Protocol summary

Summary
study aim: to determine the effect of fenugreek seeds on serum irisin level, glucose metabolism and lipid profile in diabetes type 2 study design: Randomized, controlled, no blinding, no placebo, single-center, parallel study Methods: A) study population: Inclusion criteria: voluntary participation; At least 1 year and a maximum of 10 years diabetes history and observing at least 6 months diabetic diet; taking oral drugs lowering blood glucose to control diabetes; 18 to 65 years old; Lack of pregnancy and lactation; Not having certain diseases (liver, kidney, heart, thyroid, rheumatoid, respiratory, metabolic, gastrointestinal, malignancy, allergic diseases); no need for insulin; not using dietary, vitamin and mineral supplements, at least three months before the study; not hormone therapy; no smoking; no using other medicinal plants routinely, at least 3 months prior to the study exclusion criteria: unwillingness to continue; developing specific diseases (liver, kidney, heart, thyroid, rheumatoid, respiratory, metabolic, gastrointestinal, malignancy, allergic diseases) during the study; starting pregnancy and lactation; starting insulin therapy; starting using dietary, vitamin and mineral supplements; change in the dose of oral blood glucose lowering drugs; Change in the physical activity during the study; start taking other medicinal plants routinely B) study intervention: 15 grams of powdered fenugreek seeds in doses of 5 grams three times a day between meals, dissolved in water C) duration of intervention: 8 weeks D)study outcomes: FBS، 2hPPG ،HbA1c ، fastin insulin، HOMA-IR ، HOMA-B و QUICKI irisin T-chol, LDL, HDL, TG, VLDL

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017013032294N1
Registration date: 2017-03-07, 1395/12/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-07, 1395/12/17
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
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of fenugreek seeds on serum irisin level, glucose metabolism and lipid profile in diabetes type 2
Public title
effect of fenugreek in the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: voluntary participation; At least 1 year and a maximum of 10 years diabetes history and observing at least 6 months diabetic diet; taking oral drugs lowering blood glucose to control diabetes; 18 to 65 years old; Lack of pregnancy and lactation; Not having certain diseases (liver, kidney, heart, thyroid, rheumatoid, respiratory, metabolic, gastrointestinal, malignancy, allergic diseases); no need for insulin; not using dietary, vitamin and mineral supplements, at least three months before the study; not hormone therapy; no smoking; no using other medicinal plants routinely, at least 3 months prior to the study exclusion criteria: unwillingness to continue; developing specific diseases (liver, kidney, heart, thyroid, rheumatoid, respiratory, metabolic, gastrointestinal, malignancy, allergic diseases) during the study; starting pregnancy and lactation; starting insulin therapy; starting using dietary, vitamin and mineral supplements; change in the dose of oral blood glucose lowering drugs; Change in the physical activity during the study; start taking other medicinal plants routinely
Age
From 18 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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
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
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HDL
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

2

Description
LDL
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

3

Description
total cholestrol
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

4

Description
triglyceride
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

5

Description
irisin
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level by ELISA kit

6

Description
fasting glucose
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

7

Description
2hppg
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level

8

Description
HbA1C
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of blood level

9

Description
insulin
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
Measurement of serum level by ELISA kit

10

Description
VLDL
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
formula calculation

Secondary outcomes

1

Description
HOMA-IR
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
formula calculation

2

Description
HOMA-B
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
formula calculation

3

Description
QUICKI
Timepoint
before intervention and 2 months after starting the intervention
Method of measurement
formula calculation

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 for 8 weeks
Category
Treatment - Other

2

Description
control group: no action
Category
Treatment - Other

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
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Entezari
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
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
School of Nutrition and Food Sciences, 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 3668 8487
Fax
Email
tavakkoli.rahele@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nutrition and Food Sciences, 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 3668 8487
Fax
Email
tavakkoli.rahele@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutrition and Food Sciences, 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 3668 8487
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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