A pilot randomized controlled study to evaluate the effect of inorganic nitrate supplementation during caloric restriction on energy metabolism, vascular health and cognition in overweight and obese subjects

niversity of Naples Federico II0 sites29 target enrollmentDecember 28, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity of Naples Federico II
Enrollment: 29
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36839248/ (added 29/12/2023)

Registry

who.int

Start Date

December 28, 2022

End Date

December 31, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Naples Federico II

Eligibility Criteria

Inclusion Criteria

•1\. Males and females aged 50 \- 75 years
•2\. Overweight and obese subjects (BMI range: 25\-40 kg/m²)
•3\. Non\-smokers
•4\. Weight stable

Exclusion Criteria

•1\. Current participation in other research clinical studies
•2\. Vegetarianism (likely to have very high nitrate intake)
•3\. Weight change more than 3\.0 kg in the last 2 months (important influence on systemic metabolism and vascular function)
•4\. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes)
•5\. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example, flu, Crohn’s disease, rheumatoid arthritis
•6\. Previous diagnosis of type 1 or type 2 diabetes treated with insulin (modification of regulation of intermediate metabolism). Type 2 diabetic patients treated with diet only or and oral hypoglycaemic agents with dose stable for at least 3 months will be included in the study
•7\. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
•8\. Drugs: corticosteroids, sildenafil, aspirin, NSAIDs, diuretics, antacids, anticoagulants, nitrate\-derived agents, anti\-cholinergic, (all drugs may have either an effect on NO production or insulin sensitivity via different mechanisms)
•9\. Subjects on hormonal therapies (oestrogens, thyroxine, progesteron), anti\-hypertensive (Ca\+\+ channel blockers, ACE inhibitors, beta\-blockers,), statins and any other antidyslipidaemic agent, and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if the dose has been started/changed in the previous 3 months (make sure that these disorders are under strict control to avoid interference with the study outcomes)
•10\. Severe haematological disorders (risk for the participant and effects on the study outcomes)