Determination of mean lipid profile, hs-CRP inflammatory marker, fasting blood sugar, blood pressure and body mass index in hypercholesterolemia patients receiving hydrolyzed fenugreek protein and placebo
Design
A controlled clinical trial with parallel groups, double-blind, randomized, phase 3 on 60 patients, using free online random allocation software for randomization.
Settings and conduct
This study will be performed in Isfahan Chamran hospital. Sixty hypercholesterolemia patients will be selected based on inclusion and exclusion criteria and will be divided into two groups of 30 intervention and placebo. Patients will take medication 40 mg daily for 2 months. Patients will be advised to change their lifestyle. At the beginning and end of study, lipid profile, hs-CRP inflammatory marker, fasting blood sugar, blood pressure and body mass index will be measured and compared. Participants and evaluators will be blind to the outcome. The appearance of the both types of capsules will be similar and only the researcher will know about the assignment of patients to groups.
Intervention group: fenugreek hydrolyzed protein. Control group: similar capsule filled by placebo.
Main outcome variables
Lipid profile؛ hs-CRP inflammatory marker؛ fasting blood sugar؛ blood pressure؛ body mass index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210125050142N1
Registration date:2021-03-11, 1399/12/21
Registration timing:prospective
Last update:2021-03-11, 1399/12/21
Update count:0
Registration date
2021-03-11, 1399/12/21
Registrant information
Name
Mahdi Badiee Gavarti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3577 0701
Email address
mbadieeg@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of the fenugreek hydrolyzed protein on lipids and CRP levels in hypercholesterolemia patients
Public title
Evaluation the effect of fenugreek on reducing blood lipids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with low to moderate risk for cardiovascular events
LDL 116 -180 mg /dL
Exclusion criteria:
Drinking alcohol,
Use of effective supplements on blood lipids (such as fish oil), Immunosuppressive drugs, blood lipid-lowering drugs (statins, fibrates, niacin, …)
People with hypothyroidism, nephrotic syndrome or renal dysfunction or liver dysfunction
People with uncontrolled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 mmHg),
History of dizziness and convulsions,
Pregnancy or lactation
Sensitivity to studied plant
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, it determines a total sample size, then randomly assigns a set of them to groups A and group B, which is executed by random allocation software, which produces a sequence of random numbers with the intended code. The output list of random numbers is printed. Then, based on the sample size of the research, a number of envelopes are prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, one of the envelopes of the letter is opened and the assigned group of the participant is revealed according to the order of entry of the eligible participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. Both participants and outcome assessors are unaware of the type of intervention received, but patients will be explained how to implement the plan and whether they are randomly assigned to one of these two groups. The size, color and design of the drug under study and the placebo prescribed in the two groups are quite similar. The lead researcher determines the drug codes and the participants and evaluators of the project are not aware of the type of drugs received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of the National Institute for medical research development
Street address
No. 21, beginning of Besat St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.NIMAD.REC.1398.402
Health conditions studied
1
Description of health condition studied
Hypercholesterolemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean of Total Cholesterol
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
2
Description
Mean of High-Density Lipoprotein
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
3
Description
Mean of Low-Density Lipoprotein
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
4
Description
Mean of Triglyceride
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
5
Description
Mean of high-sensitivity C-reactive protein
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
Secondary outcomes
1
Description
Mean of fasting blood sugar
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood level mg mg / dL by laboratory
2
Description
Mean of blood pressure
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Blood pressure monitor
3
Description
Mean of body mass index
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Tape meters, digital scales and calculation formulas
Intervention groups
1
Description
Intervention group: Patients in this group will be prescribed a 40 gram capsule of fenugreek hydrolyzed protein daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient taking the prescribed drug.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will be prescribed a 40-gram placebo capsule, which is similar in appearance and packaging to the main drug under study, daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient is taking the prescribed drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Masoumeh Sadeghi
Street address
2nd Moshtagh St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81661 73414
Phone
+98 31 3260 0961
Email
heart@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National institute for medical research development
Full name of responsible person
Reza malekzadeh
Street address
No. 21, Besat St., beginning of West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National institute for medical research development
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Badiee Gavarti
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3577 0701
Email
badiee9675@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoumeh Sadeghi
Position
Research Professor of Cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Rahmani Alley., Salman-e-Farsi, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
81661 73414
Phone
+98 31 3611 5310
Email
sadeghimasoumeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Badiee Gavarti
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3577 0701
Email
badiee9675@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available