The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk
Ключови думи
Резюме
Описание
To investigate the effect of Aronia (Aronia melanocarpa L.) juice polyphenols on platelet function and other CVD risk factors a three-arm, crossover design, randomized, double-blind placebo-controlled clinical trial will be performed in apparently healthy subjects at moderate CVD risk.
Recruited participants will be randomly assigned to one of three interventions (pure Aronia juice, Aronia beverage or placebo beverage) in the first phase and followed by cross-over in second and third phase. Two-week run-in period with low intake of polyphenols will precede the start of the intervention, ie. the first intervention phase. During each of three intervention periods (phases) subjects will consume 100 ml of each intervention product daily for 28 days, with 28 days of wash out period between different phases.
Blood and urine samples will be taken at baseline, before and after 28 days after each intervention period. Platelet analyses by flow cytometry, biochemical analyses of plasma samples, full blood count, blood pressure and anthropometric measurements will be performed at each study visit.
During the first study visit, regardless the allocation, blood samples will be taken before and 2h after the consumption of first 100 ml of intervention product (performed at the experimental site) and the analysis of markers of platelet function, biochemical parameters (glucose, triglycerides, and uric acid) and blood pressure will be assessed.
Subjects will be instructed to avoid rich-sources of anthocyanins and procyanidins during the whole study. Dietary habits will be assessed by food frequency questionnaire (FFQ) performed 2 times at the beginning and at the end of the study and 24h-recall performed at the beginning and after each wash out period.
Дати
| Последна проверка: | 09/30/2016 |
| Първо изпратено: | 06/02/2016 |
| Очаквано записване подадено: | 06/09/2016 |
| Първо публикувано: | 06/14/2016 |
| Изпратена последна актуализация: | 10/23/2016 |
| Последна актуализация публикувана: | 10/24/2016 |
| Действителна начална дата на проучването: | 12/31/2013 |
| Приблизителна дата на първично завършване: | 08/31/2016 |
| Очаквана дата на завършване на проучването: | 05/31/2017 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Pure Aronia juice
Dietary Supplement: Aronia juice-based beverage
Dietary Supplement: Placebo beverage
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: Pure Aronia juice Participants will consume 100 ml of pure Aronia juice per day for 28 days | Dietary Supplement: Pure Aronia juice Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml |
| Active Comparator: Aronia juice-based beverage Participants will consume 100 ml of Aronia juice-based beverage per day for 28 days. | Dietary Supplement: Aronia juice-based beverage Aronia juice-based beverage with appx. polyphenols content of 250 mg gallic acid equivalents/100ml, obtained as a blend of ¼ vol. of pure Aronia juice and ¾ vol. of placebo beverage. |
| Placebo Comparator: Placebo beverage Participants will consume 100 ml of Placebo beverage per day for 28 days | Dietary Supplement: Placebo beverage A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 30 Years Да се 30 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - BMI: 25-30 or - Central obesity ie. WC≥80 cm (women) and ≥94 cm (man) or - Normal (systolic blood pressure (SBP): 120-129; diastolic blood pressure(DBP): 80-84) or high normal (SBP:130-139; DBP:85-89) blood pressure Exclusion Criteria: - Smokers - Diagnosed with CVD, history of stroke or CVD - Diagnosis of type 2 diabetes mellitus on insulin therapy - Very low or high blood pressure (<90/50) - Pregnant or have been pregnant in the last 12 months or on oral contraceptives - Gastrointestinal diseases - Diagnosed with a long-term illness requiring active treatment, e.g. cancer, thyroid, adrenal, pituitary diseases - On regularly prescribed medication known to have a profound effect on CVD risk factors (including statins) - Non-steroidal anti-inflammatory drugs including creams - Sufferers of asthma and/or hay-fever - Known allergy to any of investigated polyphenol-rich food - Regularly using antacids and laxatives (at least once a week) - Unwillingness to discontinue specific dietary (other than vitamins and minerals) or herbal supplements less than one month prior to the start of the study and for the duration of the study - Unwillingness to restrict oily fish consumption to 2 portions or less per week less than one month prior to the start of the study and for the duration of the study - Taking paracetamol for more than one day during the intervention period and unwillingness to continue with the study intervention for an additional 48 hours if paracetamol is taken - Blood donation within 16 weeks of the first study sample and who intend to donate blood less than 16 weeks after the last study sample - Those who receive or plan to receive any type of immunization during the study period and those who have received an immunization within 4 weeks of the start of the study - Parallel participation in another research project which involves dietary intervention (e.g. taking vitamin supplements) or sampling of blood that may increase the total volume taken above 470 mL in a 4 month period |
Резултат
Първични изходни мерки
1. Changes in the percentage of P-selectin and glycoprotein IIbIIIa (GPIIbIIIa) positive platelets, percentage of platelet-monocyte and platelet-neutrophil aggregates, between baseline and endpoint within the intervention group vs. control group. [Baseline, 2 hours and 4 weeks]
Вторични изходни мерки
1. Changes in serum glucose levels between baseline and endpoint within the intervention group vs. control group. [Baseline, 2 hours and 4 weeks]
2. Changes in serum cholesterol levels between baseline and endpoint within the intervention group vs. control group. [Baseline and 4 weeks]
3. Changes in serum triglycerides levels between baseline and endpoint within the intervention group vs. control group. [Baseline, 2 hours and 4 weeks]
4. Changes in systolic and diastolic blood pressures between baseline and endpoint within the intervention group vs. control group. [Baseline, 2 hours and 4 weeks]
5. Changes in body weight between baseline and 4 weeks within the intervention group vs. control group. [Baseline and 4 weeks]
6. Changes in waist circumference between baseline and 4 weeks within the intervention group vs. control group. [Baseline and 4 weeks]
7. Changes in body mass index between baseline and 4 weeks within the intervention group vs. control group. [Baseline and 4 weeks]
8. Changes in the percentage of body fat between baseline and 4 weeks within the intervention group vs. control group [Baseline and 4 weeks]
9. Changes in the percentage of body water between baseline and 4 weeks within the intervention group vs. control group [Baseline and 4 weeks]
10. Changes in total body muscle mass between baseline and 4 weeks within the intervention group vs. control group [Baseline and 4 weeks]
Други изходни мерки
1. Changes in parameters of liver function between baseline and endpoint [Baseline and 4 weeks]
2. Changes in parameters of renal function between baseline and endpoint [Baseline and 4 weeks]
3. Changes in uric acid, iron and oxLDL level between baseline and endpoint within the intervention group vs. control group. [Baseline and 4 weeks]
4. Changes in full blood count between baseline and endpoint [Baseline and 4 weeks]
5. Changes in total caloric intake and intake of total polyphenols [Baseline and 4 weeks]
6. Changes in urine levels of major polyphenol metabolites between baseline and endpoint [Baseline, 2h and 4 weeks]
