Evaluation of the effects of Melatonin Supplementation on metabolic Syndrome components and plasma Leptin and Adiponectin levels in patients with metabolic Syndrome
Objectives: The metabolic syndrome is a collection of metabolic risk factors that increases the risk of cardiovascular disease, type 2 diabetes and some cancers. insulin resistance and accumulation of visceral fat are suggested as background. Melatonin is considered one of the strongest antioxidants in the body that improves insulin resistance and dyslipidemia. The main objective of this study is evaluation of the effects of Melatonin supplement on metabolic Syndrome components and plasma Leptin and Adiponectin levels in patients with metabolic Syndrome. Design: This study is a double blind randomized clinical trial. Blinding will be implemented on patients and researchers. 80 Patients with metabolic syndrome will be divided in two intervention (receiving Melatonin supplement) and placebo groups. Setting and conduct: The period of intervention is 12 weeks. Blood samples will be taken before and after of supplementation. Participants (including major eligibility criteria): Inclusion criteria will be age more than 18 years, waist circumference in men greater than or equal to 102 cm and in women greater than or equal to 88 cm and triglycerides levels greater than or equal to 150 mg/dL and exclusion criteria will be suffering from other liver diseases, cancer and autoimmune diseases. Intervention: One 5 mg Melatonin capsule per day in intervention group and one placebo capsule per day in placebo group for 12 weeks. Main outcome measures: metabolic Syndrome components and plasma Leptin and Adiponectin levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111016123N11
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Melatonin Supplementation on metabolic Syndrome components and plasma Leptin and Adiponectin levels in patients with metabolic Syndrome
Public title
Effects of Melatonin on Metabolic Syndrome disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 years and older; having at least two of the five metabolic syndrome criteria including waist circumference in men greater than or equal to 102 cm and in women greater than or equal to 88 cm; triglycerides levels (TG) greater than or equal to 150 mg/dL; low-density lipoprotein cholesterol levels (HDL-c) less than or equal to 40 mg/dL in men and less than or equal to 50 mg/dL in women; blood pressure greater than or equal to 130 mmHg or under treatment of Hypertension; fasting blood sugar greater than or equal to 100 mg/dL. b -exclusion criteria: history of alcohol consumption; chronic and acute liver disorders (hepatitis B, C, ...); biliary diseases; autoimmune diseases; cancer; cardiovascular diseases; pulmonary diseases; kidney diseases; pregnancy; breast-feeding; use of contraceptives; hepatotoxic drugs consumption; use of Mineral- multivitamin supplements; weight loss surgery in the recent year; weight loss program in 3 month ago; history of hypothyroidism; Cushing's syndrome.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
ٍEthics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.AJUMS.REC.1395.702
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere
Primary outcomes
1
Description
Triglyceride
Timepoint
before intervention and after 3 months
Method of measurement
serum level
2
Description
Total cholesterol
Timepoint
before intervention and after 3 months
Method of measurement
serum level
Secondary outcomes
1
Description
High density lipoprotein (HDL)
Timepoint
before intervention and after 3 months
Method of measurement
serum level
2
Description
Low density lipoprotein (LDL)
Timepoint
before intervention and after 3 months
Method of measurement
serum level
3
Description
Leptin
Timepoint
before intervention and after 3 months
Method of measurement
serum level
4
Description
Adiponectin
Timepoint
before intervention and after 3 months
Method of measurement
serum level
5
Description
fasting blood sugar
Timepoint
before intervention and after 3 months
Method of measurement
serum level
6
Description
blood pressure
Timepoint
before intervention and after 3 months
Method of measurement
Blood Pressure Monitor
7
Description
waist circumference
Timepoint
before intervention and after 3 months
Method of measurement
Tape measure
8
Description
sleep quality
Timepoint
before intervention and after 3 months
Method of measurement
questionnaire
Intervention groups
1
Description
Melatonin, Tab 5 mg, once a dayT 3 months
Category
Other
2
Description
Placebo, 5 mg, 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomieni Hospital
Full name of responsible person
Mina Bahrami
Street address
Emam Khomieni Hospital, Azadegan, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
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 and Technology, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Ph.D
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3336 7560
Fax
Email
sjafarirad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Ph.D
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3336 7560
Fax
00
Email
sjafarirad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina Bahrami
Position
BSc in Nutrition Science
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
mm.bahrami10@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)