Skip to main content
OpenTrials
Completed

NCT Number: NCT01541826

Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Oxidative Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roy E. Jones Building

Storrs, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chokeberry Extract

Dietary Supplement

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

placebo capsule

Dietary Supplement

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

Chokeberry extract capsule, acute

Dietary Supplement

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

Primary outcomes

  1. LDL Cholesterol

    Time frame: Baseline, 6 weeks, 12 weeks of intervention

    Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

Secondary outcomes

  1. Total Cholesterol

    Time frame: 6 and 12 weeks after supplementation

    Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  2. HDL-cholesterol

    Time frame: 6 and 12 weeks after supplementation

    Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  3. Triglycerides

    Time frame: 6 and 12 weeks after supplementation

    Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  4. Resting Systolic Blood Pressure

    Time frame: Baseline, 6 weeks, and 12 weeks following intervention

    Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  5. Resting Diastolic Blood Pressure

    Time frame: Baseline, 6 weeks, and 12 weeks following intervention

    Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  6. Urinary F2-isoprostanes

    Time frame: Baseline and 12 weeks following intervention

    Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  7. 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)

    Time frame: Baseline, 12 wk

    Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  8. LDL Receptor (LDLR)

    Time frame: Change from baseline at 12 weeks

    Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  9. LDL Receptor (LDLR) Protein

    Time frame: Baseline, 12 weeks

    Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  10. Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.

    Time frame: 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose

    Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).

  11. Urinary Excretion of Polyphenols

    Time frame: 0 to 24 h after consumption of extract

    Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.

  12. Adiponectin

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  13. Interleukin-1 Beta

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  14. Interleukin-6

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  15. Monocyte Chemoattractant Protein-1

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  16. Tumor Necrosis Factor-alpha

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  17. C-reactive Protein

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  18. Intercellular Adhesion Molecule 1

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  19. Soluble Vascular Cell Adhesion Molecule 1

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  20. P-selectin

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  21. Total Antioxidant Capacity

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  22. Catalase Activity

    Time frame: Baseline, 6 weeks, 12 weeks

    Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  23. Glutathione Peroxidase Activity

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  24. Superoxide Dismutase Activity

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  25. Urinary Polyphenol Excretion

    Time frame: 12 weeks

    Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  26. Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber

    Time frame: Baseline, 12 weeks

    Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  27. Energy Intake

    Time frame: Baseline, 12 weeks

    Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  28. Energy-adjusted Micronutrient Intake

    Time frame: Baseline, 12 weeks

    Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  29. Polyphenol Intake

    Time frame: Baseline, 12 weeks

    Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  30. Intake of Dietary Antioxidant Capacity

    Time frame: Baseline, 12 weeks

    Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

  31. Energy-adjusted Vitamin A Intake

    Time frame: Baseline, 12 weeks

    Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

The Effect of Chokeberry Polyphenols on Biomarkers of Cardiovascular Disease and Antioxidant Defenses in Former Smokers

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 1, 2012
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.