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Effect of fenugreek seed on anthropometric indicators, blood pressure, liver and kidney function, depression and anxiety in type 2 diabetic patients

Protocol summary

Summary
Study aim: determination of the Effect of fenugreek seeds on anthropometric indicators, blood pressure, liver and kidney function, depression and anxiety in type 2 diabetic patients. Study design: Randomized, controlled, no blinding, no placebo, single-center, parallel. Study population: Inclusion criteria: type 2 diabetes; 30-65 years old; at least 1 year and up to 10 year diabetic history; Body Mass Index<35 . Exclusion criteria: insulin therapy; menopause or hysterectomy for women; having any certain diseases or using any certain medications other than diabetic ones; allergy to Fabaceae family herbs; using dietary supplements and other medicinal plants for at least three months prior to the study; smoking or using drugs. Sample size: 48 persons. Random assignment method: Binary random block method. 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. Control group: routine diabetic drugs. Duration of intervention: 8 weeks. Study outcomes: Waist circumference, Hip circumference, Lipid accumulation product index, Blood pressure, Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase, Blood urea nitrogen, Creatinine, estimated Glomerular filtration rate, Depression and Anxiety.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072732294N3
Registration date: 2017-08-21, 1396/05/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Rahele Tavakoly
Name of organization / entity
Isfahan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8487
Email address
rahele.tavakoli@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fenugreek seed on anthropometric indicators, blood pressure, liver and kidney function, depression and anxiety in type 2 diabetic patients
Public title
Effect of Fenugreek on the Treatment of Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetes; 30-65 years old; at least 1 year and up to 10 year diabetic history; Body Mass Index<35 Exclusion criteria: insulin therapy; menopause or hysterectomy for women; having any certain diseases or using any certain medications other than diabetic ones; allergy to Fabaceae family herbs; using dietary supplements and other medicinal plants for at least three months prior to the study; smoking or using drugs
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: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jirib st.
City
Isfahan
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.MUI.REC.1395.3.225

Health conditions studied

1

Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11.9
ICD-10 code description
Non-insulin-dependent 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
Blood urea nitrogen
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits

8

Description
Creatinine
Timepoint
baseline and 8 weeks after intervention
Method of measurement
blood sampling and commercial kits

9

Description
depression
Timepoint
baseline and 8 weeks after intervention
Method of measurement
"Hospital Anxiety and Depression Scale" questionnaire

10

Description
anxiety
Timepoint
baseline and 8 weeks after intervention
Method of measurement
"Hospital Anxiety and Depression Scale" questionnaire

Secondary outcomes

1

Description
Lipid accumulation product index
Timepoint
baseline and 8 weeks after intervention
Method of measurement
Formula calculation

2

Description
estimated glomerular filtration rate
Timepoint
baseline and 8 weeks after intervention
Method of measurement
Formula calculation

Intervention groups

1

Description
intervention: 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: routine diabetic drugs for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Aminorroaya Yamini
Street address
Khorram Street, Jomhouri Square
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezar Jirib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahele tavakoly
Position
PhD. candidate of nutrition sciences
Other areas of specialty/work
Street address
Hezar Jirib st.
City
Isfahan
Postal code
Phone
+98 31 3792 3151
Fax
Email
tavakkoli.rahele@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahele Tavakoly
Position
PhD. candidate of nutrition sciences
Other areas of specialty/work
Street address
Hezar Jirib st.
City
Isfahan
Postal code
Phone
+98 31 3792 3151
Fax
Email
tavakkoli.rahele@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahele tavakoly
Position
PhD. candidate of nutrition sciences
Other areas of specialty/work
Street address
Hezar Jirib st.
City
Isfahan
Postal code
Phone
+98 31 3792 3151
Fax
Email
tavakkoli.rahele@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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