Cardiovascular and metabolic diseases in overweight and obese adults Not Applicable
Conditions
Interventions
Two-week, two-arm, parallel, unblinded, pilot randomised controlled trial investigating the impact of dietary nitrate along with caloric restriction on the metabolic and vascular function in 36 non-sm
or ii) caloric restriction alone (n = 18) groups.
Interventions: Each participant will be invited to start each intervention at the end of the baseline visit and continue for 14 days until they will
Sponsors
University of Naples Federico II
Eligibility
Sex/Gender
All
Inclusion 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
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) 11. Major surgical operations interfering with the study outcomes (systemic effects on study outcomes) 12. Alcohol intake >21 units/week for men and >14 units/week for women 13. Blood donations in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting energy expenditure measured by indirect calorimetry at baseline and at the end of the study (14 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and at the end of the study (14 days): 1. Body composition measured by bioelectrical impedance 2. Resting blood pressure measured by an automated blood pressure device 3. Endothelial function: microcirculation blood flow during post-reactive hyperaemia measured by laser doppler flowmetry 4. Cognitive function measured by Trail Making Test Part A and Part B 5. Physical function assessed by hand grip strength measured by a hand-held dynamometer 6. Laboratory biomarkers (nitrate, nitrite, markers of oxidative stress) measured using standardised laboratory protocols | — |
Countries
England, Italy, United Kingdom
Outcome results
None listed