Protocol summary

Summary
The aim of this study is to evaluate the effects of cumin extract on body mass index, appetite, insulin resistance index and serum levels of tumor necrosis factor α, zinc alpha 2 glycoprotein and lipid profile in children and adolescents with obesity. Inclusion criteria are as follows: children and adolescents aged 7-12 years old with BMI above 95th percentile for their age and gender, absence of liver, kidney, digestive, endocrine and cardiovascular diseases and acute or chronic infections, not using drugs especially those that affect obesity like metformin and herbal supplements. Exclusion criteria are as follows: unwillingness to participate or continue the intervention, necessity to use medications that influence obesity or lipid and carbohydrate metabolism, affected by diabetes, thyroid disorders or other endocrine, digestive or kidney disorders, appearance of incompatibility or allergy to cumin extract. Study population: 80 children and adolescents aged 7-12 years old which are randomly assigned to two groups receiving either cumin extract or placebo each group containing 40 subjects. Intervention consists of cumin extract prescribed as pearl capsules produced by Barij Essence Co. (Iran), two capsules each day (1 capsule before lunch and 1 capsule efore dinner) for two months. Placebo is prescribes simultaneously.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092624198N1
Registration date: 2017-06-07, 1396/03/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Mitra Nourbakhsh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3109
Email address
nourbakhsh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cumin`s seed essential oil on body mass index, appetite situation, insulin resistance,leptin, as well as serum concentration of TNF alpha and Zinc alpha 2 glycoprotein in 7-12 year-old obese and overweight children
Public title
Evaluation Of the effect of cumin`s seed essential oil on Obese children by assessing biochemical biomarkers as well as evaluation of body mass index.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria 1- healthy children without any history of liver disease, 2- No sign and symptoms of hypothyroidism, Cushing syndrome , diabetes 3- No sign of hypertension Exclusion criteria 1-children who show higher level of hepatic enzymes in the first laboratory evaluation.(before starting intervention) 2-children who consume glucose regulator medicine such as Glucophage or metformin. 3-children who intake any medicine which may have any interference on appetite or obesity trend such as Hydrocortisone.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahid Sadoughi University Of Medical Sciences
Street address
Bahonar Square Yazd. IRAN
City
Yazd
Postal code
Approval date
2015-10-21, 1394/07/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.197

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
BMI
Timepoint
before intervention, two months after intervention
Method of measurement
weight in kg / height in meters squared

2

Description
fasting blood sugar
Timepoint
before intervention, two months after intervention
Method of measurement
glucose oxidase colorimetry

3

Description
SGOT
Timepoint
before intervention,one month after intervention, two months after intervention
Method of measurement
colorimetry

4

Description
SGPT
Timepoint
before intervention,one month after intervention, two months after intervention
Method of measurement
colorimetry

5

Description
Insulin
Timepoint
before intervention, two months after intervention
Method of measurement
ELISA

6

Description
TNF alpha
Timepoint
before intervention, two months after intervention
Method of measurement
ELISA

7

Description
Zinc Alpha 2 Glycoprotein
Timepoint
before intervention, two months after intervention
Method of measurement
ELISA

8

Description
HOMA-IR
Timepoint
before intervention, two months after intervention
Method of measurement
calculation

9

Description
leptin
Timepoint
before intervention, two months after intervention
Method of measurement
ELISA

10

Description
Total Cholestrol
Timepoint
before intervention, two months after intervention
Method of measurement
colorimetry

11

Description
TG
Timepoint
before intervention, two months after intervention
Method of measurement
calorimetri

12

Description
LDL
Timepoint
before intervention, two months after intervention
Method of measurement
colorimetry

13

Description
HDL
Timepoint
before intervention, two months after intervention
Method of measurement
colorimetry

14

Description
Appetite
Timepoint
before intervention,one month after intervention, two months after intervention
Method of measurement
CEBQ questionnaire

Secondary outcomes

1

Description
Creatinin
Timepoint
before intervention and 2 months after intervention
Method of measurement
colorimetry

2

Description
complete blood count
Timepoint
before intervention and 2 months after intervention
Method of measurement
microscopy

Intervention groups

1

Description
cumin`s seed essential oil orally administered as soft gel capsules twice daily (before lunch and before dinner) 2 months duration
Category
Treatment - Drugs

2

Description
placebo similar to the cumin seed oil capsule in shape and color orally administered twice daily before lunch and dinner two months duration
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Metabolic Disorders Research Center, Endocrinology & Metabolism Research Institute
Full name of responsible person
Dr. Maryam Razzaghy Azar
Street address
5th floor, Shahrivar St., Diabetes and Metabolism Clinic, North Kargar St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr. Neda Mehrdad
Street address
5th floor, Shariati Hospital, North Kargar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
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
Obesity Prevention and Treatment Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Zyadloo
Position
MSc
Other areas of specialty/work
Street address
24, Parvaneh St., Yaman St., Velenjak
City
Tehran
Postal code
Phone
+98 912 471 5191
Fax
Email
healthydiet_28@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 3109
Fax
Email
nourbakhsh.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
PhD
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
1449614535
Phone
+98 912 287 4740
Fax
Email
nourbakhsh.m@iums.ac.ir
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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