The effects of melatonin supplementation on nutritional status, oxidative stress, metabolic and inflammatory parameters in obese women undergoing weight loss diet
In a double-blind randomized clinical trial 46 volunteer obese women will be recruited. Subjects will be randomly assigned into melatonin and placebo groups based on Permuted block randomization using the SAS software. Concurrent with weight loss diet two groups will receive daily 6 mg melatonin or 6 mg placebo 2 hours before bed time for 40 days.
General information and dietary intake of subjects will be collected by questionnaire and 24-hour dietary recall method respectively. After measuring of weight, height, waist and hip circumference, body mass index and waist to hip ratio will be calculated. After overnight fasting 10 ml blood samples will be collected. Serum glucose, insulin, leptin ,adiponectin, inflammatory and oxidative stress factors and lipid profiles will be determined at baseline and endpoint of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122411867N1
Registration date:2013-07-01, 1392/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Naimeh Mesri Alamdari
Name of organization / entity
Faculty of Health and Nutrition, Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
mesri65@gmail.com
Recruitment status
Recruitment complete
Funding source
Nutrition Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
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
The effects of melatonin supplementation on nutritional status, oxidative stress, metabolic and inflammatory parameters in obese women undergoing weight loss diet
Public title
The effect of melatonin supplementation on obesity management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Volunteer women with body mass index(BMI) =30 or more, aged between 20-50 years with maintained weight during the last six months
Exclusion criteria: Include pregnancy and lactation, menopause, smoking, alcohol consumption, having endocrine or kidney disease, depression, taking tranquilizers, contraceptives, anti- inflammatory, glucose and lipid- lowering drugs. Also taking any kind of antioxidant supplements in the last 3 months
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A double- blind procedure is used to prevent both experimenter bias and placebo effects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University Of Medical Sciences
Street address
Vice-chancellor for Research, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-04-15, 1392/01/26
Ethics committee reference number
Letter No: 612/4/5 Ethic code : 924
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
adiponectin
Timepoint
The onset and end of the study
Method of measurement
ELISA
2
Description
Glucose
Timepoint
The onset and end of the study
Method of measurement
Enzymatic colorimetric
3
Description
Insulin
Timepoint
The onset and end of the study
Method of measurement
Chemiluminescence
4
Description
high sensitive c- reactive protein
Timepoint
the onset and end of the study
Method of measurement
immunoturbidometry
5
Description
leptin
Timepoint
The onset and end of the study
Method of measurement
ELISA
6
Description
Nutritional status
Timepoint
The onset and end of the study
Method of measurement
Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer
7
Description
Total antioxidant capacity
Timepoint
The onset and end of the study
Method of measurement
Spectrophotometry
8
Description
LDL-C
Timepoint
The onset and end of the study
Method of measurement
Enzymatic colorimetric
9
Description
Total cholesterol
Timepoint
The onset and end of the study
Method of measurement
Enzymatic colorimetric
10
Description
Malondialdehyde
Timepoint
The onset and end of the study
Method of measurement
Spectrophotometry
11
Description
HDL-C
Timepoint
The onset and end of the study
Method of measurement
Enzymatic colorimetric
12
Description
Triglyceride
Timepoint
The onset and end of the study
Method of measurement
Enzymatic colorimetric
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: melatonin which is a natural hormone in the body and regulates sleep will be administered as oral supplement at a dose of 6 milligram (2 melatonin tablet, 3 mg each; made by Nature Made, USA) 2 hours before bed time for 40 days with weight loss diet.
Category
Treatment - Drugs
2
Description
Control group will receive 6 mg placebo ( 2 tablet, 3 mg each containing cellulose, silicon dioxide and starch) 2 hours before bed time for 40 days with weight loss diet.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The Clinics of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Mahdavi
Street address
Faculty of Health and Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tabriz University of Medical Sciences- Nutrition Research Center
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of Health and Nutrition, 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, Tabriz University of Medical Sciences- Nutrition Research Center
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
Faculty of Health and Nutrition, Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Ostadrahimi
Position
Ph.D in Nutrition science
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Attare Neishabouri street, Golgasht street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2295
Fax
Email
nut-rc@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Health and Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Mahdavi
Position
Ph.D. in Nutrition science
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Attare Neishabouri street, Golgasht street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
Email
Mahdavir@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Health and Nutrition, Tabriz University Of Medical Sciences
Full name of responsible person
Naimeh Mesri Alamdari
Position
MS.c student in Nutrition science
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Attare Neishabouri street, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)