Effect of green coffee extract supplementation on glycemic control, insulin resistance, lipid profile, advanced glycation end products, inflammatory and oxidant status in overweight/obese patients with type 2 diabetes : a randomized double-blind clinical trial
Effect of green coffee extract supplementation on glycemic control, insulin resistance, lipid profile, advanced glycation end products, inflammatory and oxidant status in overweight/obese patients with type 2 diabetes
Design
Clinical trial with control group, with parallel group, double blind, randomised, on 44 patients with type 2 diabetes
Settings and conduct
In this study, 44 patients with type 2 diabetes will be select in Taleghani hospital then they divide in two groups (intervention and placebo group). They will be followed up for 10 weeks. All group allocation is blind for the
investigators and subjects
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects aged 35-70 years old; no specific diet; body mass index 25-35 kg/m2. Exclusion criteria: hepatic and renal; taking antioxidants and multivitamins-minerals supplementation.
Intervention groups
In the intervention group, subjects receive green coffee extract supplementation
In the control group, subjects receive placebo
Main outcome variables
Blood glucose and insulin
Triglycerides, low density lipoprotein, high density lipoprotei, total cholesterol
Carboxymethyl lysine
Malondialdehyde
High-sensitivity C-reactive Protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090203001640N18
Registration date:2020-06-14, 1399/03/25
Registration timing:prospective
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green coffee extract supplementation on glycemic control, insulin resistance, lipid profile, advanced glycation end products, inflammatory and oxidant status in overweight/obese patients with type 2 diabetes : a randomized double-blind clinical trial
Public title
Effect of green coffee extract supplementation in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement to participate in the study and completing informed consent form
Subjects aged 35-70 years old
Body mass index between 25-35 kg/m2
Fasting blood glucose ≥ 126 mg/dl or 2-h plasma glucose ≥200 mg/dl or treatment with anti-hyperglycemic medications
Exclusion criteria:
Following any specific diet in past three months
Pregnant and lactating women
Insulin treatment
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups Participants were randomly assigned to intervention or control group in the random blocks based on the random number table.The sequence of permuted blocks was generated with a random number table. An individual with no clinical involvement in the trial, put the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who was not aware of random sequences and the envelope content, assigned the patients to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed as a double blind study. The subjects, main investigator and outcome assessor are not aware of each patient's treatment assignment and the main investigator is not involved in the randomization process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
national nutrition and food technology research institute
Street address
No. 7, Shahid Hafezi Ave, Shahid frahzadi Blv, Tehran
City
Tehra
Province
Tehran
Postal code
1985717413
Approval date
2020-05-13, 1399/02/24
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1399.007
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At the beginning and end of the study
Method of measurement
Enzymatic /kit
2
Description
Plasma insulin
Timepoint
At the beginning and end of the study
Method of measurement
ELISA
3
Description
Plasma triglyceride
Timepoint
At the beginning and end of the study
Method of measurement
Enzymatic /kit
4
Description
Malondialdehyde
Timepoint
At the beginning and end of the study
Method of measurement
Colorimetric
5
Description
Carboxymethyl lysine
Timepoint
At the beginning and end of the study
Method of measurement
ELISA
6
Description
High-sensitivity C-reactive protein
Timepoint
At the beginning and end of the study
Method of measurement
ELISA
Secondary outcomes
1
Description
Body mass index
Timepoint
At the beginning and end of the study
Method of measurement
Weight in kilograms divided by height in meters squared
2
Description
Systolic blood pressure
Timepoint
At the beginning and end of the study
Method of measurement
Mercury sphygmomanometer
3
Description
Diastolic blood pressure
Timepoint
At the beginning and end of the study
Method of measurement
Mercury sphygmomanometer
Intervention groups
1
Description
Intervention group: Received 400 mg green coffee supplement two times a day orally for two months
Category
Treatment - Other
2
Description
Control group: Placebo group: Received 400 mg starch capsule two times a day for two months