to examine the effects of fenugreek seeds on anthropometric indexes, some blood factors, depression, and anxiety in type 2 diabetic patients.
Design
parallel, randomized, controlled trial
Settings and conduct
setting: university clinics
Fasting blood samples were drawn at baseline and end of the study to measure blood factors
Participants/Inclusion and exclusion criteria
type 2 diabetes; 30-65 years old; up to 10 year diabetic history; Body Mass Index<35; no insulin therapy; no menopause or hysterectomy (women); not having any certain diseases or not using any certain medications other than diabetic ones; not having allergy to Fabaceae family herbs; not using dietary supplements and other medicinal plants for at least three months prior to the study
Intervention groups
intervention group: 15 grams of powdered fenugreek seeds in doses of 5 grams three times a day between meals, dissolved in water, besides routine treatments, for 8 weeks
control group: routine treatments
Effect of fenugreek seed on anthropometric indicators, some blood factors, depression, and anxiety in type 2 diabetic patients
Public title
Effect of fenugreek seed on the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
type 2 diabetes
30-65 years old
up to 10 year diabetic history
Body Mass Index<35
Exclusion criteria:
insulin therapy
menopause or hysterectomy (women)
having any certain diseases or using any certain medications other than diabetic ones
having allergy to Fabaceae family herbs
using dietary supplements and other medicinal plants for at least three months prior to the study
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
binary random block method
Unit of randomization: individual
Randomization strata: age, sex, body mass index
Tools used in randomization: coin
The allocation was concealed from the clinical recruitment staff until each patient had entered the trial and received a randomization code
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman university of medical sciences
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.KMU.REC.1398.188
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Hip circumference
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measuring tape
2
Description
waist circumference
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measuring tape
3
Description
blood pressure
Timepoint
baseline and 8 weeks after intervention
Method of measurement
sphygmomanometer
4
Description
Alanine Amino Transferase
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
5
Description
Aspartate aminotransferase
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
6
Description
Alkaline phosphatase
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
7
Description
depression and anxiety
Timepoint
baseline and 8 weeks after intervention
Method of measurement
"Hospital Anxiety and Depression Scale" questionnaire
8
Description
irisin
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
9
Description
triglyceride
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
10
Description
Low-density lipoprotein
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
11
Description
high-density lipoprotein
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
12
Description
fasting plasma glucose
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
13
Description
2-h post prandial glucose
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
14
Description
insulin
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
15
Description
HbA1C
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
16
Description
Blood urea nitrogen
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
17
Description
Creatinine
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 grams of powdered fenugreek seeds in doses of 5 grams three times a day between meals, dissolved in water, besides routine diabetic drugs, for 8 weeks
Category
Treatment - Other
2
Description
Control group: routine diabetic drugs for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University Clinics
Full name of responsible person
Morteza Hashemian
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5086
Email
tavakkoli.rahele@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Davood Kalantar
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5086
Email
tavakkoli.rahele@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Rahele Tavakoly
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5086
Email
tavakkoli.rahele@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rahele Tavakoly
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5086
Email
tavakkoli.rahele@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rahele Tavakoly
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Haft Bagh-E-Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5086
Email
tavakkoli.rahele@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 the data from the original outcomes can be shared
When the data will become available and for how long
the results will become available after publication
To whom data/document is available
some additional supporting information can be shared for anyone in academic institutions who applies
Under which criteria data/document could be used
using additional supporting information is just for receiving more details about the study and should not be used anywhere without the permission of the researchers
From where data/document is obtainable
for additional supporting information, you can email Dr. Rahele Tavakoly (tavakkoli.rahele@yahoo.com)
What processes are involved for a request to access data/document
1. Request letter
2. The reasons for the request and the type of uses of the additional supporting information
3. Applicant'sacademic profile and applicant's organization's name
4. An official contract with a signed and authentic signature from the applicant's organization that the use of the information is under the consent of the researchers.