The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients
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Protocol summary
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.
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 with 21 paticipants 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.
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 with 21 paticipants 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.
این مطالعه به صورت کارآزمایی بالینی سه سوکور با هدف تعیین اثر مکمل یاری پودر هسته خرما بر روی بیماران مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 20 نفره مداخله و کنترل با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد از هماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد.
این مطالعه به صورت کارآزمایی بالینی سه سوکور با هدف تعیین اثر مکمل یاری پودر هسته خرما بر روی بیماران مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 21 نفره مداخله و کنترل با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد از هماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد.
این مطالعه به صورت کارآزمایی بالینی سه سوکور با هدف تعیین اثر مکمل یاری پودر هسته خرما بر روی بیماران مبتلا به دیابت نوع 2، انجام خواهد پذیرفت. بیماران بطور تصادفی به دو گروه 2021 نفره مداخله و کنترل با استفاده از نرم افزار RAS و در قالب بلوک های 6 نفری بعد از هماهنگ سازی از لحاظ سن و نمایه توده بدنی تقسیم خواهند شد.
General information
40
42
4042
2022-01-21, 1400/11/01
2022-04-09, 1401/01/20
2022-0104-2109 00:00:00
2022-03-21, 1401/01/01
2022-09-21, 1401/06/30
2022-0309-21 00:00:00
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No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
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تغییراتی در پروتکل مطالعه حاضر انجام نیافته است وفقط برخی پارامترها اضافه شده اند. بر طبق مرور بر متون جامع محققین، کلیه پارامترهای اضافه شده همراه با پارامترهای ثبت شده به صورت یک طرح جامع ارایه گردیده بود. اما قبل از ثبت این طرح در مرکز کارآزمایی های بالینی بواسطه محدودیت مالی، پاره ای از پارامترهای مورد مطالعه حذف گردیده بود. اخیرا بواسطه تامین مالی طرح در قالب گرنت پژوهشی محققین برتر، محققین پارامترهای محذوف را مجددا به طرح اضافه نموده اند تا یک مطالعه جامع در این زمینه صورت پذیرد.
تغییراتی در پروتکل مطالعه حاضر انجام نیافته است وفقط برخی پارامترها اضافه شده اند. بر طبق مرور بر متون جامع محققین، کلیه پارامترهای اضافه شده همراه با پارامترهای ثبت شده به صورت یک طرح جامع ارایه گردیده بود. اما قبل از ثبت این طرح در مرکز کارآزمایی های بالینی بواسطه محدودیت مالی، پاره ای از پارامترهای مورد مطالعه حذف گردیده بود. اخیرا بواسطه تامین مالی طرح در قالب گرنت پژوهشی محققین برتر، محققین پارامترهای محذوف را مجددا به طرح اضافه نموده اند تا یک مطالعه جامع در این زمینه صورت پذیرد.
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.
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=21, receiving date seed powder) control (n=21, receiving Maltodextrin) using RAS software into 2 and 4 blocks, and will be given codes 1 and 2.
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=2021, receiving date seed powder) control (n=2021, receiving Maltodextrin) using RAS software into 2 and 4 blocks, and will be given codes 1 and 2.
در ابتدای مطالعه، افراد واجد شرایط از لحاظ متغیرهای BMI و سن با روش طبقه بندی این متغیرها همسان سازی خواهند شد.افراد بطور تصادفی به دو گروه 20 نفره مداخله (دریافت کننده پودر هسته خرما ) کنترل (دریافت کننده مالتودکسترین) با استفاده از نرم افزار RAS و در قالب بلوک های 2و 4 نفری تقسیم و به آنها کدهای 1و 2 داده خواهد شد.
در ابتدای مطالعه، افراد واجد شرایط از لحاظ متغیرهای BMI و سن با روش طبقه بندی این متغیرها همسان سازی خواهند شد.افراد بطور تصادفی به دو گروه 21 نفره مداخله (دریافت کننده پودر هسته خرما ) کنترل (دریافت کننده مالتودکسترین) با استفاده از نرم افزار RAS و در قالب بلوک های 2و 4 نفری تقسیم و به آنها کدهای 1و 2 داده خواهد شد.
در ابتدای مطالعه، افراد واجد شرایط از لحاظ متغیرهای BMI و سن با روش طبقه بندی این متغیرها همسان سازی خواهند شد.افراد بطور تصادفی به دو گروه 2021 نفره مداخله (دریافت کننده پودر هسته خرما ) کنترل (دریافت کننده مالتودکسترین) با استفاده از نرم افزار RAS و در قالب بلوک های 2و 4 نفری تقسیم و به آنها کدهای 1و 2 داده خواهد شد.
Primary outcomes
#1
At baseline and three two after baseline
At baseline and and two months after the start of the study
At baseline and threeand two months after baselinethe start of the study
KIT
Kit
KITKit
#2
At baseline and three two after baseline
At baseline and two months after start of the study
At baseline and three two months after baselinestart of the study
كيت اختصاصي
كيت
كيت اختصاصي
#3
At baseline and three two after baseline
At baseline and two months after start of the study
At baseline and three two months after baselinestart of the study
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 with 21 paticipants 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.
No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
Acronym
IRCT registration information
IRCT registration number:IRCT20150205020965N10
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2022-06-25, 1401/04/04
Update count:1
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
dehghanp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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:
42
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=21, receiving date seed powder) control (n=21, 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.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-10-16, 1399/07/25
Ethics committee reference number
IR.TBZMED.REC.1400.752
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Lipid profile (TG, TC, HDL-c)
Timepoint
At baseline and and two months after the start of the study
Method of measurement
Kit
2
Description
Total antioxidant capacity
Timepoint
At baseline and two months after start of the study
Method of measurement
Kit
3
Description
Malondialdehyde
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
4
Description
Tumor Necrosis Factor(TNF)
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
5
Description
Highly sensitive C-reactive protein(hs-CRP )
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
6
Description
HbA1c
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
7
Description
Fasting glucose
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
8
Description
Fasting insulin
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
9
Description
Interleukins 4, 6, 10, 18
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
10
Description
fructosamine
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
11
Description
LPS endotoxin
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
12
Description
Pentosidine
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
13
Description
Total oxidant status (TOS)
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
14
Description
carboxymethyl lysine (CML)
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
15
Description
soluble receptor for advanced glycation end-products
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
16
Description
8-iso-prostaglandin F2α
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
17
Description
brain-derived neurotrophic factor
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
18
Description
cortisol
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
19
Description
Tryptophan
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
20
Description
Kynurenine
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
21
Description
Adrenocorticotropic hormone
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
22
Description
Adipokines (leptin and adiponectin)
Timepoint
At baseline and two months after start of the study
Method of measurement
enzyme-linked immunosorbent assay (ELISA) kit
23
Description
T lymphocyte ( CD4 and CD8)
Timepoint
At baseline and two months after start of the study
Method of measurement
flow cytometry
24
Description
Glutathione peroxidase
Timepoint
At baseline and two months after start of the study
Method of measurement
Kit
25
Description
Superoxide dismutase
Timepoint
At baseline and two months after start of the study
Method of measurement
Kit
26
Description
Catalase
Timepoint
At baseline and two months after start of the study
Method of measurement
Kit
27
Description
Uric acid
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
28
Description
8-Hydroxy-2-deoxy-guanosine
Timepoint
At baseline and two months after start of the study
Method of measurement
kit
Secondary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
At baseline and two months after baseline
Method of measurement
Scale-Meter
2
Description
Energy intake, Daily macronutrient intake (carbohydrate, protein, fat)
Timepoint
At baseline and two months after baseline
Method of measurement
questionnaire
3
Description
General Health , Sleep quality, Depression, Anxiety and Stress
Timepoint
At baseline and two months after baseline
Method of measurement
questionnaire
4
Description
Blood pressure
Timepoint
At baseline and two months after baseline
Method of measurement
manometer
Intervention groups
1
Description
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.