Determining the effect of green coffee supplement on glycemic control, oxidative stress indices, lipid profile and anthropometry in type 2 diabetes
Design
Clinical trial with control group, with parallel groups,single-blind, randomized, phase two on 60 patients, Block Randomization method was used for randomization by Random Allocation Software
Settings and conduct
Patients were selected from Krooni and Mehregan clinicsin Shiraz. demographic information, medical and pharmacological history of individuals along with their height and weight information were recorded. IPAQ and 24-hour food recall questionnaires were taken. 5 cc of blood was also taken. Patients in the intervention group received 800 mg of green coffee extract daily for 8 weeks. Patients in the placebo group also received two placebo tablets daily. At the end of the fourth and eighth weeks,Questionnaires were filled and Blood samples were taken
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definitive diagnosis of type 2 diabetes in a fellow clinician under ADA criteria
Age 40 to 69 years
Duration of type 2 diabetes is at least 3 years
Willingness to participate in the study
No allergies to green coffee
The type and dose of drugs used in the last 6 months is constant
Non-pregnancy and lactation no chronic disease
Do not use any dietary supplements in the last 6 months
Exclusion criteria:
Pregnancy during the study period
Changes in medication dosage during the study period
Do not take less than 80% of the allocated amount of tablets or do not follow the study design for more than a week
Intervention groups
The intervention group received a green coffee supplement containing 50% chlorine and the control group received a placebo made by the same company with exactly the same appearance.
Main outcome variables
Glycemic status, Inflammatory markers, Oxidative stress, Lipid profile and anthropometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048232N1
Registration date:2020-08-03, 1399/05/13
Registration timing:retrospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Zahra Moein jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 2970
Email address
niloufarmoein@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2018-11-22, 1397/09/01
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2020-01-25, 1398/11/05
Scientific title
The effect of green coffee supplement on glycemic control, inflammatory index, lipid profile and anthropometry in type 2 diabetic patients
Public title
The effect of green coffee supplement on diabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of type 2 diabetes in patients was made by an associate clinical physician under ADA criteria.
Duration of type 2 diabetes is at least 3 years
The type and dose of drugs used in the last 6 months is constant
No chronic (chronic, renal, hepatic, pulmonary, or chronic or acute inflammatory diseases, especially acute inflammation of the pancreas and endocarditis)No heart disease, short bowel syndrome, allergies and thyroid disease
Do not use any dietary supplements in the last 6 months
No pregnancy and lactation
Willingness to participate in the study
No allergies to green coffee
Exclusion criteria:
Pregnancy during the study period
Changes in medication dosage during the study period
Occurrence of one of the above diseases during the study period
Dissatisfaction with continuing to participate in the study
Do not take less than 80% of the allocated amount of green coffee tablets or do not follow the study design for more than a week
Age
From 40 years old to 69 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned to one of the intervention and placebo groups based on Block Randomization method by Random Allocation Software
Blinding (investigator's opinion)
Single blinded
Blinding description
By preparing a placebo exactly like the supplement consumed, the participants did not know which of the groups they were in
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No270.40.Bahonar jonobi
City
shiraz
Province
Fars
Postal code
7177916419
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
IR.SUMS.REC.1398.585
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11.8
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications
Primary outcomes
1
Description
Blood Glu
Timepoint
at the first and end of the study
Method of measurement
Fasting blood glucose by glucose oxidase method
Secondary outcomes
1
Description
weight
Timepoint
First week 4 and week 8 study
Method of measurement
Weight of people in light clothing without shoes and in the fasting state was measured by a digital scale (model 703 Seka) with an accuracy of 100 grams.
2
Description
Insulin sensitivity
Timepoint
at the first and end of the study
Method of measurement
HOMA Homeostasis
3
Description
lipid profile
Timepoint
at the first and end of the study
Method of measurement
Triglycerides, cholesterol and LDL by enzymatic and calorimetric methods using Roach II commercial kits, HDL by calorimetric enzymatic method using Cubas Roach commercial kits
4
Description
insulin sensitivity
Timepoint
at the first and end of the study
Method of measurement
Insulin was evaluated by chemiluminescence method (40). Insulin concentration was determined using the ELISA kit of the American company Monobind. Also, insulin resistance and its components were calculated using the HOMA Homeostasis Model (Index assessment) before and after the intervention as follows: Fasting insulin (microu / L) x fasting glucose (nmol / L) /22.5
5
Description
total antioxidant
Timepoint
at the first and end of the study
Method of measurement
The Ferric Reducing Ability of Plasma method was determined using the main ingredient tripyridyl-S-triazine. Total antioxidant capacity was measured using 40 mM hydrochloric acid, 3-aqueous, 6-aqueous sodium acetate and triazine solution at concentrated Fecl acetic acid at 593 nm.
Intervention groups
1
Description
Intervention group:Take 800 mg of green coffee supplement daily, two 400 mg tablets daily
Category
Treatment - Other
2
Description
Control group: Receive two placebos daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kroni Clinic
Full name of responsible person
Zahra MoeinJahromi
Street address
Shiraz, Kroni region, Kroni clinic
City
Shiraz
Province
Fars
Postal code
7177916419
Phone
+98 71 3825 2970
Email
niloufarmoein@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
no name
Street address
Shiraz Zand St. Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohre mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shiraz Razi Blvd. School of Nutrition
City
Siraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
zohreh.mazloom@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Moein jahromi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shiraz Razi Blvd. School of Nutrition
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
niloufarmoein@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Moein Jahromi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shiraz Razi Blvd. School of Nutrition
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
۹۸۷۱۳۲۳۰۵۴۱۰+
Email
niloufarmoein@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Part of the data, such as information about the main outcome
When the data will become available and for how long
1399
To whom data/document is available
If a similar study is performed
Under which criteria data/document could be used
evryone
From where data/document is obtainable
Zahra Moin Jahromi
09228031953
Postal code
7177916419
What processes are involved for a request to access data/document