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Effects of resveratrol on mood , cognitive function and serum BDNF in patients With type 2 diabetes

Protocol summary

Summary
Objectives: To determine effects of resveratrol on mood, cognitive function and serum BDNF in patients with type 2 diabetes. Design: Randomized double-blind placebo-controlled clinical trial. Participants: Patients with type 2 diabetes with a minimum score of 10 in Beck Depression Inventory. Setting and conduct: Sixty eligible patients with type 2 diabetes will be referred form Institute of Endocrinology and metabolism, Firoozgar Hospital. Thy will be randomly assigned into two groups to receive daily either 240 mg resveratrol or placebo for 8 weeks. Mood and cognitive performance will be assessed at baseline and after weeks 4 and 8. 10 cc fasting venous blood samples will be obtained at the beginning and end of intervention and serum BDNF will be measured by ELISA. In order to control confounding factors, height, weight, food intakes, physical activity, age, sex, FBS, HbA1c and medications will be assessed before and after intervention. Intervention: 240 mg resveratrol or placebo. Main outcome measures: mood, cognitive function, serum BDNF.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411112394N14
Registration date: 2015-08-18, 1394/05/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-18, 1394/05/27
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resveratrol on mood , cognitive function and serum BDNF in patients With type 2 diabetes
Public title
Effects of resveratrol on mood and cognition in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of type 2 Diabetes for at least 2 years; willing to participate; a minimum score of 10 in Beck Depression Inventory; age between 45 to 70 years old. Exclusion criteria: Significant diseases including cardiovascular, renal and liver diseases, or cancer; pregnancy; lactation; consumption of antidepressant agents within the past 8 weeks; insulin use; consumption of nutritional supplements within the past 8 weeks.
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethic committee of Iran university of medical science
Street address
Iran University of Medical Sciences, Shahid Hemmet Highway, Tehran, Iran
City
Tehran
Postal code
14665-1579
Approval date
2014-06-17, 1393/03/27
Ethics committee reference number
93-03-27-25010

Health conditions studied

1

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

Primary outcomes

1

Description
Mood
Timepoint
At baseline and after weeks 4 and 8
Method of measurement
Beck Depression Inventory

2

Description
Cognitive performance
Timepoint
At baseline and after weeks 4 and 8
Method of measurement
Questionnaire

3

Description
Serum BDNF(brain-derived neurotrophic factor )
Timepoint
At baseline and after 8 weeks
Method of measurement
ELISA

Secondary outcomes

1

Description
HbA1c
Timepoint
At baseline and after 8 weeks
Method of measurement
Biochemical Assessment

2

Description
Fasting Blood Sugar
Timepoint
At the begining and end(week 8) of intervention
Method of measurement
Biochemical measurements

Intervention groups

1

Description
Resveratrol- 240 mg/day for 8 week
Category
Treatment - Other

2

Description
Placebo-240mg/day for 8 week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism, Firouzgar Hospital, Iran University of Medical Sciences
Full name of responsible person
Dr. Iraj Heidari
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Science
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Iran University of Medical Science, Shahid Hemmat Highway
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, Iran University of Medical Science
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
Department of Nutrition, School of Public Health, Iran University of Medical Sciences.
Full name of responsible person
Fahime Ahmadi Motlaq
Position
Student of MSc Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, ُSchool of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8862 2806
Fax
Email
ahmadi.f@tak.iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Sciences
Full name of responsible person
Dr Shima Jazayeri
Position
MD, PhD
Other areas of specialty/work
Street address
Department of Nutrition, ُSchool of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
jazayeri.sh@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Sciences
Full name of responsible person
Fahime Ahmadi Motlaq
Position
MSc Student of nutrition
Other areas of specialty/work
Street address
Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 910 680 9477
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
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Analytic Code
empty
Data Dictionary
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