In this study،patients were referred to an endocrinologist with Objective of Determination the Effects of fenugreek seeds consumption on metabolic status,serum adiponectin،Hs-CRP & ICAM-1(Intercellular Adhesion Molecule-1) levels in type2 diabetic patients and regard to inclusion criteria :at least 6 months history of diabetes ؛ use of blood sugar lowering drugs؛BMI ≤ 35, women 30-50 years and men age 30-60 and Exclusion Criteria: Pregnancy and lactation ؛ liver disease،kidney، heart disease،thyroid disease،inflammatory and ... ؛Patients treated with insulin،lipid lowering drugs، diuretics،and use of dietary supplements،vitamins and minerals ؛ hormone therapy ؛ smoking؛ change in dose of oral hypoglycemic drugs during the study ؛ taking antioxidant supplements at least three months before the study and during the study؛ at least 6 weeks prior to the intervention diet weight loss،Will be studied . 45 subjects were randomly divided into two groups (taking Fenugreek) and control (placebo) will be divided. Groups for 8 weeks, 10 grams of powdered Fenugreek and control 5 grams of starch in turn receive. Compounds every 2 weeks people will be delivered and to measure compliance with them at each visit، envelopes The case will be reviewed. complete inventory and assessment of general characteristics، anthropometric measurements (height and weight to calculate BMI) for each patient was performed to assess food intake questionnaire،reminder 24 hours for 3 days a week (2 days and 1 holiday) at baseline، end of week 4 and 8 of the study will be completed. individuals will be trained by the end of the study taking any supplements،not changing routine diet and exercise،report every changes . even if you do not wish to be notified and will have the right to withdraw from the study. From each of 10 ml blood sample after a 12-14 hour fast at the beginning and end of the intervention will be considered before taking hypoglycemic agents. Measurement of fasting blood glucose levels, HbA1c, fasting serum insulin, insulin resistance, serum lipids, adiponectin, Hs-CRP and ICAM-1 in both groups before and after the intervention will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301263664N9
Registration date:2013-03-16, 1391/12/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Reseach Center of Tabriz University of Medical Sciences, Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of fenugreek seeds consumption on metabolic status,serum adiponectin,Hs-CRP & ICAM-1(Intercellular Adhesion Molecule-1) levels in type2 diabetic patients
Public title
Effects of fenugreek seeds consumption on metabolic status,serum adiponectin,Hs-CRP & ICAM-1(Intercellular Adhesion Molecule-1) levels in type2 diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Volunteered to Participate in The Sudy ؛At Least 6 Months History of Dabetes ؛Use of Blood Sugar Lowering Drugs؛BMI ≤ 35, Women 30-50 Years and Men Age 30-60، Exclusion Criteria: Pregnancy and lactation ؛Liver Disease،Kidney،Heart Disease،Thyroid Disease،Inflammatory and ... ؛Patients treated with Insulin،Lipid Lowering Drugs، Diuretics،and Use of Detary Supplements،Vitamins and Minerals ؛Hormone Therapy ؛Smoking؛Change in Dose of Oral Hypoglycemic Drugs During The Study ؛Taking Antioxidant Supplements at Least Three Months before the Study and During The Study؛ at Least 6 Weeks Prior to The Intervention Diet Weight Loss
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Attar Neishaboori Avenue, Golgasht Atreet
City
Tabriz
Postal code
Approval date
2013-03-02, 1391/12/12
Ethics committee reference number
11673/4/5
Health conditions studied
1
Description of health condition studied
Diabet Mellitus
ICD-10 code
E11
ICD-10 code description
Non-Insulin-Dependent Diabetes Mellitus
Primary outcomes
1
Description
FBS
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
2
Description
HbA1C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With HPLC
3
Description
Level of Serum Insulin
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
4
Description
HOMA-IR
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Calculated According to The Formula
5
Description
Total Cholestrol
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
6
Description
LDL-C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Calculated According to The Friedwald Formula
7
Description
HDL-C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Immunoturbidimetry
8
Description
TG
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
9
Description
Level of Serum Adiponectin
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
10
Description
Level of Serum Hs-CRP
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Immunoturbidimetry
11
Description
Level of Serum ICAM-1
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
Secondary outcomes
empty
Intervention groups
1
Description
10 G of Powdered Fenugreek Seeds Twice a Day - 8 Weeks
Category
Treatment - Other
2
Description
5 G Starch Twice a Day- 8 Weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology clinic of Tabriz Sina Hospital
Full name of responsible person
Mina Malekiyan
Street address
Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Reseach Center of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Reseach Center of Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Reza Rashidy
Street address
Tabriz University of Medical Sciences, Daneshgah Street
City
Tabriz
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, Tabriz University of Medical Sciences
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Mina Malekiyan
Position
MS Sudent in Nutrition
Other areas of specialty/work
Street address
Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 42 6223 0227
Fax
Email
mina.malekiyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mina Malekiyan
Position
MS Student in Nutrition
Other areas of specialty/work
Street address
Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 42 6223 0227
Fax
Email
mina.malekiyan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mina Malekiyan
Position
MS Student in Nutrition
Other areas of specialty/work
Street address
Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)