1. Home
  2. Approved trials
  3. » فارسی

The effect of curcumin supplementation on anthropometric indices, glycemic indices, inflammatory markers, oxidative stress markers and chemerin in healthy overweight/obese female students

Protocol summary

Study aim
To determine the effect of curcumin supplementation on anthropometric indices, glycemic indices, inflammatory markers, oxidative stress markers and chemerin in healthy overweight/obese female students
Design
In this study, 60 overweight/obese students which have documents in pediatric heart research center will be chosen based on inclusion criteria of the study. participants will be randomly assigned to intervention or placebo group.
Settings and conduct
This study will be performed in pediatric heart research center. The researchers, participants and statistical analyzer will be unaware of assigned treatments.
Participants/Inclusion and exclusion criteria
overweight or obese girls (BMI percentile >=85 for age), age 13-18 years old, having menstural cycles far at least 6 months, not consuming any drugs including drugs that could affect on lipid and carbohydrate metabolism such as statins and metformin, hormone therapy drugs, multivitamin-minerals, corticosteroids and nonsteroidal anti-inflammatory drugs no history of chronic diseases including diabetes, hypo- and hyperthyroidism, liver or renal diseases, cardiovascular diseases, polycystic ovary syndrome
Intervention groups
curcumin and placebo In curcumin group, subjects will consume 500 milligram curcumin capsules for 10 week. In placebo group, subjects will consume placebo capsules which are completely similar to the main intervention. A weigh maintenance or mild weight loss diet will be prescribe for subjects based on their body mass index percentile for two intervention and placebo group.
Main outcome variables
Anthropometric indices, glycemic indices

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20171107037302N1
Registration date: 2017-12-26, 1396/10/05
Registration timing: registered_while_recruiting

Last update: 2017-12-26, 1396/10/05
Update count: 0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 3834
Email address
s.sarafbank@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-09, 1396/07/17
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin supplementation on anthropometric indices, glycemic indices, inflammatory markers, oxidative stress markers and chemerin in healthy overweight/obese female students
Public title
curcumin supplementation in overweight/obese female students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
overweight or obese girls (BMI percentile >=85 for age), age 13-18 years old, having menstural cycles far at least 6 months
Exclusion criteria:
not consuming any drugs including drugs that could affect on lipid and carbohydrate metabolism such as statins and metformin, hormone therapy drugs, multivitamin-minerals, corticosteroids and nonsteroidal anti-inflammatory drugs no history of chronic diseases including diabetes, hypo- and hyperthyroidism, liver or renal diseases, cardiovascular diseases, polycystic ovary syndrome
Age
From 13 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
students will be matched for BMI percentile. By using Stratified Blocked Randomization method, students will be assigned to intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, students will not be aware of type of received intervention. Furthermore, before the beginning of intervention, curcumin supplements and their placebo which are completely similar to each other will be coded to A and B by a third person rather than main researcher to keep blindness of study. The statistical analyzer will also be unaware of the allocation of treatments
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUI.REC.1396.3.160

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
weight
Timepoint
At the beginning of study- week 10
Method of measurement
Seca scale

2

Description
height
Timepoint
At the beginning of study- week 10
Method of measurement
Strip meter

3

Description
waist circumference
Timepoint
At the beginning of study- week 10
Method of measurement
Strip meter

4

Description
hip circumference
Timepoint
At the beginning of study- week 10
Method of measurement
Strip meter

5

Description
Body mass index
Timepoint
At the beginning of study- week 10
Method of measurement
formula

6

Description
Fasting blood sugar
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

7

Description
fasting Insulin
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

8

Description
Homeostatic model assessment of insulin resistance
Timepoint
At the beginning of study- week 10
Method of measurement
formula

Secondary outcomes

1

Description
C-reactive protein
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

2

Description
Interleukin 6
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

3

Description
Chemerin
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

4

Description
Total Antioxidant Capacity
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

5

Description
Malondialdehyde
Timepoint
At the beginning of study- week 10
Method of measurement
biochemical assessment

Intervention groups

1

Description
Intervention group: Subjects in intervention group will receive 500 milligram curcumin supplements (1 per day) for 10 week. The curcumin supplements will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month).
Category
Treatment - Other

2

Description
Control group: Subjects in control group will receive placebo (1 per day) for 10 week. The placebo will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. The placebo will completely similar in appearance with curcumin supplements. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Heart Research Center
Full name of responsible person
Mohammadreza Sabri
Street address
Salman-e-Farsi street
City
Isfahan
Province
Isfehan
Postal code
81465-1148
Phone
+98 31 3611 5212
Email
pediatric.cardiovascular@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Masour Alavi
Street address
Hezar jarib street, Isfahan University of Medical sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3154
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Nourian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
Nourian@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Nourian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences school
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
Nourian@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saraf-Bank
Position
PhD student of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...