Cardiovascular DiseaseNCT01541826
Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers
A study testing Chokeberry Extract and Chokeberry extract capsule, acute in people with Cardiovascular Disease and Oxidative Stress, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Oxidative Stress
- What is being tested?
- Chokeberry Extract and Chokeberry extract capsule, acute
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chokeberry Polyphenols on Biomarkers of Cardiovascular Disease and Antioxidant Defenses in Former Smokers
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
Read the detailed description
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
- Cardiovascular Disease, Oxidative Stress
- Being tested
- Chokeberry Extract, Placebo capsule, Chokeberry extract capsule, acute
- Keywords
- aronia, LDL cholesterol, polyphenols, bioavailability, oxidative stress
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chokeberry ExtractDietary supplement
Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Placebo capsuleDietary supplement
Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
Chokeberry extract capsule, acuteDietary supplement
Chokeberry extract capsule, 2 x 250 mg, one-time dose.
| Study group | Role | What they receive |
|---|---|---|
| Color-matched rice powder pill | Placebo comparator | Color-matched rice powder pill Receives: Dietary Supplement: Placebo capsule |
| Chokeberry extract capsule | Active comparator | Chokeberry extract capsule Receives: Dietary Supplement: Chokeberry Extract |
| Chokeberry extract capsule (acute) | Experimental | Chokeberry extract capsule pharmacokinetics Receives: Dietary Supplement: Chokeberry extract capsule, acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
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.
Measured: Baseline, 6 weeks, 12 weeks of intervention
Secondary outcomes (31)
Total Cholesterol
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.
Measured: 6 and 12 weeks after supplementation
HDL-cholesterol
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.
Measured: 6 and 12 weeks after supplementation
Triglycerides
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.
Measured: 6 and 12 weeks after supplementation
Resting Systolic Blood Pressure
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.
Measured: Baseline, 6 weeks, and 12 weeks following intervention
Resting Diastolic Blood Pressure
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.
Measured: Baseline, 6 weeks, and 12 weeks following intervention
Urinary F2-isoprostanes
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.
Measured: Baseline and 12 weeks following intervention
3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
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.
Measured: Baseline, 12 wk
LDL Receptor (LDLR)
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.
Measured: Change from baseline at 12 weeks
LDL Receptor (LDLR) Protein
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.
Measured: Baseline, 12 weeks
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
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).
Measured: 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose
Urinary Excretion of Polyphenols
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.
Measured: 0 to 24 h after consumption of extract
Adiponectin
Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Interleukin-1 Beta
Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Interleukin-6
Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Monocyte Chemoattractant Protein-1
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.
Measured: Baseline, 6 weeks, 12 weeks
Tumor Necrosis Factor-alpha
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.
Measured: Baseline, 6 weeks, 12 weeks
C-reactive Protein
Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Intercellular Adhesion Molecule 1
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.
Measured: Baseline, 6 weeks, 12 weeks
Soluble Vascular Cell Adhesion Molecule 1
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.
Measured: Baseline, 6 weeks, 12 weeks
P-selectin
Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Total Antioxidant Capacity
Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Catalase Activity
Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Glutathione Peroxidase Activity
Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Superoxide Dismutase Activity
Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: Baseline, 6 weeks, 12 weeks
Urinary Polyphenol Excretion
Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Measured: 12 weeks
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
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.
Measured: Baseline, 12 weeks
Energy Intake
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.
Measured: Baseline, 12 weeks
Energy-adjusted Micronutrient Intake
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.
Measured: Baseline, 12 weeks
Polyphenol Intake
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.
Measured: Baseline, 12 weeks
Intake of Dietary Antioxidant Capacity
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.
Measured: Baseline, 12 weeks
Energy-adjusted Vitamin A Intake
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Bolling, University of Connecticut
- Investigators
- Bradley W Bolling, PhD, Principal investigator, University of Connecticut, University of Wisconsin-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541826
- Sponsor's protocol ID
- H11-311
- Other IDs
- 120068
- Status last verified
- Apr 2017
- First submitted
- 24 Feb 2012
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27283706Xie 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.
PubMed 28215316
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chokeberry Polyphenols on Biomarkers of Cardiovascular Disease and Antioxidant Defenses in Former Smokers
- ClinicalTrials.gov ID
- NCT01541826
- Acronym / sponsor ID
- H11-311
- Conditions
- Cardiovascular Disease, Oxidative Stress
- Keywords
- aronia, LDL cholesterol, polyphenols, bioavailability, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Color-matched rice powder pill | Placebo comparator | Dietary Supplement: Placebo capsuleColor-matched rice powder pill |
| Chokeberry extract capsule | Active comparator | Dietary Supplement: Chokeberry ExtractChokeberry extract capsule |
| Chokeberry extract capsule (acute) | Experimental | Dietary Supplement: Chokeberry extract capsule, acuteChokeberry extract capsule pharmacokinetics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chokeberry ExtractConsumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. | Dietary supplement | Chokeberry extract capsule |
| Placebo capsuleColor-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Dietary supplement | Color-matched rice powder pill |
| Chokeberry extract capsule, acuteChokeberry extract capsule, 2 x 250 mg, one-time dose. | Dietary supplement | Chokeberry extract capsule (acute) |
Primary outcome
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.
31 secondary outcomes
Total Cholesterol
Time frame: 6 and 12 weeks after supplementation
HDL-cholesterol
Time frame: 6 and 12 weeks after supplementation
Triglycerides
Time frame: 6 and 12 weeks after supplementation
Resting Systolic Blood Pressure
Time frame: Baseline, 6 weeks, and 12 weeks following intervention
Resting Diastolic Blood Pressure
Time frame: Baseline, 6 weeks, and 12 weeks following intervention
Urinary F2-isoprostanes
Time frame: Baseline and 12 weeks following intervention
3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
Time frame: Baseline, 12 wk
LDL Receptor (LDLR)
Time frame: Change from baseline at 12 weeks
LDL Receptor (LDLR) Protein
Time frame: Baseline, 12 weeks
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
Urinary Excretion of Polyphenols
Time frame: 0 to 24 h after consumption of extract
Adiponectin
Time frame: Baseline, 6 weeks, 12 weeks
Interleukin-1 Beta
Time frame: Baseline, 6 weeks, 12 weeks
Interleukin-6
Time frame: Baseline, 6 weeks, 12 weeks
Monocyte Chemoattractant Protein-1
Time frame: Baseline, 6 weeks, 12 weeks
Tumor Necrosis Factor-alpha
Time frame: Baseline, 6 weeks, 12 weeks
C-reactive Protein
Time frame: Baseline, 6 weeks, 12 weeks
Intercellular Adhesion Molecule 1
Time frame: Baseline, 6 weeks, 12 weeks
Soluble Vascular Cell Adhesion Molecule 1
Time frame: Baseline, 6 weeks, 12 weeks
P-selectin
Time frame: Baseline, 6 weeks, 12 weeks
Total Antioxidant Capacity
Time frame: Baseline, 6 weeks, 12 weeks
Catalase Activity
Time frame: Baseline, 6 weeks, 12 weeks
Glutathione Peroxidase Activity
Time frame: Baseline, 6 weeks, 12 weeks
Superoxide Dismutase Activity
Time frame: Baseline, 6 weeks, 12 weeks
Urinary Polyphenol Excretion
Time frame: 12 weeks
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Time frame: Baseline, 12 weeks
Energy Intake
Time frame: Baseline, 12 weeks
Energy-adjusted Micronutrient Intake
Time frame: Baseline, 12 weeks
Polyphenol Intake
Time frame: Baseline, 12 weeks
Intake of Dietary Antioxidant Capacity
Time frame: Baseline, 12 weeks
Energy-adjusted Vitamin A Intake
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27283706Xie 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.
- Results publication: PubMed 28215316Xie 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.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley W Bolling, PhD principal investigator
University of Connecticut, University of Wisconsin-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chokeberry Extract and Chokeberry extract capsule, acute in people with Cardiovascular Disease and Oxidative Stress, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL Cholesterol (time frame: Baseline, 6 weeks, 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01541826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.