The Effect of Fenugreek Seed Extract Supplementation on Body Composition, Blood Pressure, IL-1β, Adiponectin, and Depression in Patients with Type 2 Diabetes: Randomized Double-Blind Controlled Clinical Trial
Determining the effect of dry fenugreek seed extract on body composition, blood pressure, IL-1β, adiponectin, and depression in people with type 2 diabetes
Design
This study is a controlled parallel, and double-blind, phase 3 clinical trial, which is randomized using the Block Randomisation method.
Settings and conduct
Type 2 diabetics will be divided into the supplementation and placebo groups, each with 23 people.
For being double-blind research, at the beginning of the study, the boxes of tablets will be coded in A and B by someone other than the researcher.
Assessments including anthropometric indices, blood pressure, and depression questionnaire will be measured and completed at the beginning and end of the study for all individuals in the Nutrition Faculty of Tabriz University of Medical Sciences. Blood samples will also be collected to measure IL-1β and adiponectin.
The supplement group will receive three 335 mg fenugreek seed extract tablets daily and the control group will receive three 335 mg placebo tablets.
Participants/Inclusion and 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
Non inclusion Criteria:
-Pregnancy or breastfeeding or its intention
-Kidney, liver, gastrointestinal, thyroid, and rheumatic diseases
-Allergy to plants of the Fabaceae family
Intervention groups
The supplement group will receive three 335 mg fenugreek seed extract tablets daily and the control group will receive three 335 mg placebo tablets.
Main outcome variables
Body composition; blood pressure; IL-1β; Adiponectin; Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210407050880N1
Registration date:2021-12-25, 1400/10/04
Registration timing:retrospective
Last update:2021-12-25, 1400/10/04
Update count:0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Laleh Fakhr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 5336
Email address
lalehfakhrnut@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 Body Composition, Blood Pressure, IL-1β, Adiponectin, and Depression in Patients with Type 2 Diabetes: Randomized Double-Blind Controlled Clinical Trial
Public title
Effect of Fenugreek Seed Extract on inflammation in Patients with Type 2 Diabetes
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 are randomly divided into two groups of 23 people, by application of RAS software (Random allocation software) and using block randomization method according to the classification on body mass index (30-25 or 35-30 kg/m2) and gender (male or female), and in the form of 4 groups and blocks of 2 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
For being double-blind research, at the beginning of the study, the boxes of capsules will be coded in A and B by someone other than the researcher, so that the researcher and patients won't be informed about the type of capsules received by each group.
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
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.399
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Inflammatory marker IL-1β
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level by ELISA kit
2
Description
Adiponectin
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Measurement of serum level by ELISA kit
3
Description
Body Composition
Timepoint
Before intervention and 2 months after intervention
Method of measurement
By Tanita Body Analyzer
4
Description
Blood pressure
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Mercury barometer
5
Description
Depression
Timepoint
Before intervention and 2 months after intervention
Method of measurement
PHQ-9 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dry extract of fenugreek seeds of Barij Essence Company entitled "Glucorx B" (containing 46.4 micrograms of luteolin per tablet), in the form of three 335 mg tablets and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant menu will be taught to patients, along with nutritional recommendations.
Category
Treatment - Drugs
2
Description
Control group: This group will take three 335 mg placebo tablets, made of microcrystalline cellulose, prepared by Barij Essence Company and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant 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
Laleh Fakhr
Position
Master of Science 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
lalehfakhrnut@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh Fakhr
Position
Master of Science 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
lalehfakhrnut@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh Fakhr
Position
Master of Science 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
lalehfakhrnut@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