Study aim:
Evaluating the effect of inorganic nitrate supplementation with or without physical activity on micro- and macro-vascular status of men with metabolic syndrome
Design:
A single center, concealed, randomised, non-blinded, no placebo, controlled trial will be conducted based on parallel group design of 60 participants (15 in each group).
Settings and conduct:
Fasting blood sugar, lipid profile, CRP, blood pressure, physical fitness test, pulse wave velocity (PWV) and capilaroscopy will be performed at baseline and at the end of study. IPAQ, Vo2Max and 24-hour urine nitrate will be evaluated at baseline. Height, weight, waist circumference, bioelectric impedance analysis, serum nitrate, 3-day diet recall, step test, and blood pressure will be evaluated weekly.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: Willingness to participate in the study, male gender, age >18 till 40 years old, metabolic syndrome diagnosis based on IDF criteria, light to moderate physical activity level based on IPAQ
Non-inclusion criteria: Chronic diseases (Diabetes, heart failure), rheumatologic or articular disorders that prevent exercise performance, underlying diseases (Cushing's syndrome, Addison's disease), hypertension, diabetes, and dyslipidemia
exclusion criteria: Consuming medications that affect metabolic syndrome (chemotherapy, corticosteroids), cancer, physical disability, mental or psychological disorders that prevent exercise performance
Intervention groups:
Intervention groups will receive either beetroot extract (30% ADI divided dose twice/week), exercise intervention (high intensity interval training), or combined beetroot extract and exercise and the control group will receive general instruction on healthy lifestyle for 4 weeks. All participants will be instructed to limit the intake of dietary sources of inorganic nitrate.
Main outcome variables:
PWV, nail fold capillaroscopy
IRCTID: IRCT20220101053579N1