The effect of Dietary Approaches to Stop Hypertension (DASH) diet on mental health, sleep, sexual hormones and advanced glycated end products (AGEs) serum levels among type 2 diabetic women: A clinical trial study
Effect of DASH diet on psychological and sleep status, sexual hormones and AGEs levels
Design
This study is a parallel clinical trial in 60 postmenopause and diabetic patients. These subjects divided into intervention and control group as follows: Intervention group: 30 postmenopause women with type 2 diabetes in DASH diet.
Control group: 30 postmenopause women with type 2 diabetes in the usual diet.
Settings and conduct
We will perform run-in period 2 weeks before starting the trial. Characteristics information, physical activity and food records, PSQI and DASS-21 questionnaires will be filled before and at the end of the trial. Also, anthropometric indices, blood pressure, biochemical factors including FBS, HbA1c, SHBG, LH, FSH, AGEs, testosterone, Urine 24h sodium, and potassium will be measured. Two group (n=30) of participants will receive DASH or usual diet for 12 weeks. Finally, ANOVA and ANCOVA test, also chi-square test will be used for continuous and categorical variables, respectively.
Participants/Inclusion and exclusion criteria
The tendency to participate in the study, patients with type 2 diabetes and who are postmenopause and don't adhere a specific diet are inclusion criteria.
The exclusion criteria are as follows: cancer, kidney, liver, heart, psychological disorders and other diseases, any new events which impact on patients mood, consumption of OCPs, hormonal drugs, and hormone therapy. estrogen therapy for 3 last months. smoking. Insulin therapy and consumption of any supplement and vitamin during 2 last months.
Intervention groups
Intervention group: 30 postmenopause women with type 2 diabetes in DASH diet
Control group: 30 postmenopause women with type 2 diabetes in the usual diet
Main outcome variables
Stress, Anxiety, and depression
Sleep status
Sexual hormones in serum
Advanced GLycated End Products in serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180312039055N1
Registration date:2018-05-20, 1397/02/30
Registration timing:prospective
Last update:2018-05-20, 1397/02/30
Update count:1
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Elnaz Daneshzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
e-daneshzad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dietary Approaches to Stop Hypertension (DASH) diet on mental health, sleep, sexual hormones and advanced glycated end products (AGEs) serum levels among type 2 diabetic women: A clinical trial study
Public title
DASH diet in diabetes complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in the study
Patients with type 2 diabetes
Postmenopause individuals (who don't have the period cycle for 12 months)
Perrsons who dont adhere special diets
Exclusion criteria:
Patients with cancer, kidney, liver, heart and other specific diseases, patients with depression and other psychological diseases, New events which impact on patients mood
Consumption of OCPs, hormonal supplements and hormone therapy
Esterogen therapy during 3 last months
Smoking
Insulin therapy
Consumption of supplements and vitamins during 2 last months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants divide into control (n= 30) and intervention (n= 30) groups using randomized number table. Then, individuals block according to age and body mass index. This study is diet therapy and doesn't have concealing processing.
Blinding (investigator's opinion)
Not blinded
Blinding description
The intervention is diet therapy, therefore we have no concealing process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
دانشگاه علوم پزشکی تهران
Secondary trial Id
96-04-161-36923
Registration date
2018-04-11, 1397/01/22
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
Tehran University of Medical Sciences Research Center, Qods Ave, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1416643931
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.TUMS.VCR.REC.1397.4937
Health conditions studied
1
Description of health condition studied
Diabetes complication including stress, anxiety and depression, sleep, sexual hormones and AGEs
ICD-10 code
E10-E14
ICD-10 code description
E10-E14
Primary outcomes
1
Description
LH
Timepoint
Before and after intervention (12wk)
Method of measurement
ELIZA
2
Description
FSH
Timepoint
Before and after intervention (12wk)
Method of measurement
ELIZA
3
Description
SHBG
Timepoint
Before and after intervention (12wk)
Method of measurement
ELISA
4
Description
Testestrone
Timepoint
Before and after intervention (12wk)
Method of measurement
ELIZA
5
Description
AGEs
Timepoint
Before and after intervention (12wk)
Method of measurement
ELIZA
6
Description
Stress, anxiety and depression
Timepoint
Before and after intervention (12wk)
Method of measurement
DASS-21 item questionniare
7
Description
Sleep status
Timepoint
Before and after intervention (12wk)
Method of measurement
PSQI
Secondary outcomes
1
Description
Weight and BMI
Timepoint
Before and after intervention (12 wk)
Method of measurement
Scale
2
Description
Waist circumference
Timepoint
Before and after intervention (12 wk)
Method of measurement
Using an inflexible meter
3
Description
Blood pressure
Timepoint
Before and after intervention (12 wk)
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention group: Postmenopausal diabetic patients who adhere DASH diet
Category
Treatment - Other
2
Description
Control group: Postmenopausal diabetic patients who adhere usual diet
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine & Metabolism Research Institute
Full name of responsible person
Bagher Larijani
Street address
North Kargar Ave, Shahrivar Ave, First Intersection, Next to Heart Center
City
Tehran
Province
Tehran
Postal code
88220038
Phone
+98 21 8822 0038
Email
info@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Rostamabadi
Street address
Research Center of TUMS. Qods Ave. Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
81633610
Phone
+98 21 8163 3610
Email
e-daneshzad@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Leila Azadbakht
Position
PhD in Nutrition, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and dietetics faculty, No 44, Hojjatdoost alley, Naderi Ave, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Email
azadbakhtleila@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Leila Azadbakht
Position
Ph.D. in Nutrition, Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and dietetics faculty, No 44, Hojjatdoost alley, Naderi Ave, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Email
azadbakhtleila@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Daneshzad
Position
Ph.D. candidate in Nutriton
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 44, Hojjatdoost alley, Naderi Ave, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8895 5975
Email
daneshzad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of privacy and ethics committee, we can not distribute their information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available