Comparison of the effect of rice husk and rice bran in combination with limited energy diet on anthropometry parameters, lipid profiles and inflammatory factors in overweight and obese adults
The present study aimed to comparison of the effect of rice husk and rice bran in combination with limited energy diet on anthropometry parameters, lipid profiles and inflammatory factors in healthy overweight and obese adults, general inclusion criteria are men and women 20–50 years with low physical activity and exclusion criteria are having heavy physical activity and chronic disease such as diabetes, 105 of the Shahid Rajaee Hospital staff assigned to one of three diet arms (at energy requirements 500 kcal lower than for weight maintenance): (1) low caloric diet (control); (2) low caloric diet with rice bran (70 g rice bran) or (3) low caloric diet with rice hull(25 g rice husk), this study following for 12 weeks to decrease weight and waist circumference in overweight and obese adults.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040721652N1
Registration date:2015-05-30, 1394/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Fahimeh Edrissi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
stud2301120899@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rice husk and rice bran in combination with limited energy diet on anthropometry parameters, lipid profiles and inflammatory factors in overweight and obese adults
Public title
the effect of consuming rice husk and rice bran on weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy men and women 20–50 years with BMI>25; stable weight for more than 6 months; low physical activity. Exclusion criteria: hormone therapy; taking supplements; lipid-lowering medication; weight-lowering medication; smoking; alcoholism; major illnesses (including diabetes mellitus; chronic renal failure; uncontrolled hypertension (>180/100 mm Hg)); Iron deficiency; pregnancy/ lactation; fiber allergies; using low caloric diet at 6 months; reporting a weight change of 5 kg during the previous 6 months; heavy physical activity.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Karim Khan Zand Blvd, Shiraz
City
Shiraz
Postal code
Approval date
2015-03-08, 1393/12/17
Ethics committee reference number
7419-9379-CT
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
weight
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
Seca scale
2
Description
Waist circumference
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
nonstretchable tape measure
Secondary outcomes
1
Description
total cholestrol
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
autoanalyzer bt1500
2
Description
triglycerides
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
autoanalyzer bt1500
3
Description
HDL- cholestrol
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
autoanalyzer bt1500
4
Description
LDL-cholestrol
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
autoanalyzer bt1500
5
Description
CRP
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
ELISA
6
Description
IL-6
Timepoint
at baseline and at 12 weeks following end of intervention
Method of measurement
colorimetry
Intervention groups
1
Description
rice husk( 25gr/ daily) in combination with limited energy diet for 12 weeks
Category
Treatment - Other
2
Description
rice bran( 70 gr/daily) in combination with limited energy diet for 12 weeks
Category
Treatment - Other
3
Description
limited energy diet
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Trauma Center (Shahid Rajaee Hospital)
Full name of responsible person
Fahimeh Edrissi
Street address
Shahid Rajaee Hospital, Chamran Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz University of Medical Sciences, Karim Khan Zand Blvd, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Nutrition and Food Sciences
Full name of responsible person
Fahimeh Edrissi
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
Departmant of clinical Nutrition, School of Nutrition and Food Sciences, Razi Blvd, Modares Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
+98 71 3725 7288
Email
stud2301120899@suma.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrition and Food Sciences
Full name of responsible person
Mosa Salehi
Position
Associate Professor of Nutrition
Other areas of specialty/work
Street address
Departmant of Clinical Nutrition, School of Nutrition and Food Sciences, Razi Blvd, Modares Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
salehi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nutrition and Food Sciences
Full name of responsible person
Fahimeh Edrissi
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
Departmant of Clinical Nutrition, School of Nutrition and Food Sciences, Razi blvd, Modares Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)