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The Effect of High-Intensity Functional Training Combined with Terminalia chebula Supplementation on Nitric Oxide, C-Reactive Protein, Insulin Resistance, and Cardiometabolic Risk in Women with Metabolic Syndrome

Protocol summary

Study aim
The effect of high-intensity functional training combined with black cumin supplement on improving nitric oxide, C-reactive protein, insulin resistance, and cardiometabolic risk in women with metabolic syndrome.
Design
Simple random sampling was performed with a sample size of 60 women with metabolic syndrome using G Power software. The subjects were aged 35 to 45 and divided into 4 groups (supplement, exercise, control, supplement and exercise).
Settings and conduct
The subjects will be under research interventions for 8 weeks. Before and after 8 weeks, the desired factors will be measured to obtain results. The research will be conducted in Fars Province, Eghlid City, Rastegar Laboratory and Kargan Sports Hall.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the present study were waist circumference greater than 88 cm, blood triglyceride level greater than 150 mg/dL, HDL level less than 50 mg/dL, systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 85 mmHg, and blood glucose level greater than 100 mg/dL. Inactivity, non-smoking, and alcohol consumption were other inclusion criteria for the present study.Also, if the subjects have cardiovascular, respiratory, renal, or neurological disorders, they will not be allowed to enter the research.
Intervention groups
Terminalia chebula supplementation in two groups (supplement and exercise and supplement) High-intensity functional training (exercise, supplement and exercise)
Main outcome variables
on Nitric Oxide, C-Reactive Protein, Insulin Resistance, and Cardiometabolic Risk

General information

Reason for update
Acronym
TC. HIFT. Mets
IRCT registration information
IRCT registration number: IRCT20251104067880N1
Registration date: 2025-11-14, 1404/08/23
Registration timing: prospective

Last update: 2025-11-14, 1404/08/23
Update count: 0
Registration date
2025-11-14, 1404/08/23
Registrant information
Name
Fatemeh Esmaeili
Name of organization / entity
Al-zahra University, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 71 4434 0448
Email address
faatemeh.esmaeili2024@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High-Intensity Functional Training Combined with Terminalia chebula Supplementation on Nitric Oxide, C-Reactive Protein, Insulin Resistance, and Cardiometabolic Risk in Women with Metabolic Syndrome
Public title
Investigating the effect of high-intensity functional training combined with Terminalia chebula supplementation in women with metabolic syndrome.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the present study were waist circumference greater than 88 cm, blood triglyceride level greater than 150 mg/dL, HDL level less than 50 mg/dL, systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 85 mmHg, and blood glucose level greater than 100 mg/dL. Failure to attend more than three training sessions, unwillingness to continue participating in the study, failure to take supplements regularly, and physical injury were exclusion criteria.
Exclusion criteria:
Subjects will not be included in the study if they have the following conditions: smoking and alcohol consumption, history of or suffering from any heart, lung, kidney, liver or neurological disease.
Age
From 35 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. According to the call for volunteers to participate in the study (women with metabolic syndrome), blood tests and the desired factors were measured. We placed the people in 4 groups of 15 people without regard to specific criteria and with completely equal chances. (That is, the people in the exercise or supplemental exercise or mock or control group are no different from each other.)
Blinding (investigator's opinion)
Single blinded
Blinding description
those responsible for data collection, such as the nurse responsible for blood tests, do not know who is in the control, exercise, supplement, and supplement and exercise groups.
Placebo
Not used
Assignment
Factorial
Other design features
The current study includes exercise and herbal supplementation to improve metabolic health in people with metabolic syndrome.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته تخصصی اخلاق در پژوهش های زیست پزشکی
Street address
Alzahra University Deh Vanek St.
City
Tehran
Province
Tehran
Postal code
1993891176
Approval date
2025-10-04, 1404/07/12
Ethics committee reference number
IR.ALZAHRA.REC.1404.075

Health conditions studied

1

Description of health condition studied
Women with metabolic syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nitric oxide, C-reactive protein, insulin resistance, and cardiometabolic risk are not balanced and optimal.
Timepoint
Measurements of all factors considered are measured on two days (the first day for blood factors and the second day for physical performance) before and after 8 weeks.
Method of measurement
Nitric oxide, C-reactive protein, and insulin resistance are measured with blood tests, and cardiometabolic risk is measured using blood pressure measurements, waist circumference to height, and the Cooper test to measure aerobic capacity.

Secondary outcomes

empty

Intervention groups

1

Description
Exercise group. Supplement group. Exercise and supplement group. Control group. Interventions are applied to the first three groups for 8 weeks. 3 training sessions per week and 500 mg supplement capsules are taken twice a day for 8 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
آزمایشگاه رستگار
Full name of responsible person
Fatemeh Esmaeili
Street address
Eqlid County. Rastegar Laboratory. Valiasr Street.
City
Eqlid
Province
Fars
Postal code
1111111111
Phone
+98 71 4434 0448
Email
fatemehesmaeili7762@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alzahra University, Tehran
Full name of responsible person
Vice President for Research, Al-Zahra University
Street address
Deh Vanak Street
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 71 4434 0448
Email
fatemhesmaeili7762@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
do not have
Proportion provided by this source
1
Public or private sector
Private
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
Alzahra University, Tehran
Full name of responsible person
Fatemeh Esmaeili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Deh Vanak Street
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 71 4434 0448
Email
fateehesmaeili7762@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra University, Tehran
Full name of responsible person
Fatemeh Esmaeili
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Deh Vanak Street
City
tehran
Province
Tehran
Postal code
1993891176
Phone
+98 71 4434 0448
Email
fatemehesmaeili7762@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alzahra University, Tehran
Full name of responsible person
Fatemeh Esmaeili
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Deh Vanak Street
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 71 4434 0448
Email
fatemehesmaeili7762@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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