal to 18 years, BMI above 18.5, and less than 30 weight (kg2), who are taking special medications with no other specific disease, and do not change their medication dose, activity, and food plan.
Intervention groups: The intervention group and the control group will receive a supplement of 500 mg of dry extract of pomegranate peel or a placebo for eight weeks, respectively.
Main outcome variables: Interleukin 6 serum level; interleukin 10 serum level; disease activity index; Quality of Life

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20091114002709N60

Registration date: 2023-07-01, 1402/04/10

Registration timing: registered_while_recruiting

Last update: 2023-07-01, 1402/04/10

Update count: 0
Registration date: 2023-07-01, 1402/04/10

Registrant information: Name

Farzad Shidfar

Name of organization / entity

Iran University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 21 8862 2755

Email address

shidfar.f@iums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-06-25, 1402/04/04
Expected recruitment end date: 2024-05-21, 1403/03/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of pomegranate peel supplementation on the serum levels of IL-6, IL-10, disease activity index and quality of life in patients with mild to moderate ulcerative colitis: a double-blind clinical trial.

Public title: Investigating the effect of pomegranate peel supplement in ulcerative colitis
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

1. Patient consent to participate in the study 2. Aged 18 years or older (age ≤ 18 years) 3. BMI above 18.5 and less than 30 kg/m2 (30 ≤ BMI ≤ 18.5) 4. Diagnosis of ulcerative colitis by a specialist 5. People with mild to moderate ulcerative colitis according to specialist diagnosis and the Partial Mayo scoring index 6. Users of oral drugs of the 5-aminosalicylic acid group (pentasa, mesalazine or asacol, sulfasalazine) as well as immunomodulatory drugs (azathioprine, methotrexate, prograf, selpest or 6-mercaptopurine).

Exclusion criteria:

1. Changing the type and dosage of the drug used during the last month 2. Pregnant or lactating women 3. Suffering from other diseases, including digestive diseases, autoimmune diseases, cancer, inflammatory and infectious diseases 4. Use of multivitamin-mineral, omega-3, polyphenolic, antioxidants, and herbal supplements during the past month (except for commonly prescribed supplements in ulcerative colitis) 5. Use of corticosteroids, NSAIDs (profen, aspirin and diclofenac), and anti-TNF drugs (Cinnora or Adalimumab, Infliximab or Remicade)
Age: From 18 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Care provider
Investigator

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

Randomization description

This study uses the random allocation method, blocks, to avoid selection bias. For this purpose, the Randomization.com website is used to create blocks. Then, according to the generated sequence, 40 patients were placed in the intervention group and 40 patients in the comparison group

Blinding (investigator's opinion)

Double blinded

Blinding description

Codes 1 to 80 will be prepared by the statistical consultant and stuck on the supplementary packages and their envelopes. Medicine will be placed in closed paper envelopes along with 3 questionnaires as a 24-hour reminder. The doctor, researcher, individual people, and the person who provides the envelopes to the patients are unaware of the type of treatment and only the consultants of the statistical plan know about the codes. At the beginning of the case study, after blood sampling, envelopes are received in the order of numbers and the responsible person writes down the received code and the patient's name. The order of diagnosis of patients for blinding will be provided to statistical consultants until the end of the study, and other people will be unaware of the plan.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committees of Iran university of medical scinces

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Shahid Hemmat Highway, 1449614535, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535
Approval date: 2023-06-25, 1402/04/04
Ethics committee reference number: IR.IUMS.REC.1402.255

Health conditions studied

1

Description of health condition studied: Inflammatory bowel disease, ulcerative colitis
ICD-10 code: K51
ICD-10 code description: Ulcerative colitis

Primary outcomes

1

Description: Interleukin 6
Timepoint: ََAt the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week)
Method of measurement: Blood test

2

Description: Interleukin 10
Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week)
Method of measurement: Blood test

3

Description: Disease activity index
Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week)
Method of measurement: Disease activity index questionnaire

4

Description: Quality of life
Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week)
Method of measurement: IBD quality of life questionnaire

Secondary outcomes

1

Description: Blood pressure
Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week)
Method of measurement: Upper arm blood pressure digital monitor

Intervention groups

1

Description: Intervention group: The group receiving the supplement of 500 mg of dry pomegranate peel extract for eight weeks. In this study, the supplements of Adib Elixir herbal products company with health approval (8975464292723001 IRC: ) are used. Pomegranate peel dry extract is produced by this company in capsule cover and 500 mg content.
Category: Treatment - Drugs

2

Description: Control group: The group receiving 500 mg placebo supplement for eight weeks. Placebo capsules are also prepared from Adib Elixir company. These capsules contain 500 mg of medicated corn starch.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Honor Rasool Akram therapeutic educational center

Full name of responsible person

Dr Shahram Agah

Street address

Sttar khan - Niyayesh street

City

Tehran

Province

Tehran

Postal code

۱۴۴۵۶۱۳۱۳۱

Phone

+98 991 209 2805

Email

shahramagah2013@yahoo.com

2

Recruitment center: Name of recruitment center

Imam Khomeini Hospital

Full name of responsible person

Foroogh Alborzi

Street address

Imam khomeini hospital- Doctor gharib street- at the end of keshavarz boulevard

City

Tehran

Province

Tehran

Postal code

۱۴۱۹۷۳۳۱۴۱

Phone

+98 991 209 2805

Email

foroogh1983@yahoo.com

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Mohsen Asadi Lari

Street address

School of Medicine, Crossroads of Shahid Hemmat and Shahid Chamran Expressways

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵

Phone

+98 21 86701

Email

info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Iran 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

Iran University of Medical Sciences

Full name of responsible person

Farzad Shidfar

Position

faculty member

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

School of Health, Iran University of Medical Sciences, Shahid Hemmat highway

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵

Phone

+98 21 8862 2755

Fax

+98 21 8862 2533

Email

shidfar.f@iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Farzad Shidfar

Position

faculty member

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

School of Health, Iran University of Medical Sciences, Shahid Hemmat highway

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵

Phone

+98 21 8862 2755

Fax

+98 21 8862 2533

Email

shidfar.f@iums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Farzad Shidfar

Position

Faculty member

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

School of Health, Iran University of Medical Sciences, Shahid Hemmat highway

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵

Phone

+98 21 8862 2755

Fax

+98 21 8862 2533

Email

shidfar.f@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: According to the additional protocol, the personal information of the candidates is considered confidential.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: Yes - There is 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: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Anthropometric data, blood variables, and scores of questionnaires used
When the data will become available and for how long: From September, 2024
To whom data/document is available: The presenter and main collaborator
Under which criteria data/document could be used: If the university officially requests
From where data/document is obtainable: The presenter and main collaborator
What processes are involved for a request to access data/document: Official application through the university to the administrator
Comments

The effect of pomegranate peel supplementation on the serum levels of IL-6, IL-10, disease activity index and quality of life in patients with mild to moderate ulcerative colitis: a double-blind clinical trial.