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The effect of green coffee extract supplement on anthropometric indices, lipid profile, oxidized LDL, serum high sensitivity C Reactive Protein and total antioxidant capacity of men with dyslipidemia

Protocol summary

Study aim
The effect of green coffee extract supplement on anthropometric indices, lipid profile, oxidized LDL, serum high sensitivity C Reactive Protein and total antioxidant capacity of men with dyslipidemia
Design
The controlled clinical trials, community-based and action-oriented, parallel group, double-blind, randomized,
Settings and conduct
The study was conducted on men with dyslipidemia in a petrochemical company. The study is a randomized double-blind clinical trial with two groups of drugs and placebo. All participants, researchers, data analyst, and project supervisor are blind.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- Having Dyslipidemia 2- Male 3- Age 25-55 Exit criteria: 1- No use of lipid lowering agent 2- Weight loss diet, vegetarianism, ... 3. No allergy or coffee addiction 4- Reduction or weight gain in 6 months the past
Intervention groups
Drug group: received capsules of green coffee extract. Placebo group: received capsules containing starch.
Main outcome variables
Anthropometric indices, lipid profiles, oxidized LDL, high sensitivity C reactive protein, total antioxidant capacity of serum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180128038540N1
Registration date: 2018-09-17, 1397/06/26
Registration timing: retrospective

Last update: 2018-09-17, 1397/06/26
Update count: 0
Registration date
2018-09-17, 1397/06/26
Registrant information
Name
Shekoufeh Salamat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5223 3609
Email address
shekooofeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2018-01-31, 1396/11/11
Actual recruitment start date
2018-01-29, 1396/11/09
Actual recruitment end date
2018-01-31, 1396/11/11
Trial completion date
2018-03-31, 1397/01/11
Scientific title
The effect of green coffee extract supplement on anthropometric indices, lipid profile, oxidized LDL, serum high sensitivity C Reactive Protein and total antioxidant capacity of men with dyslipidemia
Public title
The effect of green coffee extract on dyslipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having dyslipidemia male 25to55 age
Exclusion criteria:
Taking lipid lowering drugs weight loss diet vegetarian diet allergy or coffee addiction weight loss or weight gain in the last 6 months
Age
From 25 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 78
Actual sample size reached: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was performed using blocked randomization method. Using four blocks of A and B, each person was randomly assigned to one of two placebo or intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blend, the green tea extract and placebo supplement were named A and B by the company. The randomization was performed using a blocked randomization method. Using four blocks of A and B, each person was randomly assigned to one of two placebo or intervention groups. All participants, researchers, data analyst, and project supervisor are blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan٬ University Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.AJUMS.REC.1396.899

Health conditions studied

1

Description of health condition studied
Dyslipidemia
ICD-10 code
E78.9
ICD-10 code description
Disorder of lipoprotein metabolism, unspecified

Primary outcomes

1

Description
weight
Timepoint
before and after 8 weeks
Method of measurement
digital scale

2

Description
body fat percentage
Timepoint
before and after 8 weeks
Method of measurement
using body composition analyzer omron BF511

3

Description
Waist circumference
Timepoint
before and after 8 weeks
Method of measurement
using strip meter

4

Description
total cholesterol
Timepoint
before and after 8 weeks
Method of measurement
total cholesterol test on blood sample

5

Description
triglyceride
Timepoint
before and after 8 weeks
Method of measurement
triglyceride test on blood sample

6

Description
low density lipoprotein
Timepoint
before and after 8 weeks
Method of measurement
low density lipoprotein test on blood sample

7

Description
high density lipoprotein
Timepoint
before and after 8 weeks
Method of measurement
high density lipoprotein test on blood sample

8

Description
oxidised low density lipoprotein
Timepoint
before and after 8 weeks
Method of measurement
oxidised low density lipoprotein test on blood sample

9

Description
high sensitivity chronic phase reactive protein
Timepoint
before and after 8 weeks
Method of measurement
high sensitivity chronic phase reactive protein test on blood sample

10

Description
total antioxidant capacity
Timepoint
before and after 8 weeks
Method of measurement
total antioxidant capacity test on blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consumption of 400 mg capsules of green coffee extract twice a day for half an hour before lunch or dinner, for 8 weeks
Category
Other

2

Description
Control group: Taking placebo capsules containing 500 mg of starch, 2 times a day, half an hour before lunch and dinner for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arvand petrochemical company
Full name of responsible person
Majid Mohammad shahi
Street address
Site 3, Special Economic Zone
City
Bandar emam khomeini
Province
Khouzestan
Postal code
۶۳۵۳۱۳۱۱۱۱
Phone
+98 61 5212 6404
Email
shsalamat@arvandpvc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Zare javid
Street address
Golestan, Jundishapur University of Medical Sciences, Faculty of Paramedicine
City
Ahwaz
Province
Khouzestan
Postal code
6356111111
Phone
+98 61 5212 6404
Email
ahmaddjavid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Arvand Petrochemical Company
Full name of responsible person
Naghi Ghasemian azizi
Street address
Special Economic Zone, site3
City
Bandar Imam Khomeini
Province
Khouzestan
Postal code
61563111111
Phone
+98 61 5215 6404
Email
shsalamat@arvandpvc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arvand Petrochemical Company
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Mohammad shahi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
golestan Ave., Univesity Blvd
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3373 8253
Email
shahi334@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
arvand petrochemical company
Full name of responsible person
Shekoufeh Salamat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
site3, special economic zone
City
Bandar emam khomeini
Province
Khouzestan
Postal code
۶۳۵۳۱۳۱۱۱۱
Phone
+98 61 5223 3609
Fax
Email
shsalamat@arvandpvc.ir

Person responsible for updating data

Contact
Name of organization / entity
arvand petrochemical company
Full name of responsible person
Shekoufeh Salamat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
site3, special economic zone
City
Bandar emam khomeini
Province
Khouzestan
Postal code
6353131111
Phone
+98 61 5223 3609
Fax
Email
shsalamat@arvandpvc.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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