1. Home
  2. Approved trials
  3. » فارسی

Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Hs-CRP, MDA, TAC, Blood Pressure, Anthropometric measurement, Quality of life, Sleep and Appetite in Patients with Non-Alcoholic Fatty Liver Disease

Protocol summary

Study aim
Evaluation of the effect of rosemary leaves consumption with weight loss diet on Hs-CRP, malondialdehyde, total antioxidant capacity, blood pressure, anthropometric indices, quality of life, sleep and appetite in patients with non-alcoholic fatty liver
Design
Study Type: Double-blind Randomized Clinical Trial. Sample size: 120 people (based on body mass index and 95% confidence interval, 80% test power and 10% prediction of sample loss). Groups: 1) Intervention (n = 60): receive 4 grams of rosemary powder daily with weight loss diet. 2) Control (60 people): Get 4 grams of starch daily with weight loss diet. Duration of intervention: 8 weeks. Sampling Method: Available Randomization: Using random blocks (30 blocks of 4 according to the sample size of 120). Hide: Use unique code on sachets Study phase: 2
Settings and conduct
The present study was a randomized, double-blind clinical trial of 8 weeks in patients with non-alcoholic fatty liver referring to the Gastroenterology and Liver Clinic of Razi Hospital in Rasht, which is based on the approval of a specialist and preliminary studies with inclusion criteria. will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction, 1 to 3 degrees of nonalcoholic fatty liver, increased liver enzymes than normal, body mass index above normal, adult Exclusion criteria: Conditions leading to hepatic steatosis, use of any dietary supplement and weight-loss medication, severe weight loss diet, smoking, pregnancy, or lactation
Intervention groups
1: Intervention (n = 60): daily consumption of 4 grams of rosemary leaf powder with weight loss diet and physical activity recommendation 2: Control (n = 60): receive 4 grams of starch with weight loss diet and exercise recommendation
Main outcome variables
High sensitivity C-reactive protein, malondialdehyde, total antioxidant capacity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120415009472N19
Registration date: 2019-10-14, 1398/07/22
Registration timing: registered_while_recruiting

Last update: 2019-10-14, 1398/07/22
Update count: 0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Hs-CRP, MDA, TAC, Blood Pressure, Anthropometric measurement, Quality of life, Sleep and Appetite in Patients with Non-Alcoholic Fatty Liver Disease
Public title
Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Hs-CRP, MDA, TAC, Blood Pressure, Anthropometric measurement, Quality of life, Sleep and Appetite in Patients with Non-Alcoholic Fatty Liver Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to participate in studying and signing consent Evidence of hepatic steatosis in liver ultrasonography (grade 1 to 3 fatty liver) Increased liver enzymes than normal (AST> 38 and ALT> 40 for men and AST> 31 and ALT> 33 for women) BMI in the range of 25-40 kg / m2 aged between 20 and 65 years
Exclusion criteria:
Unwillingness to participate in the study Secondary conditions that lead to hepatic steatosis, including: alcohol consumption, hereditary disorders affecting liver status (hemochromatosis and Wilson's disease), and known autoimmune disease Other chronic and acute liver diseases and disorders such as hepatitis, cirrhosis, celiac disease, diabetes, thyroid disorders, cardiovascular, renal, pulmonary and inflammatory diseases (rheumatism) History of taking hepatotoxic drugs (methotrexate, amiodarone, tamoxifen, nifedipine, corticosteroids, valproate and antiviral drugs) as well as anticoagulants such as aspirin Use of any nutritional supplement in the past two months Use of weight-loss drugs over the past two months Having a severe weight loss diet (more than 10% weight loss) over the past three months smoking Pregnancy or lactation
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, patients referred to the Gastroenterology and Liver Clinic of Razi Hospital in Rasht will be selected by available sampling method. For randomization, the permuted block randomization will be used with 4 blocks. According to the sample size of 120, 30 blocks of 4 will be produced using the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment in the randomization process, unique code will be used on the sachets that the code will generate by the software. As each individual enters the study, based on the sequence generated, the powder containing the code in which the code is intended will be assigned to the individual, and the rosemary or placebo powder will be coded by a third party who is unaware of the contents of the sachets. It is randomly divided into two groups by the above method. None of the patients, as well as the researcher, will be aware of the group in which the patients will be placed and the type of intervention (rosemary or placebo).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Sheikh Fazlollah and Chamran Intersection, Hemmat Highway, Iran University of Medical Sciences,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.IUMS.REC.1398.495

Health conditions studied

1

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

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Colorimetric method

2

Description
Total Antioxidant Capacity
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Colorimetric method

3

Description
High sensitivity C-reactive protein
Timepoint
Before intervention and 12 weak after intervention
Method of measurement
Turbidometric method

Secondary outcomes

1

Description
Systolic blood pressure
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Mercury barometric

2

Description
Diastolic blood pressure
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Mercury barometric

3

Description
Weight
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Scales

4

Description
Waist
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Meter

5

Description
Hip circumference
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Meter

6

Description
Waist to hip ratio
Timepoint
Before intervention and 8 months after intervention
Method of measurement
calculation

7

Description
Body fat percentage
Timepoint
Before intervention and 8 months after intervention
Method of measurement
inbody

8

Description
BMI
Timepoint
Before intervention and 8 months after intervention
Method of measurement
calculation

9

Description
Quality of Life
Timepoint
Before intervention and 8 months after intervention
Method of measurement
SF-36 questionnaire

10

Description
sleep quality
Timepoint
Before intervention and 8 months after intervention
Method of measurement
The Pittsburgh Sleep Quality questionnaire

11

Description
Appetite
Timepoint
Before intervention and 8 months after intervention
Method of measurement
CNAQ questionnaire

Intervention groups

1

Description
Intervention group (n = 60): Low-calorie diet and physical activity design based on the Adult Overweight and Obesity Control Guide (published by the US National Heart, Lung, and Blood Institute). The low-calorie diet will be calculated as 500 kcal less than the energy needed by each patient, and the macronutrient division is calculated as 30% fat, 15% protein and 55% carbohydrate. The diet will be adjusted according to the amount of units needed for each individual diet and a list of food substitutes will be explained. Physical activity is also recommended to all patients for at least 3 days a week. Diet adherence and physical activity will be assessed weekly through telephone interviews as well as using dietary intake records and 24-hour physical activity at the beginning and end of the study (35). The intervention group also received 4 grams of rosemary leaf powder daily.
Category
Treatment - Drugs

2

Description
Control group (n = 60): Low-calorie diet and physical activity similar to the intervention group with 4 grams of starch powder (placebo) daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical and Research Center of Razi Hospital in Rasht
Full name of responsible person
Saeedeh ebrahimzadeh
Street address
Razi Street, Razi Medical Training Center, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Email
razi.hospital@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research Iran University of Medical Sciences
Full name of responsible person
Dr Ali Javad Moosavi,Assistant of Research and Technology,Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran,Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research 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
Dr Nahid Aryaeian
Position
Phd in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Iran University of Medical Sciences, the intersection of Sheikh Fazlallah and Chamran, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8877 9118
Email
n-aryaeian@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
Professor Assistant / Nutrition PhD.
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8877 9118
Email
n-aryaeian@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
saeedeh ebrahimzadeh
Position
MS Student in Health Sciences in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, School of health ,Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
saeedeh.7272.eb@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
Only a section of the data, such as primary outcomes information or the like, will be shared.
When the data will become available and for how long
Access period start 6 months after results publishing.
To whom data/document is available
The obtained data from current study will be available only for working researchers in academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis.
From where data/document is obtainable
Applicants can be communicated to correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran university of Medical Sciences, Hemat Express way, Tehran Cell phone:+98 21 8670 4743 Email:n-aryaeian@sina.tums.ac.ir
What processes are involved for a request to access data/document
publishing in scientific- research journals Applicants will be given access to the obtained data from current study by sending an email to the correspond author.
Comments
Loading...