Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers

NCT ID: NCT01541826

Last Updated: 2017-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.

Detailed Description

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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.

Conditions

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Cardiovascular Disease Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Color-matched rice powder pill

Color-matched rice powder pill

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry extract capsule

Chokeberry extract capsule

Group Type ACTIVE_COMPARATOR

Chokeberry Extract

Intervention Type DIETARY_SUPPLEMENT

Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.

Chokeberry extract capsule (acute)

Chokeberry extract capsule pharmacokinetics

Group Type EXPERIMENTAL

Chokeberry extract capsule, acute

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Chokeberry extract capsule, acute

Chokeberry extract capsule, 2 x 250 mg, one-time dose.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Bradley Bolling

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 27283706 (View on PubMed)

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.

Reference Type RESULT
PMID: 28215316 (View on PubMed)

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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