Protocol summary

Summary
Study Objective: The effect of decaffeinated green coffee on type II diabetes. Study design: randomized controlled double blind clinical trial. Study population: Main inclusion criteria: Diagnosis of type II diabetes, aged 45 to 60 years. Main exclusion criteria: Changes in medications or supplements, pregnancy, chronic kidney disease and hepatitis, neuromuscular disease, failure to follow with prescribed diets. Sample size: 50 people in each group, Random allocation will be done by using a table of random numbers. Intervention or interventions study: Decaffeinated Green Coffee Extract Capsules and placebo in terms of appearance is quite similar to drugs but they also contain cellulose. Two capsules per day, a half hour before breakfast, and a half hour before lunch with a glass of water. Intervention time: Phase 1 in two months, a period of two weeks to clean (wash out) and phase 2 in 2 months (4 months). The primary outcome or consequences of the study: weight, systolic blood pressure, diastolic blood pressure, 2hpp, glucose, triglycerides, HDL, waist circumference, LDL, cholesterol.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052928151N1
Registration date: 2016-08-15, 1395/05/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Farzad Roshanzamir
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8487
Email address
farzadroshanzam@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Fasa University of Medical Sciences Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of green decaffeinated coffee bean extract on type 2 diabetes mellitus: a randomized, double‐blind, placebo-controlled crossover trial
Public title
The effects of decaffeinated green coffee on type II diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of type II diabetes during the last two years, aged 45 to 60 years, no weight loss during the last 6 months (less than 1 kg), avoiding the use of tobacco and alcohol Exclusion criteria: any change in medications or supplements, pregnancy, chronic kidney and liver disease, neuromuscular disease, failure to follow the prescribed diet (if food records during the study show the energy intake of 300 calories less or more than the amount specified).
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Random allocation will be done by using a table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn sina square, Fasa University of Medical Sciences
City
Fasa
Postal code
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
IR.FUMS.REC.1394.56

2

Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ebe sina Square, Fasa University of Medical Sciences
City
Fasa
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.FUMS.REC.1394.50

3

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.MUI.REC.1395.3.226

Health conditions studied

1

Description of health condition studied
Type II Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
2HPP
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

2

Description
FBS
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

3

Description
Weight
Timepoint
Beginning and end of each phase
Method of measurement
Carriage scales

4

Description
Fetuin-A
Timepoint
Beginning and end of each phase
Method of measurement
ELISA

5

Description
TG
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

6

Description
Chol
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

7

Description
LDL
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

8

Description
HDL
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

9

Description
Insolin
Timepoint
Beginning and end of each phase
Method of measurement
ELISA

10

Description
HOMA-IR
Timepoint
Beginning and end of each phase
Method of measurement
Formola

11

Description
GOT
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

12

Description
GPT
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

13

Description
ALK
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

14

Description
Pr
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

15

Description
ALB
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

16

Description
Total billirobin
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

17

Description
Direct billirobin
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer colorimetric method

18

Description
blood pressure
Timepoint
Beginning and end of each phase
Method of measurement
manometer

19

Description
Waist circumference
Timepoint
Beginning and end of each phase
Method of measurement
Meter

20

Description
Polyphenols
Timepoint
Beginning, Middle and end of each phase
Method of measurement
ELISA

21

Description
HbA1C
Timepoint
Beginning and end of each phase
Method of measurement
Biochemical auto analyzer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Each Capsule contains 800 mg of decaffeinated green coffee extract and 50 percent chlorogenic acid . Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water.
Category
Treatment - Drugs

2

Description
Control group: Each Capsule contains 800 mg of celloluse. Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Soheila Ahmadzade
Street address
Shariati Hospital, Fasa
City
Fasa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Fasa University of Medical Sciences
Full name of responsible person
Zahra Bordbar
Street address
Ebne Sina Squre
City
Fasa
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, Fasa 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
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Nahid Moazam
Street address
Hezar Jarib St.
City
Isfahan
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, Isfahan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Farzad Roshanzamir
Position
PhD Student
Other areas of specialty/work
Street address
Ibn sina square, Fasa University of Medical Sciences
City
Fasa
Postal code
Phone
+98 71 5331 6300
Fax
Email
farzad.roshanzamer@yahoo.com; froshanzamer@gmail.com; farzadroshanzam@mail.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Seyed Moeteza Safavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3792 3168
Fax
Email
safavimorteza@nutri.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Farzad Roshanzamir
Position
Other areas of specialty/work
Street address
Ibn sina square, Fasa University of Medical Sciences
City
Fasa
Postal code
Phone
+98 71 5333 7816
Fax
Email
farzad.roshanzamer@yahoo.com; froshanzamer@gmail.com; farzadroshanzam@mail.mui.ac.ir
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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