1. Home
  2. Approved trials
  3. » فارسی

Comparing the effect of probiotic and conventional yoghurt consumption on metabolic status and serum hs-CRP level, leptin and paraoxonase 1 enzyme activity in patients with non-alcoholic fatty liver disease (NAFLD)

Protocol summary

Summary
This study is a randomized double-blind placebo controlled trial that subject from women aged 20-50 years (premenopausal) and men 20-65 years with BMI=25-40 kg/m2 will be recruited from Sheykhorraeis clinic of Tabriz. The aim of the study is determining the effect of probiotic and conventional yoghurt consumption on metabolic status and serum hs-CRP level, leptin and paraoxonase 1 enzyme activity in patients with non-alcoholic fatty liver disease (NAFLD). Patients will be divided randomly to 2 groups; treatment and placebo. Treatment group receive 300 g of probiotic yoghurt 1.5% fat containing at least 107 cfu/g probiotic per day and placebo group 300 g of conventional yoghurt 1.5% fat for 8 weeks. Ultrasonography, Anthropometric measurements (weight, height), biochemical criteria including plasma level of Aspartat aminotransferase, Alanin aminotransferase,Total cholesterol, trigliceride, High density lipoprotein, Low density lipoprotein, Fasting blood glucose, Insulin resistance, Malondialdehyde, leptin hormone, hs-CRP and paraoxonase 1 enzyme activity appetite evaluation, 3 days of 24 hour food recall will be measured before and after treatment and will be compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205293664N7
Registration date: 2012-06-17, 1391/03/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-06-17, 1391/03/28
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of probiotic and conventional yoghurt consumption on metabolic status and serum hs-CRP level, leptin and paraoxonase 1 enzyme activity in patients with non-alcoholic fatty liver disease (NAFLD)
Public title
Effect of probiotic yoghurt in patients with non-alcoholic fatty liver disease (NAFLD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who agree to participate in the study; women aged 20-50 years (premenopausal) and in men 20-65 years; BMI range between 25 to 40 kg/ m2 and suffering from nonalcoholic fatty liver disease. Exclusion criteria: suffering from gastrointestinal disease, diabetes and rheumatoid arthritis; receiving antibiotics during the two weeks before and during the study; follow the diet and weight loss; receiving supplements of vitamins, antioxidants, fiber and omega-3 within 3 weeks before baseline and during the study; presence of pregnancy or lactation or menopause; taking contraceptive drugs; liver transplantation; alcohol intake; any cause of chronic liver disease other than NAFLD, such as testing positive for hepatitis B, hepatitis C and autoimmune hepatitis – Immune; history of cancer and treatment; performing a complete intravenous feeding; rapid weight loss; cut part of the intestine and gastropathy; drugs such as corticosteroids, amiodarone, tamoxifen, cyclins, perhexiline, methotrexate, aspirin and hydralazine; presence of inherited Hemochromatosis (transferrin saturation greater than 45%) and Wilson's disease; Cholestatic liver disease; advanced liver disease; heart failure; thyroid (abnormal TSH) and renal disease; gastric bypass surgery and cachexia.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for research-Tabriz University of Medical Science
Street address
Golgasht street, Tabriz.East Azarbayjan
City
Tabriz
Postal code
51665-118
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
9135

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76
ICD-10 code description
Other diseases of liver

Primary outcomes

1

Description
Liver Enzymes(ALT,AST)
Timepoint
Baseline and at the end of intervention
Method of measurement
Autoanalyzer

2

Description
Total Cholesterol
Timepoint
Baseline and at the end of intervention
Method of measurement
Spectrophotometry

3

Description
Triglyceride
Timepoint
Baseline and at the end of intervention
Method of measurement
Spectrophotometry

4

Description
HDL
Timepoint
Baseline and at the end of intervention
Method of measurement
Spectrophotometry

5

Description
LDL
Timepoint
Baseline and at the end of intervention
Method of measurement
Friedewald Formula

6

Description
Insulin
Timepoint
Baseline and at the end of intervention
Method of measurement
ELIZA

7

Description
HOMA-IR
Timepoint
Baseline and at the end of intervention
Method of measurement
Formula

8

Description
Fasting Blood Sugar
Timepoint
Baseline and at the end of intervention
Method of measurement
spectrophotometry

9

Description
Malondialdehyde
Timepoint
Baseline and at the end of intervention
Method of measurement
Spectrophotometry

10

Description
hsCRP
Timepoint
Baseline and at the end of intervention
Method of measurement
immunotorbidometry

11

Description
Leptin
Timepoint
Baseline and at the end of intervention
Method of measurement
ELIZA

12

Description
activity of PON1 Enzyme
Timepoint
Baseline and at the end of intervention
Method of measurement
Spectrophotometry

13

Description
AST/ALT
Timepoint
Baseline and at the end of intervention
Method of measurement
Formula

Secondary outcomes

1

Description
Dietary Factors
Timepoint
Baseline and at the end of intervention
Method of measurement
3-day 24h dietary recalls

2

Description
Body Mass Index
Timepoint
Baseline and at the end of intervention
Method of measurement
Formula

3

Description
echogeneocity of liver tissue
Timepoint
Baseline and at the end of intervention
Method of measurement
Ultrasonography

Intervention groups

1

Description
Intervention group: 300 gr probiotic yoghurt daily
Category
Other

2

Description
Placebo group: 300 gr conventional yoghurt daily
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheykhorraeis clinic in Tabriz
Full name of responsible person
Safoora Nabavi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research-Tabriz University of Medical Science
Full name of responsible person
Alireza Ostadrahimi
Street address
Golgasht street, Tabriz.East Azarbayjan
City
Tabriz
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-Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Safoora Nabavi
Position
MSc student in community nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, AttareNeishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 918 372 9871
Fax
Email
safoora.nabavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Rafraf
Position
Assistant professor in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, AttareNeishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 914 314 5786
Fax
Email
rafrafm@tbzmed.ac.ir; safoora.nabavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Safoora Nabavi
Position
MSc student in community Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, AttareNeishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 918 372 9871
Fax
Email
safoora.nabavi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...