Comparing the effect of probiotic and conventional yoghurt consumption on serum level of adiponectin in patients with non-alcoholic fatty liver disease (NAFLD)
objectives:
Effect of probiotic yogurt and conventional yogurt on serum adiponectin levels in patients with nonalcoholic fatty liver disease and compared them with each other
Design:
A double-blind randomized controlled trial
Setting and conduct:
Selected samples are divided into two groups:intervention and placebo. 8-week intervention takes place. Ultrasound, anthropometric measurements (weight, height), serum adiponectin levels and the three day 24- hour dietary recall at baseline and again at the end of the study will be assessed and compared between the two groups.
Participants including major eligibility criteria:
Women aged 20-50 years (premenopausal) and in men 20-65 years with body mass index (BMI) range between 25 to 40 kg/ m2 that suffer from Nonalcoholic fatty liver disease
Participants including major eligibility criteria:
Women aged 50-20 years (premenopausal) and men 65-20 years 40-25 years with a body mass index referred to Sheikh Alryys city of Tabriz
Interventions:
intervention group: 300 grams probiotic yoghut 1.5% fat daily and placebo group 300 grams of conventional yogurt 1.5% fat daily.
main outcome :
Serum adiponectin levels
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210313664N8
Registration date:2012-11-28, 1391/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
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
nutrition Research center, 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 serum level of adiponectin in patients with non-alcoholic fatty liver disease (NAFLD)
Public title
Comparing the effect of probiotic and conventional yoghurt consumption 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; suffering from Nonalcoholic fatty liver disease
Exclusion criteria: suffering from gastrointestinal disease; diabetes and rheumatoid arthritis; Receiving Antibiotics during the two weeks before the study 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; cachexia
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Ethics Committee of Tabriz University of Medical Science
Street address
Golgasht street, Tabriz.East Azarbayjan
City
Tabriz
Postal code
Approval date
2012-10-30, 1391/08/09
Ethics committee reference number
9135
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
k75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
adiponectin
Timepoint
Baseline and at the end of intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 300 g probiotic yogurt
Category
Other
2
Description
Placebo group: 300 g conventional yoghurt
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 science
Full name of responsible person
Vice-chancellor for research-Tabriz University of Medical Science
Position
Assistant professor in Nutrition
Other areas of specialty/work
Street address
Golgasht street, Tabriz.East Azarbayjan
City
Tabriz
Postal code
51665-118
Phone
+98 41 1335 7311
Fax
Email
ostadrahimia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Maryam Rafraf
Position
Assistant professor in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
51665-118
Phone
00
Fax
Email
rafrafm@tbzmed.ac.ir
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, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
safoora.nabavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)