Anthocyanin-rich Blackcurrant and Vascular Function
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 01/31/2016 |
| Primero enviado: | 05/19/2015 |
| Inscripción estimada enviada: | 05/31/2015 |
| Publicado por primera vez: | 06/01/2015 |
| Última actualización enviada: | 02/07/2016 |
| Última actualización publicada: | 02/08/2016 |
| Fecha de inicio real del estudio: | 05/31/2015 |
| Fecha estimada de finalización primaria: | 10/31/2015 |
| Fecha estimada de finalización del estudio: | 10/31/2015 |
Condición o enfermedad
Intervención / tratamiento
Other: Intervention
Other: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Intervention Spray dried blackcurrant powder dissolved in water | Other: Intervention |
| Placebo Comparator: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) | Other: Placebo |
Criterio de elegibilidad
| Edades elegibles para estudiar | 30 Years A 30 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Aged 30-55 years - Non-smoker - BMI between 20 - 30 kg/m2 - Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample - Blood pressure < 140/90mmHg - Total cholesterol < 6.2 mmol/L - Fasting glucose < 7.0 mmol/L Exclusion Criteria: - Diabetes mellitus - Heart problems, stroke, vascular disease - Inflammatory disease - Kidney, liver, pancreas or gastrointestinal diseases - Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions - Asthma - Allergies - Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded) - Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period) - Taking aspirin > 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit - History of alcohol misuse - Consumption of alcohol >21 units (men) or >15 units (women) - Vegans - Intense aerobic exercise >20 min 3 x per week - Participation in another clinical trial - Antibiotics in previous 3 months before study - Low haemoglobin levels - Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence) |
Salir
Medidas de resultado primarias
1. Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD) [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention]
2. Change from baseline in platelet function measured by agonist-induced platelet aggregation [Acute study: measured at baseline and 2 and 4 h post intervention]
Medidas de resultado secundarias
1. Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS [Acute study: plasma measured at baseline and 1, 2, 4, 6 and 24 h post intervention, urine measured at baseline and 1, 2, 4, 6 and 6-24 h post intervention]
2. Change from baseline in vascular function measured by digital volume pulse (DVP) [Acute study: measured at baseline and 2, 4 and 6 h post intervention]
3. Change from baseline in blood pressure [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention]
4. Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention]
5. Change from baseline in the concentration of selected cytokines (TNF-a, IL-1b, IL-6, IL-8 and IL-10) in plasma measured using a cytometric bead array kit from BD Biosciences [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention]
6. Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis) [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)]
7. Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy [Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)]
