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The effect of propolis and placebo supplements associated with weight loss diet on prooxidant-antioxidant balance, oxidative stress status, nutritional status, liver function and body composition in patients with non-alcoholic fatty liver

Protocol summary

Study aim
The effect of propolis and placebo supplements associated with weight loss diet on prooxidant-antioxidant balance, oxidative stress status, nutritional status, liver function and body composition in patients with NAFLD
Design
Randomized double blind clinical trial with two arm parallel groups , phase 3 on 46 patients
Settings and conduct
Individuals randomly assigned to propolis and placebo groups. The duration of the study will be 8 weeks. Also, at the beginning of the study, both groups will be given individual weight loss diets.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with non-alcoholic fatty liver (grade 1 and 2) of both sexes, age 20-50 years, BMI between 30-40 kg / m2, willingness to participate in the study and exclusion criteria including smoking and alcohol consumption, change in physical activity, pregnancy, lactation and menopause in women, skin or gastrointestinal allergies to propolis or bee products, having a weight loss diet 3 months before the study or recent surgery, taking any supplements or drugs that affect the condition and function of the liver and taking antioxidant supplements for 3 months before or during the study and also disease with similar pathogenesis
Intervention groups
The intervention group will receive a weight loss diet and propolis supplement (three capsules containing 500 mg of propolis per day) and the placebo group will receive a weight loss diet and placebo (three capsules containing 500 mg of corn starch per day) after each meal for 8 weeks.
Main outcome variables
Nutritional status (energy intake, macronutrients and antioxidant micronutrients), Pro-Oxidant-Antioxidant Balance, Oxidative status (total antioxidant capacity, glutathione peroxidase and superoxide dismutase and Malondialdehyde), Fat mass, Fat free mass, Body water, Fatty liver grade, Serum level of liver enzymes and liver fibrosis score

General information

Reason for update
Acronym
NAFLD
IRCT registration information
IRCT registration number: IRCT20100209003320N20
Registration date: 2021-06-27, 1400/04/06
Registration timing: prospective

Last update: 2021-06-27, 1400/04/06
Update count: 0
Registration date
2021-06-27, 1400/04/06
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-12-16, 1400/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propolis and placebo supplements associated with weight loss diet on prooxidant-antioxidant balance, oxidative stress status, nutritional status, liver function and body composition in patients with non-alcoholic fatty liver
Public title
The effect of propolis supplementation in treatment of non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
NAFLD (Grade 1 and 2) Age 20-50 years Body mass index(BMI) in the range of 30-40 Kg / m2 Willingness to participate in the study
Exclusion criteria:
Pregnancy, lactation and menopause in women Smoking and alcohol use Skin or gastrointestinal allergies to propolis, honey and any of the beehive products Adherence to a special diet three months before the study Consumption of chemical or herbal medicines for weight loss Taking antibiotics or various supplements that affect the levels of liver enzymes Performing weight loss surgery in the last year or strict weight loss diets in the last three months Suffering from any conditions affecting liver function Use of hepatotoxic medications Taking multivitamins or antioxidant supplements during the last 3 months
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
46 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators ((including the student and her supervisors and adviser professors as well as the patients) will be blinded to the type of the supplement (propolis or placebo) received by each patient
Placebo
Used
Assignment
Parallel
Other design features
Individuals in both the placebo and supplement groups will receive a weight loss diet; The amount of calories per person is calculated based on the Mifflin formula and 500 kcal will be deducted from the total calories in order to lose weight. The distribution of macronutrient calories will be 50% carbohydrates, 20% protein and 30% fat

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Attar Nishapuri Street , Faculty of Nutrition and Food Science
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.TBZMED.REC.1399.942

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty live
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Pro-Oxidant Antioxidant Balance (PAB)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic_ colorimetric method and read it through ELISA

2

Description
Glutathione peroxidase(GPX)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Spectrophotometric method

3

Description
Superoxide dismutase (SOD)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Spectrophotometric method

4

Description
Malondialdehyde (MDA)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Spectrophotometric method

5

Description
Total Antioxidant Capacity (TAC)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Spectrophotometric method

6

Description
Fat mass
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using bioelectric impedance analyzer

7

Description
Free fat mass
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using bioelectric impedance analyzer

8

Description
Body water
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using bioelectric impedance analyzer

9

Description
Intake of energy, macronutrients and antioxidant micronutrients
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
The intake by 3-days food record form and analysis using nutritionist 4 software

10

Description
Alanine aminotransferase
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

11

Description
Aspartate aminotransferase
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

12

Description
Gamma Glutamyl transferase
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

13

Description
Fatty liver grade
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Ultrasound findings

14

Description
Liver fibrosis score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Liver fibrosis score formula

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will receive a weight loss diet with propolis supplement (3 capsules of 500 mg per day) after each meal for 8 weeks. This supplement is provided by Shahdineh Company of Isfahan.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will receive a weight loss diet with placebo supplement (3 500 mg capsules per day of cornstarch) for 8 weeks after each meal. This supplement is provided by Shahdineh Company of Isfahan.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh Al-Rais Clinic
Full name of responsible person
Dr. ‪Mehrangiz Ebrahimi-Mameghani‬
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ebrahimimamagani@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Attar Neishaburi Street, Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street ,Attar neyshaburi street, nutriton faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Email
mebrahimimameghani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Email
mebrahimimameghani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamideh Nazari-bonab
Position
MSC student of nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St, Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
hamideh.nazarii@gmail.com

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
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
Data collected for the primary outcomes will be shared
When the data will become available and for how long
Access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers , for conducting meta-analysis
From where data/document is obtainable
Ms.Hamideh, Nazari bonab, E-mail address:hamideh.nazarii@gmail.com, cellphone number: 00989148616822
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of his Meta-analysis . His request will be assessed and , if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days
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