Combined effects of nitrate-rich beetroot juice and low calorie diet on metabolic and vascular function in overweight middle-aged and older people

Not Applicable

Completed

• Conditions: Cardiovascular and metabolic diseases in overweight and obese adults; Not Applicable

• Registration Number: ISRCTN59029976
• Lead Sponsor: niversity of Naples Federico II

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-31
• Study Start: 2022-12-28
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

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)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified