The Effect of Turmeric and Chicory seeds separately and together on Metabolic Condition and Oxidative ,Inflammatory Indices and Fetuin-A on Non-alcoholic fatty liver disease patients(NAFLD)
Object of study: Determination the effect of Turmeric and Chicory seeds separately and together on Metabolic Condition and Oxidative, Inflammatory Indices and Fetuin-A on Non-alcoholic fatty liver disease (NAFLD) patients. Study design: Random, double blind, Control with Placebo. Study population: Patients with NAFLD will be randomly divided into 4 intervention :1 : Turmeric (receive 6 tablets containing 500 mg); 2: Chicory seeds (receive 9 g powder); 3: Turmeric and Chicory seeds and 4: Placebo (receive 6 tablets) for 3 month. Inclusion criteria: Physician definitive diagnosis of NAFLD; female: 20-50 years old and male: 20-60 years old; 24.9≤BMI>40. Exclusion criteria: Alcohol intake; Gestation or Lactation or Menopause; Liver transplantation and other liver diseases and chronic or acute liver disease (Hepatitis A,B, ...); Biliary Stone; Kidney Stone; Cancers; Inheritance diseases; Using drugs like hepatotoxic drugs; Anticoagulant drugs; Vitamin. Sample size: 84 patients (21 patients in 4 groups). Study interventions: 1-Turmeric; 2- Chicory seeds; 3-Turmeric and Chicory seeds and 4-placebo. Intervention duration: 90 days. Primary outcome: The effect of supplements on FBS, Lipid profile, Liver enzymes, Metabolic Condition and Oxidative ,Inflammatory Indices and Fetuin-A. Secondary outcome: The effect of supplements on anthropometry status, Energy and Nutrient intake.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406183664N12
Registration date:2015-01-18, 1393/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
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 of Tabriz university of medical scince
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Turmeric and Chicory seeds separately and together on Metabolic Condition and Oxidative ,Inflammatory Indices and Fetuin-A on Non-alcoholic fatty liver disease patients(NAFLD)
Public title
The Effect of Turmeric and Chicory seeds on Non-alcoholic fatty liver disease patients(NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Liver steatosis on Sonographic image; ّFemale: 20-50 years old and Male: 20-60 years old; 24.9≤BMI>40. Exclusion criteria: Alcohol intake; Gestation or Lactation or Menopause; Lose Weight Diet; Anemia; Very active or Athleta; Cardiovascular disease; Pulmonary disease; Gastrointestinal disease; Renal disease; Liver transplantation and other liver diseases and chronic or acute liver disease (Hepatitis A,B, ...); Bilious impairments; Biliary Stone; Kidney Stone; Autoimmune disease; Cancers; Inheritance diseases; Using drugs like hepatotoxic drugs; Anticoagulant drugs; Vitamin A E C and omega 3 suplement; and Oral Contraceptive drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
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 Scince
Street address
Golgasht Street, Nutrition Faculty,Tabriz University of Medical Sciences, East Azarbayjan
City
Tabriz
Postal code
Approval date
2014-12-02, 1393/09/11
Ethics committee reference number
93130
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K 76
ICD-10 code description
Fatty liver
Primary outcomes
1
Description
Liver Enzyme (ALT,AST,ALP،GGT)
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry
2
Description
Metabolic condition
Timepoint
Beginning and end of the intervention
Method of measurement
FBS, TC, TG and HDL Spectrophotometry, Insulin ELISA
3
Description
Oxidative Indicies
Timepoint
Beginning and end of the intervention
Method of measurement
TAC Spectrophotometry, MDA Thiobarbituric acid
4
Description
Inflammatory Indicies
Timepoint
Beginning and end of the intervention
Method of measurement
hs-CRP Immuno Turbidimetry,TNFα and IL-6 ELISA
5
Description
Fetuin A
Timepoint
Beginning and end of the intervention
Method of measurement
Fetuin A by ELISA
6
Description
Added at 2016-01-24: ICAM1
Timepoint
Added at 2016-01-24: end of the study
Method of measurement
Added at 2016-01-24: ELISA
Secondary outcomes
1
Description
Anthropometry
Timepoint
Begining and end of intervention
Method of measurement
Scale and Meter
2
Description
Energy and Nutrient intake
Timepoint
Beginning, sixth week and end of the intervention
Method of measurement
Dietary record
Intervention groups
1
Description
Intervention Group: 500 mg Turmeric, 6 tablets/day for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention Group: 9 g/ day Chicory seeds for 12 weeks
Category
Treatment - Drugs
3
Description
Intervention Group: 500 mg Turmeric(6 tablets/day) and ( 9 g/day) Chicory seeds for 12 weeks
Category
Treatment - Drugs
4
Description
Placebo groups: Placebo,6 tablets/day for12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais and Azadi Clinic
Full name of responsible person
Aida Ghaffari
Street address
Azadi Street,Sheykholrais and Azadi Clinic,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Raf raf
Street address
Golgasht Street, Attar Neyshabori Street,Tabriz University of Medical Sciences
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 of Tabriz University of Medical Sciences
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
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Aida Ghaffari
Position
Ph.D Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht Street, Attar Neyshabori Street, Nutrition Faculty,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
ai_gh_nutry83@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Raf raf
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht Street, Attar Neyshabori Street, Nutrition Faculty,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
rafrafm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Aida Ghaffari
Position
Ph.D Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht Street, Attar Neyshabori Street, Nutrition Faculty,Tabriz University of Medical Sciences
City
Tehran
Postal code
Phone
+98 41 3335 7581
Fax
Email
ai_gh_nutry83@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)