Protocol summary

Summary
This is an interventional study with the goal of evaluation of the effect of calorie restricted diet adjunctive with green coffee been extract supplementation on some metabolic factors, anthropometric measures, plasma free fatty acids, visceral fat indiceand serum adipocytokins in obese wome. The Inclusion criteria is females, age 20-45 years, Before menopause, fat mass index more of the equal with 7.8 and 9.9 in ages 20-34 and 35-45 and willingness to cooperate in the study and the exclusion criteria is being under weight loss in 6 months, pregnancy, lactation, menopause, endocrine diseases, cardiovascular disease, liver disease, kidney disease, Thyroid disease, consumption of steroids drugs and Hormone therapy and intake of multivitamin or mineral or antioxidan complete. In this study 7 days food record will use to evaluate the dietary intake. Obese cases selected based on fat mass index and will be under the 8-week treatment period. In case group the subjects will be under the intake of green coffee been extract supplementation adjunctive with calorie restricted diet and the control group will be under the intake of placebo adjunctive with calorie restricted diet. metabolic factors and anthropometric measures will be measured at the first and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081910181N7
Registration date: 2015-09-26, 1394/07/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-26, 1394/07/04
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
The present study will be supported by a grant from the Vice‑chancellor for Research Ahvaz Jondishapoor University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of calorie restricted diet adjunctive with green coffee been extract supplementationonsome metabolic factors, anthropometric measures, plasma free fatty acids, visceral fat indiceand serum adipocytokins in obese women.
Public title
The effect of calorie restricted diet adjunctive with green coffee bean extract on obesity and inflamation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: females; age 20-45 years; Before menopause; fat mass index More of the equal with 7.8 and 9.9 in ages 20-34 and 35-45; Willingness to cooperate in the study the Exclusion criteria: Being under weight loss in 6 months; pregnancy; lactation; menopause; Endocrine diseases; cardiovascular disease; liver disease; kidney disease; Thyroid disease; consumption of Steroids drugs and Hormone therapy; intake of multivitamin or mineral or antioxidan complete
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jondishapoor University of Medical Sciences
Street address
Ahvaz Jondishapoor University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
ir.ajums.rec.1394.256

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Fat Mass Index
Timepoint
The beginning and end of the study
Method of measurement
Body Composition Analyser

2

Description
Visceral Fat
Timepoint
The beginning and end of the study
Method of measurement
Calculation

3

Description
Free Faty Acid
Timepoint
The beginning and end of the study
Method of measurement
Blood test

4

Description
Plasma leptin
Timepoint
The beginning and end of the study
Method of measurement
Blood test

5

Description
Adiponectin
Timepoint
The beginning and end of the study
Method of measurement
Blood test

6

Description
Total Cholesterol
Timepoint
The beginning and end of the study
Method of measurement
Blood test

7

Description
LDL Cholesterol
Timepoint
The beginning and end of the study
Method of measurement
Blood test

8

Description
HDL Cholesterol
Timepoint
The beginning and end of the study
Method of measurement
Blood test

9

Description
Triglycerides
Timepoint
The beginning and end of the study
Method of measurement
Blood test

10

Description
Blood Glucose
Timepoint
The beginning and end of the study
Method of measurement
Blood test

11

Description
Plasma Insulin
Timepoint
The beginning and end of the study
Method of measurement
Blood test

Secondary outcomes

1

Description
Blood Pressure
Timepoint
The beginning and end of the study
Method of measurement
Pressure indicatore

2

Description
Waist Circumference
Timepoint
The beginning and end of the study
Method of measurement
measurment

Intervention groups

1

Description
400 mg Green Coffee bean extract one in day 8 weeks
Category
Treatment - Drugs

2

Description
placebo 1 gr one in day 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Majid Mohamadshahi diet therapy clinic
Full name of responsible person
Mehnoosh Samadi
Street address
Golestan Highway, Ahvaz Jondishapoor University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences, Ahvaz, Iran.
Full name of responsible person
Dr Nader Saki
Street address
Golestan Highway, Ahvaz Jondishapoor University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapoor University of Medical Sciences, Ahvaz, Iran.
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
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jondishapoor University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
mehnoosh_samadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
PhD in Nutrition
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jondishapoor University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
haidari58@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jondishapoor University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
mehnoosh_samadi@yahoo.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
Loading...