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

Evaluating the effect of inorganic nitrate supplementation with or without physical activity on micro- and macro-vascular status of men with metabolic syndrome

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).

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.

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 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.

PWV, nail fold capillaroscopy

Randomization will be performed based on stratified block randomization. Block size would be 8 and participants will be randomized into each block based on age (below 30, 30 or above), BMI (below 30 kg/m2, 30 kg/m2 or over), and presence of elevated blood pressure (below 130/85 mmHg, 130/85 mmHg or over). Randomization concealment will be performed using sealed envelops. One of the research team members will perform the concealment based on the randomization list. Envelops will be opaque and sealed so that other researchers and the participants will not be aware of their group allocation.

Persian cohort center will provide the data to researchers in a case-by-case basis and the center has the complete ownership of the data.

Some collected data including the results of primary outcome measures will be presented.

Access to data will be granted 6 months after publication

Data will be accessible for people working in academic institutions and people working in businesses upon request.

Criteria for sharing deidentified data or other products will be evaluated based on case-by-case approach by the Mashhad University of Medical Sciences.

Contact info: Dr. Mohsen Nemati, Department of Nutrition, Mashhad University of Medical Sciences, East door of Ferdowsi University, Azadi Sq., Mashhad, Iran Post code: 9177948564 email: NematyM@mums.ac.ir Phone number: 0098 51 38827034

Applicants should submit their detailed request through email. Their request will be evaluated by the researchers and the Mashhad University of Medical Sciences and will be available to the applicant if approved by the organization.