Protocol summary

Study aim
Determining the effect of fenugreek seed extract supplement on serum levels of FBS, serum insulin and IR and serum levels of TG, HDL, LDL, TC and the amount of appetite and energy and macronutrient intake and the amount of oxidant and antioxidant balance (PAB) in individuals With T2DM
Design
This study is a randomized double-blind parallel clinical trial using the block Randomization method in which patients with type 2 diabetes will be divided into two subgroups of 23 complementary and placebo.
Settings and conduct
Patients with type 2 diabetes will be divided into two subgroups of 23 complementary and placebo using the Block Randomization method. Other than the researcher, they are coded as A and B. Patients will receive fenugreek seed extract in the form of three 335 mg tablets and the control group will receive three 335 mg placebo tablets daily for 8 weeks. Finally, the serum of the participants will be measured in terms of lipid parameters, fasting blood sugar, serum insulin and PAB.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-Patients in the age range of 30-65 years 2-Having at least 6 months of diabetes history (according to criteria of American Diabetes Association) 3-BMI between 25 and 35 4-Taking blood sugar lowering drugs 5-Willingness to participate in the project Exclusion criteria: 1-Pregnancy or breastfeeding or its intention 2-Kidney, liver, gastrointestinal, thyroid, and rheumatic diseases
Intervention groups
Individuals in the supplement group will receive three 335 mg fenugreek seed extract tablets daily and the control group will receive three 335 mg placebo tablets daily.
Main outcome variables
Fasting blood sugar, lipid profile (HDL, LDL, TG, TC), PAB (oxidant and antioxidant balance)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210407050881N1
Registration date: 2022-01-04, 1400/10/14
Registration timing: retrospective

Last update: 2022-01-04, 1400/10/14
Update count: 0
Registration date
2022-01-04, 1400/10/14
Registrant information
Name
Fatemeh Chehregosha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3762 4300
Email address
fatemehchehregosha4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fenugreek Seed Extract Supplementation on Blood glucose,Lipid profile, Appetite, Energy Intake and Macronutrient, Oxidative stress in Patients with Type 2 Diabetes:Randomized Double-blind Controlled clinical Trial
Public title
Effect of fenugreek seed extract on oxidative stress in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 30-65 years Having at least 6 months of diabetes history (according to criteria of American Diabetes Association) BMI between 25 and 35 Taking blood sugar lowering drugs No herbs at least 3 months before the study to be used routinely Willingness to participate in the project
Exclusion criteria:
Pregnancy or breastfeeding or its intention Kidney, liver, gastrointestinal, thyroid, and rheumatic diseases Allergy to plants of the Fabaceae family
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects using RAS software (Random allocation software) and randomly, using the method of random blocking (block randomization) in terms of classification on body mass index (25-30 or 35-30 kg / m2) And gender (female or male) and inclusion in the study in the form of 4 groups and blocks with size of 6 , are divided into 2 groups of 23 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
For double-blind research, at the beginning of the study, a set of cans containing the corresponding capsule, which are similar in appearance (color, odor, size, shape), are coded A and B by someone other than the researcher until the researcher is informed. And patients of the type of capsules received by each group.The drug and placebo were similar in characteristics and appearance (color, odor, size)
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Factulty of Nutrition, Tabriz University of Medical Sciences, Golgasht St, Attar Neyshabouri St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.242

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Fasting blood suger
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of blood levels using electrochemical methods

2

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

3

Description
insulin resistance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Formula calculation

4

Description
Triglyceride
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level using spectrophotometric method

5

Description
LDL
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Friedwald Computational Method

6

Description
HDL
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level using spectrophotometric method

7

Description
total cholestrol
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level using spectrophotometric method

8

Description
PAB
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level by ELISA kit

9

Description
Appetite
Timepoint
Before intervention and 2 months after intervention
Method of measurement
questionnaire

10

Description
Calorie intake
Timepoint
Before intervention and 2 months after intervention
Method of measurement
questionnaire(Finally, energy calculation using n4 software)

11

Description
macronutrients intake
Timepoint
Before intervention and 2 months after intervention
Method of measurement
n4 software

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dry extract of fenugreek seeds of Barij Essential Oil Company called "Glucorx B" (containing 46.4 micrograms of luteolin per tablet) will be consumed in the form of three 335 mg tablets. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations.
Category
Treatment - Drugs

2

Description
Control group: will consume three 335 mg placebo tablets made of microcrystalline cellulose prepared by Barij Essential Oil Company. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Laboratory, Faculty of Nutrition, University of Medical Sciences
Full name of responsible person
Zhila Sadeghi
Street address
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
nutritionfaculty@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat Esfanjani
Street address
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
info@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Chehregosha
Position
Master of sience in clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
fatemehchehregosha4@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Chehregosha
Position
Master of sience in clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
fatemehchehregosha4@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Chehregosha
Position
Master of sience in clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
fatemehchehregosha4@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
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