Protocol summary

Summary
The purpose of this clinical trial is to evaluate the effect of green coffee extract supplementation on serum level of chemerin, malondialdehyde, nutritional status and metabolic status in patients with metabolic syndrome. Sample size is 44 person. This trial is a randomized, double-blind, placebo-controlled clinical trial. Blinding will be performed for patients and the study researchers. Subjects were randomly divided into intervention and control groups. Randomization is based on a random-number table. After meeting the inclusion and exclusion criteria, patients will allocated randomly (by random numbers table) into two intervention and control groups. At the beginning of the study, five ml of blood (after 8-12 hours of fasting) will be taken. After determining the persons to the intervention and control groups, a cloudy and closed envelopes will be used for allocation to two groups. For everyone in the envelopes, the capsule will be similar. The subjects will take two capsules (400 mg) daily with breakfast and lunch. Fasting blood was used for serum level of chemerin, lipid Parameters profile, fasting blood glucose, insulin, HbA1c and malondialdehyde. Blood pressure also was measured. The General Information Questionnaire, Anthropometric indices, physical activity questionnaire and appetite level questionnaire and 24-hour recall will be filled out in at the start of the intervention, the fourth week (for follow up) and the eighth week by the participants. They will be evaluated based on the following criteria: persons 50-25 years of age and with metabolic syndrome Exclusion criteria: the use of lipid lowering agents; weight loss medicines; the use of fasting blood glucose lowering agents; the use of antihypertension agents and addiction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081635736N1
Registration date: 2017-08-22, 1396/05/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
mehdi fasihi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4653 0325
Email address
fasihim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of green coffee extract supplementation on serum level of chemerin, malondialdehyde, nutritional status and metabolic status in people with metabolic syndrom
Public title
the effect of green coffee on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people with metabolic syndrome; 25-50 year old person; willingness to cooperate. Exclusion criteria: use of lipid or glucose or blood pressure lowering agents; use of body weight loss medications; Addiction and Smoking; Menopause; Sensitivity to placebo; cancer; cardiovascular disease; liver disorders; kidney disease and anemia; use of antioxidant supplements, fish oil supplements and alcohol; pregnancy and lactation
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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 Tabriz University of Medical Sciences
Street address
Ghol-Ghasht Ave, Azadi St, Tabriz
City
Tabriz
Postal code
Approval date
2016-09-26, 1395/07/05
Ethics committee reference number
IR.TBZMED.REC.1395.669

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
E66.0,E11.
ICD-10 code description
Obesity due to excess calories, Non-insulin-dependent diabetes mellitus with unspecified complications,Secondary hypertension, unspecified

Primary outcomes

1

Description
Serum Chemerin
Timepoint
At baseline and after 2 month of intervention
Method of measurement
ELISA

2

Description
Malondialdehyde
Timepoint
At baseline and after 2 month of intervention
Method of measurement
Spectrophotometry of Thiobarbituric Acid

Secondary outcomes

1

Description
whight
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
scale

2

Description
BMI
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
W/H.t2

3

Description
Waist circumference
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
Standard plastic tape

4

Description
Hip circumference
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
Standard plastic tape

5

Description
Waist/Hip ratio
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
Waist / Hip

6

Description
blood pressure
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
Standard mercury manometer

7

Description
Physical activity
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
The International physical activity questionnaire

8

Description
Triglyceride
Timepoint
Beginning of the study and after two months
Method of measurement
Enzymatic and colorimetric method

9

Description
Total Cholesterol
Timepoint
Beginning of the study and after two months
Method of measurement
Enzymatic and colorimetric method

10

Description
LDL-C
Timepoint
Beginning of the study and after two months
Method of measurement
Enzymatic and colorimetric method

11

Description
HDL-C
Timepoint
Beginning of the study and after two months
Method of measurement
Enzymatic and colorimetric method

12

Description
Fasting blood glucose
Timepoint
Beginning of the study and after two months
Method of measurement
Glucose oxidase enzymatic and colorimetric

13

Description
Insulin level
Timepoint
Beginning of the study and after two months
Method of measurement
Enzymatically using autoanalyzer

14

Description
Insulin resistance
Timepoint
Beginning of the study and after two months
Method of measurement
HOMAIR

15

Description
HbA1c
Timepoint
Beginning of the study and after two months
Method of measurement
Colorimetric - Ion Spectrophotometer

16

Description
Nutritional status
Timepoint
At baseine and 4th and 8th weeks
Method of measurement
The questionnaires and Software nutrition 4

Intervention groups

1

Description
Intervention group: patients will receive a daily two capsules containing 400 mg of green coffee extract, for two months. Capsules should taken 30 minutes before breakfast and lunch with glass of water.
Category
Treatment - Drugs

2

Description
control group: patients will receive a daily two placebo capsules , for two months. Capsules should taken 30 minutes before breakfast and lunch with a glass of water.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of nutrition Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali barzegar
Street address
East Azarbaijan, Tabriz, Golghast St, Tabriz University of Medical Sciences, Faculty of Nutrition and Health
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi, Research Assistant of Tabriz University of Medical Sciences
Street address
Ghol-Ghasht Ave.,Azadi St.,Tabriz.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Fasihi
Position
MSc. Student of Nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave.,Azadi St.,Tabriz.
City
Tabriz
Postal code
Phone
+98 930 636 1993
Fax
Email
fasihim@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mehdi fasihi
Position
msc.student of nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave., Azadi St.,Tabriz.
City
Tabriz
Postal code
Phone
+98 31 4653 0325
Fax
Email
fasihim@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi fasihi
Position
MSC student of nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave., Azadi St.,Tabriz.
City
Tabriz
Postal code
Phone
00
Fax
Email
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
Loading...