Protocol summary

Summary
(1) Objectives: The effect of cardamom supplementation on blood oxidative stress status and inflammatory factors in overweight and obese prediabetic women, (2) Design: This study is a randomized double blind clinical trial, (3) Setting and conduct: People selected from pre diabetic women referred to the tow health centers of Karaj city after getting a written informed consent and considering the inclusion and exclusion criteria, (4) Participants including major eligibility criteria: - Inclusion criteria: Having at least one of this criteria, FBS; 100-125 mg/dl, HbA1C: 5.7-6.4, 2hpp blood glucose: 140-199 mg/dl; Age: 30-70 years; BMI: 25-39.9 kg/m2; Having at least one of the following criteria: TG>150 mg/dl, Chol>200 mg/dl, LDL>100 mg/dl, HDL<50 mg/dl. -Exclusion criteria: Multi vitamin and anti oxidant supplements consumption during the intervention; Changes in diet or physical activity; Not intaking of more than 10% of supplements; Morbidity to diabetes during the intervention, (5) Intervention: 80 subjects randomly assign to tow groups (40 intervention and 40 control groups). Intervention group receives 3 gr of green cardamom daily and placebo group receives 3 gr of rusk powder from 3 capsules (1 gr) tree times a day with meals. Period of intervention is 2 months, (6) main outcome measures (variables): Anthropometric measurements are performed by standard methods. Systolic and diastolic blood pressure are measured before and after the intervention in fasting state. Blood sample is taken from patient and GR, SOD, Total Antioxidant Capacity, MDA, Protein Carbonyl, IL-6, hs-CRP and TNF-α is measured before and after the study. General questionnaire, 24h dietary recall and physical activity questionnaire (IPAQ short form) are completed before and after the intervention. People are followed up by phone each week. The study compliance will be assumed through counting consumed capsules.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042917254N3
Registration date: 2015-05-09, 1394/02/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-09, 1394/02/19
Registrant information
Name
Gity Sotoude
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3333
Email address
gsotodeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences Vice chancellor for research,Tehran University of Medical Sciences,The 5th floor,Qods St, Keshavarz Blvd , Tehran
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cardamom supplementation on blood oxidative stress status and inflammatory factors in overweight and obese prediabetic women
Public title
The effect of cardamom supplementation on blood oxidative stress status and inflammatory factors in prediabetic women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Prediabetic women with one of the following criteria: FBS; 100-125 mg/dl, HbA1C: 5.7-6.4, 2hpp blood glucose: 140-199 mg/dl; Age: 30-70 years; BMI: 25-39.9 kg/m2; Having at least one of the following criteria: TG>150 mg/dl, Chol>200 mg/dl, LDL>100 mg/dl, HDL<50 mg/dl; Willingness to participate in the study. Not included in the study: BMI<25 kg/m2 or BMI≥40 kg/m2; Following a specific diet for last three months; Professional athlete; Sensitivity to Cardamom (allergy); Pregnancy and lactation; Nutritional supplement and multi vitamin-mineral consumption at least 2 times a week in the last month; Medical history of gastrointestinal ulcers, kidney or gall stones; Medical history of coronary heart disease, cancer and MS; Blood pressure>130/80 mmHg; LDL>160 mg/dl; TG>300 mg/dl; Smoking. Exclusion criteria: Multi vitamin and anti oxidant supplements consumption during the intervention; Changes in diet or physical activity; Not intaking of more than 10% of supplements; Morbidity to diabetes during the intervention.
Age
From 30 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
6th floor, the main organization of Tehran University of Medical sciences, at the corner of Qods Stt, Keshvarz Blv
City
Tehran
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
93-01-161-25470-117279

Health conditions studied

1

Description of health condition studied
Pre diabetes
ICD-10 code
R73.0
ICD-10 code description
Impaired glucose tolerance Prediabetes

Primary outcomes

1

Description
GR activity
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting GR activity by using kits

2

Description
SOD activity
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting SOD activity by using kits

3

Description
Serum Total Antioxidant Capacity
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of Serum Total Antioxidant Capacity by using kits

4

Description
MDA Concentration
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting MDA Concentration by using kits

5

Description
Protein Carbonyl Concentration
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting Protein Carbonyl Concentration by using kits

6

Description
IL-6 Concentration
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting IL-6 Concentration by using kits

7

Description
hs-CRP Concentration
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting hs-CRP Concentration by using kits

8

Description
TNF-α Concentration
Timepoint
before and after the intervention
Method of measurement
Enzymatic Measurement of fasting TNF-α Concentration by using kits

Secondary outcomes

1

Description
Waist circumference
Timepoint
before and after the intervention
Method of measurement
measurement with a meter

2

Description
BMI
Timepoint
before and after the intervention
Method of measurement
Measured with formula

3

Description
Weight
Timepoint
before and after the intervention
Method of measurement
Measured with a digital scale

Intervention groups

1

Description
group receiving green cardamom :capsules containing 1g cardamom, three a day for 2 month
Category
Other

2

Description
placebo group receiving rusk powder: capsules containing 1g of rusk powder, three a day for 2 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers Imam Hussein
Full name of responsible person
Fatemeh Yaghooblou
Street address
104 St, Emam khomeini Blv, Mohammadshahr, Karaj
City
Karaj

2

Recruitment center
Name of recruitment center
Health Centers Vali-Asr
Full name of responsible person
Fatemeh Yaghooblou
Street address
Golestan 20 Alley, Anbar naft St, Malard Road, Karaj
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Yunesian
Street address
Vice chancellor for research,Tehran University of Medical Sciences,The 5th floor,Qods St, Keshavarz Blvd , Tehran
City
Tehran
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,Tehran 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
Tehran university of Medical Sciences
Full name of responsible person
Fatemeh Yaghooblou
Position
Student in MSPH
Other areas of specialty/work
Street address
No 44, Hojjat doost St, Naderi St, Keshavarz Blv, School of Nutritional Sciences and Dietetic,Tehran, Iran.
City
Tehran
Postal code
Phone
+98 26 3451 4381
Fax
Email
yaghooblou.fatemeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Dr. Sotoude
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
No 44, Hojjat doost St, Naderi St, Keshavarz Blv, School of Nutritional Sciences and Dietetic,Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5118
Fax
Email
gsotodeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of Medical Sciences, School of Nutritional Sciences and Dietetic
Full name of responsible person
Dr. Sotoude
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
No 44, Hojjat doost St, Naderi St, Keshavarz Blv, School of Nutritional Sciences and Dietetic,Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5118
Fax
Email
gsotodeh@tums.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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