Protocol summary

Summary
In this parallel randomized controlled trial, 70 hypertensive men and women with type 2 diabetes will be recruited from Institute of Endocrinology & Metabolism of Iran University of Medical Sciences. The subjects will be 35-65 years old with established and stably-treated type 2 diabetes mellitus for at least 1 year. Inclusion criteria are BMI≤40 kg/m2, HbA1C<9%, Blood pressure ≥ 130/80 mmHg and no regular use of any drugs or supplements with antioxidative (β-carotene, vitamins C or E) or lipid-lowering properties. All volunteers will either life-long nonsmokers or reported smoking abstinence of at least 5 years before study and they also will not use alcohol and drugs. Exclusion criteria are being allergic to chocolate, congestive heart failure, malignancies, chronic kidney, hepatic and thyroid diseases, severe cardiac arrhythmias, inflammation, using insulin, following vegetarian or weigh-reducing diets. Participants enrolled for the study would be allowed to continue their normal, daily lifestyle and eating habits. Prior to the study, the subjects will be required to complete 3-days 24-hour dietary recall and Diets will be analyzed for calorie, macronutrients and antioxidant content. Participants will consume 25 g daily of either white chocolate (without flavanol) or dark chocolate (with flavanol) for 8 weeks. Blood samples will be obtained after an overnight fasting before and after the study. All anthropometric and physical activity variables and blood pressure will be measured both before and after the trial and also Serum lipids, ApoB, ApoA-1, hsCRP , fasting blood glucose ,HbA1c and blood were measured at baseline and after 8 wks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812222602N3
Registration date: 2010-03-13, 1388/12/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-03-13, 1388/12/22
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Iran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-10, 1389/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dark chocolate consumption on ApoB, ApoA-1, lipid profile, hsCRP, glycemic control and blood pressure in type 2 Diabetec patients with hypertention.
Public title
Effect of Dark chocolate consumption in hypertensive type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being volunteer or wishing to attend, 35-65 y old, diagnosed with type 2 diabetes for at least 1 year (FPG ≥ 126 mg/dl or 2hPG ≥ 200 mg/dl), BMI ≤ 40 kg/m2, HbA1C < 9%, Blood pressure ≥ 130/80 mmHg and no regular use of any drugs or supplements with antioxidative (β-carotene, vitamins C or E) or lipid-lowering properties. Exclusion criteria: Allergy to chocolate, Taking insulin, Smoking cigarette, drinking alcohol or drug abuse, congestive heart failure, malignancies, chronic kidney , hepatic and thyroid diseases , severe cardiac arrhythmias, inflammation following vegetarian or weight-reducing diet 2 months before the study ,Changing medication dosage or physical activity level 2 mo before or during the study.
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Health, Iran University of Medical Sciences
Street address
Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Approval date
2010-07-18, 1389/04/27
Ethics committee reference number
1421

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Decrease Low Density Lipoprotein
Timepoint
8 weeks
Method of measurement
Laboratory kit

2

Description
decrease blood pressure
Timepoint
8 week
Method of measurement
sphygmomanometer

3

Description
decrease Apo B
Timepoint
8 weeks
Method of measurement
immunoturbidimetry

4

Description
increase ApoA-1
Timepoint
8 weeks
Method of measurement
immunoturbidimetry

5

Description
Decrease Triglyceride (TG)
Timepoint
8 weeks
Method of measurement
Laboratory Kit

6

Description
Decrease Fasting Blood Sugar (FBS)
Timepoint
8 weeks
Method of measurement
Enzymatic

7

Description
Decrease high sensitivity C-reactive protein (hs-CRP)
Timepoint
8 weeks
Method of measurement
Immunoturbidimetry

8

Description
decrease HbA1C
Timepoint
8 weeks
Method of measurement
Laboratory Kit

Secondary outcomes

empty

Intervention groups

1

Description
control: 25 gr of white chocolate for 8 weeks
Category
Other

2

Description
intervention: 25 gr of dark chocolate for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Endocrinology & Metabolism of Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohsen Asadi Lari
Street address
Hemmat high Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shahriar Eghtesadi
Position
Full Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shahriar Eghtesadi
Position
Full Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Shahriar Eghtesadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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