Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers
NCT ID: NCT01541826
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2012-02-29
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Color-matched rice powder pill
Color-matched rice powder pill
Placebo capsule
Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
Chokeberry extract capsule
Chokeberry extract capsule
Chokeberry Extract
Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Chokeberry extract capsule (acute)
Chokeberry extract capsule pharmacokinetics
Chokeberry extract capsule, acute
Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Interventions
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Chokeberry Extract
Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Placebo capsule
Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
Chokeberry extract capsule, acute
Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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University of Connecticut
OTHER
Responsible Party
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Bradley Bolling
Assistant Professor
Principal Investigators
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Bradley W Bolling, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Connecticut, University of Wisconsin-Madison
Locations
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Roy E. Jones Building
Storrs, Connecticut, United States
Countries
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References
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Xie L, Lee SG, Vance TM, Wang Y, Kim B, Lee JY, Chun OK, Bolling BW. Bioavailability of anthocyanins and colonic polyphenol metabolites following consumption of aronia berry extract. Food Chem. 2016 Nov 15;211:860-8. doi: 10.1016/j.foodchem.2016.05.122. Epub 2016 May 19.
Xie L, Vance T, Kim B, Lee SG, Caceres C, Wang Y, Hubert PA, Lee JY, Chun OK, Bolling BW. Aronia berry polyphenol consumption reduces plasma total and low-density lipoprotein cholesterol in former smokers without lowering biomarkers of inflammation and oxidative stress: a randomized controlled trial. Nutr Res. 2017 Jan;37:67-77. doi: 10.1016/j.nutres.2016.12.007. Epub 2016 Dec 10.
Other Identifiers
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120068
Identifier Type: OTHER
Identifier Source: secondary_id
H11-311
Identifier Type: -
Identifier Source: org_study_id
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