The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients
Determining The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients
Design
This Randomized, three-blind study to determine the effects of date seed powder supplementation on patients with type 2 diabetes will be done. Patients were randomly divided into two groups based on a block randomization procedure of size six by using random allocation software (RAS). Each block involves patients with the same categories of BMI and age.
Settings and conduct
This randomized, three- blind clinical trial will be performed on T2DM patients from the Iran Diabetes Society and Hospitals of Kerman University of Medical Science.
Participants/Inclusion and exclusion criteria
Inclusion criteria included having at least 6 months of history of diabetes, age range 30 to 50 years, BMI between 25 to 30 and no weight changes during the last 3 months, no insulin therapy and use of antihypertensive drugs, propensity to take Date seed powder during the study and exclusion criteria include the use of insulin therapy, specific medications, receiving antioxidant supplements at least three months before the start of the study, a history of weight loss diet during the last 6 months or special diet, the presence of disease or Impairment, alcohol or smoking, pregnancy, lactation, being an athlete, strenuous physical activity and unwillingness to consume palm seed powder and gastrointestinal symptoms during the study.
Intervention groups
The intervention group will receive 5 grams of date seed powder daily for 8 weeks.
The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients
Public title
The effect of date seed powder on diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 6 months of diabetes history
No weight changes during the last 3 months
No insulin therapy
Use of blood sugar lowering drugs
Tendency to consume palm kernel powder during the study
Having a BMI between 25 and 35
Exclusion criteria:
Use of glucocorticoids, laxatives, anti-obesity, multivitamins, nonsteroidal anti-inflammatory drugs (NSAIDS) and antibiotics
Take antioxidant supplements at least three months before the start of the study
History of weight loss diet in the last 6 months or special diet
Having diseases such as intestinal diseases such as inflammation of the intestines, intestinal cancer and digestive problems
Having thyroid disorders, heart disease, kidney, liver, lung, infectious and other cancers treated with radiotherapy
Alcohol or smoking
Pregnancy, breastfeeding, being an athlete or doing strenuous physical activity
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At baseline, eligible individuals will be matched for BMI and age according to the classification of these variables. Individuals will be randomly divided into two groups, the intervention group (n=20, receiving date seed powder) control (n=20, receiving Maltodextrin) using RAS software into 2 and 4 blocks, and will be given codes 1 and 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After randomization, both groups will be given date seed powder and maltodextrin that encoded in sachets weighing 2.5 g in similar packages (metalized) without the researcher intervention and coded with codes 1 and 2. Until releasing of study results, the patient, the researcher, and the data analyzer will not be aware of the assigned codes. Therefore, the study will be three-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Intervention group: date seed powder. This group will consume two sachets of 2.5 g of date seed powder (Flavinea Company, Iran) daily for 2 months in the morning and evening in food such as drinks or yogurt.
Category
Treatment - Other
2
Description
Control group: maltodextrin. The group will consume two sachets of 2.5 g of maltodextrin (Qinhuangdao Lihua Starch co, china) daily for two months in the morning and evening in foods such as beverages or yogurt.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital of Kerman
Full name of responsible person
Parvin Dehghan
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
Email
dehghan.nut@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neyshabori Street, Golghash street, Nutrition Faculty, Tabriz University Of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
Email
dehghanp@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neyshabori Street, Golghash street, Nutrition Faculty, Tabriz University Of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
Email
dehghanp@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant data will be presented in the article without identifiable details
When the data will become available and for how long
2022-2023
To whom data/document is available
Tabriz University of Medical Sciences
Under which criteria data/document could be used
The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.
From where data/document is obtainable
Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.