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Efficacy of Cumin on Lipid profile and and body composition in overweight and obese women

Protocol summary

Summary
The aim of this study was the efficacy of Cumin to control Lipid profile and improve body composition in obese and overweight women . All women who are invited to referred for Nutrition Research Center, 100 subjects with age range of 20-60 years with a body mass index between 25 and 40 with the consent are enrolled. Calorie-reduced diet is prescribed for all subjects and were randomly divided into 50 groups, a control group and a group receiving cumin powder (3 grams per day). Blood samples for measurement of fasting blood sugar, Triglycerides, Cholesterol, LDL-c, HDL-c, LDL / HDL before and after the study is done. Anthropometric measurements including: weight, fat weight, lean body weight, fat mass and percentage fat, Body Mass Index and waist circumference, which were done before and after the study. Duration of the study is 3 months. According to previous studies, we expect reducing harmful blood lipids and improving body composition.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021112429N1
Registration date: 2013-05-21, 1392/02/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-21, 1392/02/31
Registrant information
Name
Roghaye Zare
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 352 9758
Email address
r_zare1391@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences , Research and technology management
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Cumin on Lipid profile and and body composition in overweight and obese women
Public title
Effect of cumin on blood fat and body composition in obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with BMI 25-40; consent to participate in the study ;No previous treatment regimen for three months before entering the study; no change in weight over 2 kg in a month prior to entering the study; lack of sensitivity to the Cumin, non-infectious diseases, diabetes, hypertension, thyroid disease and other chronic diseases based on self-declaration ; age 20-60 years Exclusion criteria: failure to cooperate in the study; the history of the program regimen; change in weight over 2 kg in the last month; allergic reactions of cumin; Disease during the study, or a history of chronic disease
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Bahonar Square, Yazd
City
Yazd
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
17/1/152167/پ

Health conditions studied

1

Description of health condition studied
hyperlipidaemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism

2

Description of health condition studied
OBESITY
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
fbs
Timepoint
3 month
Method of measurement
blood sample

2

Description
bmi
Timepoint
3 month
Method of measurement
w/h2

3

Description
tg
Timepoint
3 month
Method of measurement
blood sample

4

Description
col
Timepoint
3month
Method of measurement
blood sample

5

Description
LDL-C
Timepoint
3 month
Method of measurement
blood sample

6

Description
HDL-C
Timepoint
3 month
Method of measurement
blood sample

7

Description
LDL/HDL
Timepoint
3 month
Method of measurement
blood sample

8

Description
COL/HDL
Timepoint
3 month
Method of measurement
blood sample

9

Description
VLDL
Timepoint
3 month
Method of measurement
blood sample

10

Description
weight
Timepoint
every month until 3 month
Method of measurement

11

Description
waist size
Timepoint
3 month
Method of measurement
cm

12

Description
fat mass
Timepoint
3 month
Method of measurement
body composition analizer

13

Description
free body mascle
Timepoint
3 month
Method of measurement
body composition analizer

14

Description
percent of fat mass
Timepoint
3 month
Method of measurement
body composition analizer

15

Description
percent of free mascle mass
Timepoint
3 month
Method of measurement
body composition analizer

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group, will be asked to eat 3 grams cumin powder with yogurt for lunch and dinner, two times (each time 1/5 grams cumin + 150 ml low-fat yogurt.) Reduced calorie diet (300 kcal less than the amount necessary) to be given by a Nutrition Specialist
Category
Treatment - Drugs

2

Description
in control group: reduced calorie diet (300 kcal less than the amount necessary) to be given by a nutrition Specialist.they asked to eat 150 ml low-fat yogurt ,twice a they with out cumin.Period of study was 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition and Food Security Research Centre
Full name of responsible person
Dr Roghayeh Zare
Street address
Nutrition and Food Security Research Centre , University of Health , Imam Reza Educational and Research Center , YAZD
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Research and Technology, Yazd University of Medical Sciences
Full name of responsible person
Department of Research and Technology
Street address
Yazd University of Medical Sciences, Bahonar Square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research and Technology, Yazd 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 and Food Security Research Centre
Full name of responsible person
Roghayeh Zare
Position
MD/Research Expert
Other areas of specialty/work
Street address
Nutrition and Food Security Research Centre , University of Health , Yazd
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
R_ZARE1391@SSU.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and Food Security Research Center, University of Health
Full name of responsible person
Roghayeh Zare
Position
MD/reacerch master
Other areas of specialty/work
Street address
Department of Nutrition , University of Health , Imam Reza Research Center, Yazd
City
yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
R_ZARE1391@SSU,AC.IRz_roghayeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Roghayeh Zare
Position
MD/Research master
Other areas of specialty/work
Street address
Department of Nutrition, University of Health , Imam Reza Research Center, Yazd
City
yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
R_ZARE1391@SSU.AC.IR- z_roghayeh@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
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