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Effects of grape seed extract supplement on anthropometric measurements, serum lipids, inflammatory markers and neuropeptide Y in overweight or obese individuals

Protocol summary

Summary
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 Grape seed extract supplementation on anthropometric measurements, serum lipids, inflammatory markers and neuropeptide Y, in overweight or obese individuals (BMI ≥ 25 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 Grape seed extract capsules and the other group (control group) will be received weight reducing diet and placebo. Obese patients in case group will recieve three capsules with 100 mg Grape seed extract daily during 12 weeks, while obese patients in control group will be recieve placebo capsules. At the end of 6 week of study, in all patients anthropometric indices, weight, waist circumference and body fat composition will be again calculated. At the end of the 12 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 for 15 minutes at 2000 rpm to separating serum component. Then serum lipids, neuropeptide Y, TNF-alpha and hs-CRP 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 22 patients that because of probable infusion, 25 patients in each group has considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015073015968N3
Registration date: 2016-07-23, 1395/05/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-23, 1395/05/02
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/Drug Applied Research Center, Tabriz
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of grape seed extract supplement on anthropometric measurements, serum lipids, inflammatory markers and neuropeptide Y in overweight or obese individuals
Public title
Effects of grape seed extract supplement on anthropometric measurements, serum lipids, inflammatory markers and neuropeptide Y in overweight or obese individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Aged 20-50 years; Body mass index above 25 kg/m2 Exclusion criteria include: pregnancy, lactation; Menopause in women; History of liver disease; Kidney disease; Thyroid; Celiac; Diarrhea and Acute infection; Recent surgery; Weight loss diet in 6 months ago; Use of any drugs or supplements related to weight loss; Changes in body weight over three kilograms in 2 months ago; The use of Antioxidants supplementation in 3 months ago and Use of anticoagulants such as Aspirin,Warfarin.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
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 Beheshti University of Medical Sciences
Street address
7 Tag, Shahid Hafezi Street, Farahzadi Boulevard, Shahrak Gharb, Tehran
City
Tehran
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.SBMU.nnftri.Rec.1394.43

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, Six weeks after intervention,Twelve weeks after intervention
Method of measurement
calculating

2

Description
Weight
Timepoint
Before intervention, six weeks after intervention,Twelve weeks after intervention
Method of measurement
Seca scale

3

Description
Waist circumference
Timepoint
Before intervention, six weeks after intervention,Twelve weeks after intervention
Method of measurement
Meter

4

Description
Hip circumference
Timepoint
Before intervention, six weeks after intervention,Twelve weeks after intervention
Method of measurement
Meter

5

Description
Waist circumference to hip ratio
Timepoint
Before intervention, six weeks after intervention,Twelve weeks after intervention
Method of measurement
Calculating

6

Description
Body fat percentage
Timepoint
Before intervention, six weeks after intervention,Twelve weeks after intervention
Method of measurement
Bioelectrical Impedance Analysis

Secondary outcomes

1

Description
Hs-CRP concentration
Timepoint
Before intervent, twelve weeks after intervention
Method of measurement
Enzymatic method by kit

2

Description
Serum TNF-alpha concentration
Timepoint
Before intervent, twelve weeks after intervention
Method of measurement
Enzymatic method by kit

3

Description
Serum lipids concentration
Timepoint
Before intervent, twelve weeks after intervention
Method of measurement
Enzymatic method by kit

4

Description
NPY concentration
Timepoint
Before intervent, twelve weeks after intervention
Method of measurement
Enzymatic method by kit

Intervention groups

1

Description
Overweight and Obese individuals in the intervention group received 3 capsules of 100 mg of Grape seed extract for 12 weeks.
Category
Treatment - Drugs

2

Description
Patients in the control group received a placebo capsules similar to the Grape seed extract capsule for 12 weeks.
Category
Placebo

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
Maryam Parandoosh
Street address
Baran Street, Shahrak Gharb, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of medical sciences
Full name of responsible person
Dr.Fatemeh Mohammadi Nasrabadi
Street address
7 Tag, Shahid Hafezi Street, Farahzadi Boulevard, Shahrak Gharb
City
Tehran
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, Shahid Beheshti university of medical sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Drug Applied Research Center, Tabriz
Full name of responsible person
Dr.Hossein Babaei
Street address
Vice chancellor for research of Tabriz University of Medical Sciences,university street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center, Tabriz
Proportion provided by this source
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
Maryam Parandoosh
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
7 Tag, Shahid Hafezi Street, Farahzadi Boulevard, Shahrak Gharb
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
maryam.parandoosh@gmail.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
7 Tag, Shahid Hafezi Street, Farahzadi Boulevard, Shahrak Gharb
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
Maryam Parandoosh
Position
MS Student of Nutrition
Other areas of specialty/work
Street address
7 Tag, Shahid Hafezi Street, Farahzadi Boulevard, Shahrak Gharb
City
Tehran
Postal code
Phone
00
Fax
Email
maryam.parandoosh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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