Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers

NCT01541826 | Completed Results

• 2 other identifiers: H11-311120068
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Disease; Oxidative Stress

Keywords

aronia; LDL cholesterol; polyphenols; bioavailability; oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, 12 weeks of intervention

Secondary Outcomes (31)

• Total Cholesterol

  6 and 12 weeks after supplementation

• HDL-cholesterol

  6 and 12 weeks after supplementation

• Triglycerides

  6 and 12 weeks after supplementation

• Resting Systolic Blood Pressure

  Baseline, 6 weeks, and 12 weeks following intervention

• Resting Diastolic Blood Pressure

  Baseline, 6 weeks, and 12 weeks following intervention

Study Arms (3)

Color-matched rice powder pill

PLACEBO COMPARATOR

Color-matched rice powder pill

Dietary Supplement: Placebo capsule

Chokeberry extract capsule

ACTIVE COMPARATOR

Chokeberry extract capsule

Dietary Supplement: Chokeberry Extract

Chokeberry extract capsule (acute)

EXPERIMENTAL

Chokeberry extract capsule pharmacokinetics

Dietary Supplement: Chokeberry extract capsule, acute

Interventions

Chokeberry Extract DIETARY_SUPPLEMENT

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

Chokeberry extract capsule

Placebo capsule DIETARY_SUPPLEMENT

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

Color-matched rice powder pill

Chokeberry extract capsule, acute DIETARY_SUPPLEMENT

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

Chokeberry extract capsule (acute)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

Roy E. Jones Building

Storrs, Connecticut, 06269, United States

Location

Related Publications (2)

• 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.

  PMID: 27283706 RESULT

• 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.

  PMID: 28215316 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Bradley Bolling
• Organization: University of Wisconsin-Madison, Department of Food Science

bwbolling@wisc.edu

608-890-0212

Study Officials

• Bradley W Bolling, PhD

  University of Connecticut, University of Wisconsin-Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-04

Locations

US (1)