We studied the effect of 2 months of oral administration of powdered fenugreek seeds on blood lipid profile.
In this study, 40 patients (20 intervention and 20 controls) with hyperlipidemia in the clinical spectrum of not consumption of lipid-lowering drugs will randomly selected for the study.
inclution criteria :Samples older than 18 and younger than 65 years old were associated with fat; LDL between 160 and 189 in healthy individuals or patient with one risk factors; LDL between 130 and 159 for those with two or more risk factors.
exclution criteria:
having an underlying disease such as diabetes, IHD, hypertension, metabolic syndrome, peripheral vascular disease, coronary artery disease and ... ; LDL more than 190 that patients need medical treatment (for healthy people or individuals with one risk factor); LDL ≥ 160 in patient that need drug treatment (for those with two or more risk factors).
in intervention Group each patient receive 5 grams of powdered fenugreek seeds daily for two months, with recommendations for lifestyle changes and a control group receiving only recommendations. After two months blood examining for all of the patients is compared to the prior.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111815452N1
Registration date:2014-01-19, 1392/10/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-19, 1392/10/29
Registrant information
Name
Elahe Yousefi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 6306
Email address
elahehyousefi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dietary Fenugreek seed powder on serum lipid profiles in patients with hyperlipidemia.
Public title
TF effects on blood lipids
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria:
up to 18 years and less than 65 years old; an experiment with one of the following factors related to lipid
LDL> 135 mg / dl; HDL <40 mg / dl; Chol> 200 mg / dl; TG> 150 mg / dl.
The exclusion criteria
having underlying diseases such as diabetes, IHD, hypertension, metabolic syndrome, peripheral vascular disease, coronary artery disease and ...; LDL more than 190 in patients that need of medical treatment (for healthy people or with one risk factor); LDL ≥ 160 in patient that need drug treatment (for those with two or more risk factors).
Risk Factors: 1 - Smoking 2 - hypertension 3 - low HDL level (less than 40) 4 - history of coronary artery disease at an early age in the household (less than 55 years in males and in females under age 65years old) 5 - Age above 65 years. important point: diabetes mellitus, peripheral vascular disease and coronary artery disease are considered equivalent whit CAD. (CAD equivalent)
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Qazvin University of Medical Science
Street address
above the Dadgostary junction, Qazvin University of Medical Science
City
Qazvin
Postal code
Approval date
2013-07-15, 1392/04/24
Ethics committee reference number
5959/20/د
Health conditions studied
1
Description of health condition studied
Hyperlipidaemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
serum lipid
Timepoint
in the begining of study and then after 2 month from the begining
Method of measurement
blood exam mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
in intevention Group each patient receive 5 grams of powdered fenugreek seeds daily for two months, with recommendations for lifestyle changes along this period.
Category
Treatment - Drugs
2
Description
control Group only receive recommendations for lifestyle changes for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Katayon Ziari
Street address
Basij Highway, Besat Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mehdi Emamjoome
Street address
above Dadgostary junction, Qazvin University of Medical Science
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Science
Full name of responsible person
Elahe Yousefi
Position
Graduated student of Nutrion and Health Science
Other areas of specialty/work
Street address
No 46, Ashna ally, Tohid street
City
Qazvin
Postal code
3415747957
Phone
+98 28 1336 6306
Fax
Email
elahehyousefi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Science
Full name of responsible person
Saeid Zareiy
Position
Doctor of Medicine
Other areas of specialty/work
Street address
Tehran-Basij Highway-Besat Hospital
City
Tehran
Postal code
Phone
+98 21 3995 4956
Fax
+98 21 3995 4960
Email
zareiys@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Elaheh Yousefi
Position
Graduate student of Nutrition and Health science
Other areas of specialty/work
Street address
no 46,Ashna ally, Tohid street
City
Qazvin
Postal code
34156-47957
Phone
+98 28 1336 6306
Fax
Email
elahehyousefi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)