Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers
Ключови думи
Резюме
Описание
More than 31% of Connecticut adults are former smokers, which may contribute to the high cardiovascular disease (CVD) risk in this state. Atherosclerosis, a hallmark of CVD, is a progressive life-long process. Chronic cigarette smoking increases atherosclerosis and CVD risk. While smoking cessation may lower CVD risk, former smokers still are at high CVD risk. The mechanisms by which smoking accelerates atherosclerosis formation are not fully understood. This knowledge gap prevents development of informed interventions to reduce CVD risk in former smokers.
Previous work suggests smoking increases oxidative stress and leads to elevated CVD risk. Former smokers also have decreased antioxidants and markers of vascular function in the circulation, suggesting that despite cessation, smoking has a lingering adverse effect on CVD protective mechanisms. Chokeberry (Aronia melanocarpa) is a native Connecticut plant rich in polyphenol antioxidants and is a promising intervention for reducing CVD risk in former smokers. Chokeberries have diverse polyphenols such as anthocyanins, proanthocyanidins, resveratrol, quercetin, and chlorogenic acid. Chokeberry consumption improves dyslipidemia, inhibits inflammation, and reduces oxidative stress in humans and animals, all of which could contribute to the prevention of CVD in former smokers. Therefore, our central hypothesis is that dietary chokeberry polyphenols reduce CVD risk in former smokers by improving lipid profiles and inhibiting inflammation and oxidative stress. Our long-term goal is to define the mechanisms by which polyphenol antioxidants mitigate CVD risk. The overall goal of this project is to conduct a randomized placebo-controlled clinical trial to evaluate the cardio-protective effects of dietary chokeberry polyphenols in former smokers.
Our objectives are to determine 1) the effect of chokeberry polyphenols on plasma cholesterol and triglyceride levels and on gene expression involved in cholesterol metabolism; 2) the extent to which chokeberry improves antioxidant and vascular function in former smokers; and 3) the association of bioavailability of chokeberry polyphenols to changes in biomarkers of CVD risk.
Successful completion of this work will result in improved understanding of the role of dietary berry polyphenols to regulate lipid metabolism, inflammation and oxidative stress. Thus, this study will be an important step to developing dietary recommendations for individuals predisposed to CVD risk, particularly former smokers.
Дати
| Последна проверка: | 03/31/2017 |
| Първо изпратено: | 02/23/2012 |
| Очаквано записване подадено: | 02/28/2012 |
| Първо публикувано: | 02/29/2012 |
| Изпратена последна актуализация: | 04/11/2017 |
| Последна актуализация публикувана: | 07/10/2017 |
| Дата на първите подадени резултати: | 12/11/2016 |
| Дата на първите подадени резултати от QC: | 04/11/2017 |
| Дата на първите публикувани резултати: | 07/10/2017 |
| Действителна начална дата на проучването: | 01/31/2012 |
| Приблизителна дата на първично завършване: | 07/31/2015 |
| Очаквана дата на завършване на проучването: | 11/30/2016 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Chokeberry extract capsule
Dietary Supplement: Color-matched rice powder pill
Dietary Supplement: Chokeberry extract capsule (acute)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Placebo Comparator: Color-matched rice powder pill Color-matched rice powder pill | Dietary Supplement: Color-matched rice powder pill Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks |
| Active Comparator: Chokeberry extract capsule Chokeberry extract capsule | Dietary Supplement: Chokeberry extract capsule Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Experimental: Chokeberry extract capsule (acute) Chokeberry extract capsule pharmacokinetics | Dietary Supplement: Chokeberry extract capsule (acute) Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Former smoker (previously smoked ≥3 cigarettes/day for at least 1 year, cessation for at least 6 months - Healthy male or female between 18-65 y - Serum clinical ranges no more than mildly elevated (serum cholesterol <240 mg/dL) and serum triglyceride (<150 mg/dL) - Resting blood pressure <140/90 mm Hg - Stable body weight (±5 lb) for last 2 months - BMI ranges within normal and overweight (18.5-39 kg/m2) - Willing to maintain normal exercise level (<7 h/wk) - Willing to avoid exercise 24 h prior to blood sampling - Willing to ingest a dietary chokeberry supplement or placebo (500 mg/d) daily for 12 wks. Exclusion Criteria: - Previous diagnoses of CVD, diabetes, or arthritis (except for osteo-arthritis) - Currently being treated for cancer (i.e., chemotherapy, radiation therapy) - Women with prescribed estrogen replacement therapy - Practicing slimming diet - Practicing vegetarian diet - Currently taking vitamin or mineral supplements or plant pills - Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day or a total of 12/week for men or 1 drink/day or a total of 7/week for women) |
Резултат
Първични изходни мерки
1. LDL Cholesterol [Baseline, 6 weeks, 12 weeks of intervention]
Вторични изходни мерки
1. Total Cholesterol [6 and 12 weeks after supplementation]
2. HDL-cholesterol [6 and 12 weeks after supplementation]
3. Triglycerides [6 and 12 weeks after supplementation]
4. Resting Systolic Blood Pressure [Baseline, 6 weeks, and 12 weeks following intervention]
5. Resting Diastolic Blood Pressure [Baseline, 6 weeks, and 12 weeks following intervention]
6. Urinary F2-isoprostanes [Baseline and 12 weeks following intervention]
7. 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) [Baseline, 12 wk]
8. LDL Receptor (LDLR) [Change from baseline at 12 weeks]
9. LDL Receptor (LDLR) Protein [Baseline, 12 weeks]
10. Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. [0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose]
11. Urinary Excretion of Polyphenols [0 to 24 h after consumption of extract]
12. Adiponectin [Baseline, 6 weeks, 12 weeks]
13. Interleukin-1 Beta [Baseline, 6 weeks, 12 weeks]
14. Interleukin-6 [Baseline, 6 weeks, 12 weeks]
15. Monocyte Chemoattractant Protein-1 [Baseline, 6 weeks, 12 weeks]
16. Tumor Necrosis Factor-alpha [Baseline, 6 weeks, 12 weeks]
17. C-reactive Protein [Baseline, 6 weeks, 12 weeks]
18. Intercellular Adhesion Molecule 1 [Baseline, 6 weeks, 12 weeks]
19. Soluble Vascular Cell Adhesion Molecule 1 [Baseline, 6 weeks, 12 weeks]
20. P-selectin [Baseline, 6 weeks, 12 weeks]
21. Total Antioxidant Capacity [Baseline, 6 weeks, 12 weeks]
22. Catalase Activity [Baseline, 6 weeks, 12 weeks]
23. Glutathione Peroxidase Activity [Baseline, 6 weeks, 12 weeks]
24. Superoxide Dismutase Activity [Baseline, 6 weeks, 12 weeks]
25. Urinary Polyphenol Excretion [12 weeks]
26. Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber [Baseline, 12 weeks]
27. Energy Intake [Baseline, 12 weeks]
28. Energy-adjusted Micronutrient Intake [Baseline, 12 weeks]
29. Polyphenol Intake [Baseline, 12 weeks]
30. Intake of Dietary Antioxidant Capacity [Baseline, 12 weeks]
31. Energy-adjusted Vitamin A Intake [Baseline, 12 weeks]
