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Effect of beetroot extract on cardiovascular factors in men with metabolic syndrome

Evaluation of the effect of non-organic nitrate supplementation on macro-and micro-vascular changes in active and inactive men with metabolic syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220101053579N1
Enrollment
60
Registered
2022-01-12
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: Intervention group 1: Physical activity intervention will be conducted using low volume high intensity interval training method. Due to the COVID-19 pandemic, instructions will be prov

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study by signing an informed consent Age between 18 and 40 years old Diagnosis of metabolic syndrome based on the International Diabetes Federation (IDF) criteria Low to moderate level of physical activity based on the International Physical Activity Questionnaire (IPAQ) No history for chronic diseases (Diabetes Mellitus, heart failure) No history for Rheumatologic or joint disorders that impair the ability of performing exercises No history for underlying diseases that may affect metabolic syndrome (Cushing syndrome, Addison's disease) No history for hypertension, diabetes and dyslipidemia Male gender

Exclusion criteria

Exclusion criteria: Using medications that affect metabolic syndrome (chemotherapy, corticosteroids) Cancer Physical disability that prevents performing the exrcises Mental or psychological disorders that prevent performing the study protocol

Design outcomes

Primary

MeasureTime frame
Mean pulse wave velocity. Timepoint: Baseline and the end of study (4th week). Method of measurement: PWV at the bifurcation of carotid artery using Doppler ultrasound.;Augmentation index (AI). Timepoint: Baseline and the end of study (4th week). Method of measurement: PWV using Doppler ultrasound.;Avascular area. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.;Increase in the diameter of the capillaries. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.;Microhaemorrhage. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.;Hairpin structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.;Tortuous structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.;Crossing structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy.

Secondary

MeasureTime frame
Fasting blood sugar. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample.;Total cholesterol. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample.;Serum triglyceride. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample.;Low-density lipoprotein (LDL). Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample.;High density lipoprotein (HDL). Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample.;Serum nitrate. Timepoint: Weekly from the beginning of the study. Method of measurement: Measuring serum nitrate using nitrate kit.;Step test. Timepoint: Baseline and at the end of the study. Method of measurement: Measured using a standard step.;Systolic blood pressure. Timepoint: Weekly from the beginning of the study. Method of measurement: Measured using sphygmomanometer.;Diastolic blood pressure. Timepoint: Weekly from the beginning of the study. Method of measurement: Measured using sphygmomanometer.;VO2Max. Timepoint: Baseline, second week, and at the end of the study. Method of measurement: Measured on treadmill using CPET device.;Dietary intake. Timepoint: Weekly from the beginning of the study. Method of measurement: 3-day 24-hour recall.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Jafarzadeh Esfehani

Mashhad University of Medical Sciences

JafarzadehEA982@mums.ac.ir+98 51 3882 7034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026