Investigating The effect of ginger consumption on depression, anxiety, sleep quality, cognitive function and metabolic, inflammatory and oxidative stress indices in depressed patients with overweight and obese
Determining the effect of ginger supplementation on depression and anxiety scores, sleep quality, cognitive function, and serum sugar, lipid, and inflammatory and oxidant factors in adults with depression, overweight and obesity
Design
Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 0 on 80 patients. A stratified method was used for randomization.
Settings and conduct
The selection of patients was done using simple samples available from comprehensive health service centers and psychological clinics in the city. Blinding has been done and explanations have been given in other parts, and adding information here is repetitive
Participants/Inclusion and exclusion criteria
Suffering from depression and overweight and obesity
Intervention groups
Intervention group: daily intake of 3 ginger tablets of 500 grams
Control group: daily receiving 3 placebo tablets with the same aroma, color and taste
Investigating The effect of ginger consumption on depression, anxiety, sleep quality, cognitive function and metabolic, inflammatory and oxidative stress indices in depressed patients with overweight and obese
Public title
Investigating the effect of ginger consumption on depressed patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from depression confirmed by a psychiatrist or psychologist based on the DSM-5 diagnostic criteria
Suffering from overweight and obesity or, in fact, a BMI greater than or equal to 25
No routine consumption of ginger before or during the study
Exclusion criteria:
Menopause
Pregnancy and breastfeeding
Having an unstable or severe medical condition
Follow a special diet
Taking antioxidant or anti-inflammatory supplements during the last 3 months
Having a serious mental disorder at the same time other than depression such as schizophrenia
Allergy to ginger or its products
Age
From 18 years old to 50 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
stratified permuted block randomization (allocation ratio=1:1 , block size: 4 , stratification according to Severity of depression )
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants: Both the intervention and control groups take standardized drugs
Researcher: She does not know which participant is taking the original drug and which is the placebo, and they are chosen randomly
Laboratory and statistical analysis personnel: They do not know which group each sample belongs to
Placebo
Used
Assignment
Other
Other design features
First, 80 patients were selected and then they were divided into 2 intervention and control groups based on the severity of depression by stratified random allocation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand ST
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.SUMS.REC.1403.117
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
depression
Timepoint
the beginning of the study, the end of the first month and the end of the study (the end of the second month)
Method of measurement
Beck Depression Inventory-II (BDI-II)
2
Description
Anxiety
Timepoint
the beginning of the study, the end of the first month and the end of the study (the end of the second month)
Method of measurement
Beck Anxiety Inventory
3
Description
sleep quality
Timepoint
the beginning of the study and the end of the study (the end of the second month)
Method of measurement
Pittsburgh Sleep Quality Index
4
Description
Serum TNF-a, TOS and MDA indices
Timepoint
the beginning of the study and the end of the study (the end of the second month)
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 ginger supplements daily with a dose of 500 mg for 2 months
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
All comprehensive health service centers
Full name of responsible person
Dr. Abbas Rezaianzadeh
Street address
zand blvd
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr akhlaghi
Street address
Razi blvd
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
kalanmantaghe@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh akhlaghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi blvd
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr akhlaghi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra moaddeli
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
zpmoaddeli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available upon reasonable request from Prof. Masoumeh akhlaghi
When the data will become available and for how long
12 months after the publication of the results
To whom data/document is available
Academic users
Under which criteria data/document could be used
Academic goals
From where data/document is obtainable
msm.akhlaghi@gmail.com
What processes are involved for a request to access data/document
After receiving the request, the data will be sent as soon as possible