Effect of date seed powder on glycemic markers and blood lipid profile in overweight or obese women
Design
A randomized, double-blind, placebo-controlled clinical trial. Study population: 124 overweight or obese women referred to the nutrition clinic into 2 groups receiving date seed powder supplement (400 mg per day) and control group receiving placebo (receiving 400 mg lactose-free powdered milk per day ). At first people will fill in Informed consent form ,demographic and physical activity questioners and then randomly assigned to either the intervention group and control. Both groups will receive 2 capsules daily after meals for 90 days. Height, weight, waist circumference and hip circumference will be measured at the beginning and end of the study. To measure glucose, HbA1C, insulin and the pattern of lipids and lipoproteins, 5 ml of blood will be taken before the intervention and at the end of the 90-day period. Systolic and diastolic blood pressure will be measured at the beginning and end of the study in all individuals. Used to randomize random sequence generation in exel software.
Settings and conduct
Women referring to nutrition and diet therapy clinic in Shiraz
Participants/Inclusion and exclusion criteria
Overweight or obese 20-50-year-old women with a body mass index of 25 to 40 who tend to cooperate.
Intervention groups
The intervention group received 400 mg of date seed powder (2 capsules of 200 mg) daily and the placebo group received 2 capsules daily (each capsule containing 200 mg of lactose-free milk powder). The intervention lasts for 90 days.
Effect of date seed powder on glycemic markers and lipid profile in overweight or obese women
Public title
Effect of date seed powder on blood sugar and blood lipid Index.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
20-50 years old women
Body mass index 25 to 40
Exclusion criteria:
Pregnancy and lactation
Taking lipid and blood sugar drugs
Taking Weight loss supplements and special diet
Menopause
Diabetes
Hypo or hyperthyroidism
Anemia
Gastrointestinal problems
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher selects the individuals who meet the inclusion criteria and registers their names in a list by number, and then divides the participants into intervention and placebo groups using random allocation. Random Sequence generation will be randomly assigned by a table of random numbers in Exel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants in the project assume that they have received the intervention and are unaware that they are in the date seed powder group or the placebo group. Also, the clinical researcher and data analyst is unaware of which group the participants belong to (date seed powder recipient or placebo recipient).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nutrition Faculty of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand St, Shiraz.
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1400.060
Health conditions studied
1
Description of health condition studied
obesity and lipid disorders
ICD-10 code
E65-E68
ICD-10 code description
Obesity and other hyperalimentation
Primary outcomes
1
Description
Metabolic parameters
Timepoint
Before and three months after intervention
Method of measurement
Standard laboratory kits
2
Description
Anthropometric indices
Timepoint
Before and three months after intervention
Method of measurement
Digital scales and standard meters
3
Description
Measurement of blood pressure
Timepoint
Before and three months after intervention
Method of measurement
Sphygmomanometer in millimeters of mercury
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:2 pills containing 200 mg date seed powder for 3 months
Category
Treatment - Drugs
2
Description
Control group: 2 pill containing 200 mg Lactose-free milk powder for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Nutrition and Diet Clinics
Full name of responsible person
Dr Siavash Babajafari
Street address
Central building of Shiraz University of Medical Sciences, Zand St, Shiraz.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3230 5410
Email
mary.hashemzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Sciences Reaserch Center, Shiraz University Of Medical Sciences
Full name of responsible person
Dr Siavash Babajafari
Street address
Central building of Shiraz University of Medical Sciences, Zand St, Shiraz.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3230 5410
Email
mary.hashemzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Sciences Reaserch Center, Shiraz University Of Medical Sciences
Proportion provided by this source
70
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
Maral Hashemzadeh
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Parjam building , No 8, Sattarkhan Ave, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7183743576
Phone
+98 71 3232 6788
Email
mary.hashemzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Asma Kazemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Central building of Shiraz University of Medical Sciences, Zand St, Shiraz.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3230 5410
Email
asmakazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maral Hashemzadeh
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Parjam building , No 8, Sattarkhan Ave, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7183743576
Phone
+98 71 3232 6788
Email
mary.hashemzadeh@yahoo.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
Only a section of the data, such as primary outcomes information or the like, will be shared.
When the data will become available and for how long
Access period start 6 months after results publishing
To whom data/document is available
The obtained data from current study will be available only for working researchers in academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis.
From where data/document is obtainable
Applicants can be communicated to correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition Research Center, Shiraz university of Medical Sciences, KHalili St, Shiraz. Cell phone:00987136122283.Email address:Nutrition_rs@sums.ac.ir
What processes are involved for a request to access data/document
publishing in scientific- research journals Applicants will be given access to the obtained data from current study by sending an email to the correspond author.