The aim of this study is to determine the effect of herbal supplement containing 300 mg magnesium sulfate on lipid profile, insulin resistance and insulin secretion in overweight patients. Seventy six non-diabetic overweight volunteers with BMI >28 in kg/m2, general health in GI and cardiovascular system and non pregnant were included in a Randomized Double Blind Placebo-Controlled Clinical Trial, and received either placebo or a herbal supplement capsules containing 300 mg elemental magnesium (as magnesium sulfate -MgSO4-) daily, for 6 months. Metabolic control, lipid profile and magnesium status were determined at baseline and every three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110124756N2
Registration date:2015-11-26, 1394/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Nepton Soltani
Name of organization / entity
Hormozgan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 913 325 1067
Email address
nsoltani@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Science
Expected recruitment start date
1991-03-03, 1369/12/12
Expected recruitment end date
1993-01-01, 1371/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevention effect of herbal mg supplement in insulin resistance in high fat patients
Public title
Effect of magnesium on insulin resistance prevention
Purpose
Prevention
Inclusion/Exclusion criteria
BMI>28, general health in GI and cardiovascular system morbility, non diabetic, non pregnant, normotensive and no dietary restrictions or allergies, no history of food allergy or sensitivity to Mg supplements
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Hormozgan University of Medical science
Street address
Emam Hossein Blv. Faculty of Medicineو Hormozgan University of Medical Science
City
Bandar Abbasa
Postal code
Approval date
2013-03-07, 1391/12/17
Ethics committee reference number
1394.57
Health conditions studied
1
Description of health condition studied
Insulin resistance
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Before intervention and every three months after intervention
Method of measurement
kit mg/dl
2
Description
Homa-IR
Timepoint
Before intervention and every three months after intervention
Method of measurement
HOMA–IR = FBG (mg/dl) × FPI (µu/ml) ∕ 405)
Secondary outcomes
1
Description
Insulin
Timepoint
Before intervention and every three months after intervention
Method of measurement
Kit µu/ml
2
Description
Lipid profiles
Timepoint
Before intervention and every three months after intervention
Method of measurement
Kit mg/dl
Intervention groups
1
Description
Herbal MgSO4 For Mg-treated- group
Category
Prevention
2
Description
Placebo for control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Molecular Research center
Full name of responsible person
Nepton Soltani
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Dr Abdol Azim Nejatizadeh
Street address
Hormozgan University of Medical Science
City
Bandar abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Science
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
Hormozgan University of Medical Science
Full name of responsible person
Nepton Soltani
Position
PhD
Other areas of specialty/work
Street address
Hormozgan University of Medical Science
City
Bandar Abbas
Postal code
Phone
+98 76 3362 0876
Fax
Email
solnep2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Nepton Soltani
Position
PhD
Other areas of specialty/work
Street address
Hormozgan University of Medical Science
City
Bandar Abbas
Postal code
Phone
+98 76 3362 0876
Fax
Email
solnep2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Nepton Soltani
Position
PhD
Other areas of specialty/work
Street address
Faculty of Meicine
City
Bandar Abbas
Postal code
Phone
+98 76 3362 0876
Fax
+98 76 3333 7193
Email
solnep2002@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)