Protocol summary
-
Study aim
-
Effect of Dietary Approaches to Stop Hypertension (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 groups as follows: Intervention group and the usual diet as Control group. The tendency to participate in the study, patients with type 2 diabetes and who are postmenopause and don't adhere to 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 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.
-
Settings and conduct
-
Sampling will be done in the diabetes clinic of TUMS. Characteristics information, physical activity, food records, PSQI, DASS-21 questionnaire, and blood samples will be filled before and at the end of the trial. 2groups (n=30) of participants will receive a DASH or usual diet for 12 weeks. The intervention is a diet, there is no concealing.
-
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 to 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
-
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, Advanced Glycated End Products in serum
General information
-
Reason for update
-
Sodium and potassium urine tests changed to serum vitamin C testing. Because it is not possible to store urine for 24 hours in a university laboratory. Patients also do not cooperate.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180312039055N1
Registration date:
2018-05-20, 1397/02/30
Registration timing:
prospective
Last update:
2020-04-11, 1399/01/23
Update count:
1
-
Registration date
-
2018-05-20, 1397/02/30
-
Registrant information
-
-
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)
Persons 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
Patients with depression and other psychological diseases, New events which impact on patients mood
-
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 by permuted-block randomization method . Then, individuals block according to age and body mass index (normal, overweight and obese). This study is diet therapy and doesn't have concealing processing.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-04-11, 1397/01/22
-
Ethics committee reference number
-
IR.TUMS.VCR.REC.1397.158
Health conditions studied
1
-
Description of health condition studied
-
Depression
-
ICD-10 code
-
-
ICD-10 code description
-
2
-
Description of health condition studied
-
Diabetes
-
ICD-10 code
-
-
ICD-10 code description
-
3
-
Description of health condition studied
-
sleep
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Luteinizing Hormone (LH)
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Serum levels by ELISA
2
-
Description
-
Follicle Stimulating Hormone (FSH)
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Serum levels by ELISA
3
-
Description
-
Sex Hormone Binding Globulin (SHBG)
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Serum levels by ELISA
4
-
Description
-
Testestrone
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Serum levels by ELISA
5
-
Description
-
Advanced Glycation End products (AGEs)
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Serum levels by ELISA
6
-
Description
-
depression
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
DASS-21 item questionnaire
7
-
Description
-
Sleep status
-
Timepoint
-
Before and after intervention (12wk)
-
Method of measurement
-
Pittsburgh sleep questionnaire index (PSQI)
8
-
Description
-
anxiety
-
Timepoint
-
Before and after intervention (12 wk)
-
Method of measurement
-
DASS-21 item questionnaire
9
-
Description
-
Stress
-
Timepoint
-
Before and after intervention (12 wk)
-
Method of measurement
-
DASS-21 item questionnaire
Secondary outcomes
1
-
Description
-
Weight
-
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
-
inflexible meter
3
-
Description
-
Blood pressure
-
Timepoint
-
Before and after intervention (12 wk)
-
Method of measurement
-
Digital Sphygmomanometer
4
-
Description
-
Body Mass Index (BMI)
-
Timepoint
-
Before and after intervention (12 wk)
-
Method of measurement
-
Weight in kilogram divided to square of height in meter
Intervention groups
1
-
Description
-
Intervention group: Postmenopausal diabetic patients who adhere to the DASH diet. Intervention in this group of people receiving the DASH diet as a diet rich in antioxidants for three months in which it is recommended to receive vegetables, fruits, nuts and nuts, fish, legumes and low-fat dairy products. In this diet, it is recommended to reduce the consumption of red meat, salt, and salts, as well as sweets. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying.
-
Category
-
Treatment - Other
2
-
Description
-
Control group: Postmenopausal diabetic patients who adhere usual diet. The intervention in this group of people is to receive the usual daily diet and receive the usual recommendations for three months. The amount of calories and nutrients is the same as the intervention group, but differs from the intervention group in terms of the number of food group units. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
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
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
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
Not applicable