Method of this study has designed based on Double blind Randomized Clinical Trial principles.the goal of this study is the Effects of combined administration of weight reducing diet and Zinc supplementation on anthropometric factors, Apelin and inflammatory markers in obese individual. in this study cases were chosen from obese patients(BMI ≥ 30 kg/m2) with no exclusion criteria.After completing informed consent form, obese patients will be requested to be fast for 12 to 14 hours in subsequent presence.then we will catch 5 cc venous blood from patients and they will be weighed with 100 grams precision and light clothing and will be calculated their stature without shoes with 0.5 cm precision and waist circumference and bioelectrical impedance analysis and their general characteristic will be record in data collecting sheet.then cases will be divided to two groups.one group (case group) will be received combined administration of weight reducing diet and zinc sulphate capsules and the other group (control group) will be received weight reducing diet and placebo. obese patients in case group will recieve 50 mg zinc daily during 15 weeks, while obese patients in control group will be recieve placebo capsules. At the end of seventh week of study, in all patients anthropometric indices, weight, waist circumference and body fat composition will be again calculated.At the end of the fifteenth week,5 cc blood after 12 to 14 hours fasting will be again catch from patients and anthropometric indices (weight, waist circumference and body fat composition) will be again recorded.finally blood samples will be santrifuge for15 minutes at 2000 rpm to separating serum component.then serum TNF-alpha, hs-CRP and Apelin will be measured with enzymatic method.In this study sample size according to standard deviation (SD) of previous studies and equality of variance in two groups based on formula for each group has calculated 15 patients that because of probable infusion, 25 patients in each group has considered
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072615968N2
Registration date:2015-09-01, 1394/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Atoosa Saidpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of nutrition
Country
Iran (Islamic Republic of)
Phone
-
Email address
a.saidpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Zinc supplementation on anthropometric factors, Apelin and inflammatory markers in obese individual
Public title
Effects of Zinc supplementation in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 45-18 years; non-smoking; body mass index above 30 kg/m2
Exclusion criteria: pregnancy; lactation; menopause in women; a history of liver disease; kidney disease; thyroid; diabetes and other metabolic diseases; drugs interfering with lipid profile; blood-thinning drugs; beta-blockers; patients with immune deficiency; zinc supplementation; calcium and iron in 2 months; use of weight loss drugs or diet; weight loss diet in the last 2 months; recent surgery
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
National Nutrition and Food Technology Research Institute
Street address
Tehran, qods(qarb) town,shahid farahzadi boulevard,shahid hafezi (west arqavan) street,7 tag
City
Tehran
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
055570
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E65, E66
ICD-10 code description
Localized adiposity, Obesity
Primary outcomes
1
Description
Body mass Index
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
calculating
2
Description
weight
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
Seca scale
3
Description
waist circumference
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
meter
4
Description
Hip circumference
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
meter
5
Description
waist circumference to hip ratio
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
calculating
6
Description
Body fat percentage
Timepoint
before intervention, seven weeks after intervention,fifteen weeks after intervention
Method of measurement
Bioelectrical Impedance Analysis
Secondary outcomes
1
Description
serum TNF-alpha concentration
Timepoint
before intervention,fifteen weeks after intervention
Method of measurement
Enzymatic method by kit
2
Description
hs-CRP concentration
Timepoint
before intervention,fifteen weeks after intervention
Method of measurement
Enzymatic method by kit
3
Description
Apelin concentration
Timepoint
before intervention,fifteen weeks after intervention
Method of measurement
Enzymatic method by kit
Intervention groups
1
Description
control group: obese patients in the control group receive a placebo daily for 15 weeks similar to sulfate capsule on the intervention group
Category
Placebo
2
Description
intervention group: Obese individuals in the intervention group received 50 mg of zinc sulfate for 15 weeks.
.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti university of medical sciences
Full name of responsible person
Hoda KHorsandi
Street address
tehran,garb town,baran street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr.Fatemeh Mohammadi Nasrabadi
Street address
Tehran, qods(qarb) town,shahid farahzadi boulevard,shahid hafezi (west arqavan) street,7 tag
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology 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
National Nutrition and Food Technology Research Institute
Full name of responsible person
Hoda Khorsandi
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
Tehran, qods(qarb) town,shahid farahzadi boulevard,shahid hafezi (west arqavan) street,7 tag
City
Tehran
Postal code
Phone
+98 21223574835
Fax
Email
hoda.khorsandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences- school of nutritio
Full name of responsible person
Dr. Atoosa Saidpour
Position
PHD of nutrition
Other areas of specialty/work
Street address
Tehran, qods(qarb) town,shahid farahzadi boulevard,shahid hafezi (west arqavan) street,7 tag
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
atoosa.saidpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Hoda Khorsandi sani
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
Tehran, qods(qarb) town,shahid farahzadi boulevard,shahid hafezi (west arqavan) street,7 tag
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)