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Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults

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ClinicalTrials.gov Identifier: NCT03824041
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Naturex-Dbs
Information provided by (Responsible Party):
Colorado State University

Brief Summary:
Aging is the primary risk factor for cardiovascular disease (CVD) largely due to vascular endothelial dysfunction, a major initial step in the development of atherosclerosis. Endothelial dysfunction is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Interventions that improve endothelial dysfunction are important for improving endothelial function and reducing CVD risk in this high-risk population. Aronia melanocarpa, commonly known as aronia berries or chokeberries, are rich in polyphenols such as anthocyanins, proanthocyanidins, and phenolic acids. These compounds, and derivatives resulting from gut microbial and phase II metabolism, have been shown to attenuate oxidative stress and inflammation, and to improve endothelial function. Aronia berries and other berries have been shown in numerous studies to have diverse cardiometabolic health effects including modulation of endothelial function, arterial stiffness, blood pressure, oxidative stress, and inflammation. In addition, berries, dietary fiber, polyphenols have been shown to exert positive effects on the gut microbiota, which may mediate improvements in cardiovascular health. Recently, we have demonstrated that modulation of the gut microbiota is associated with improvements in vascular dysfunction. The primary goal of the currently proposed research is to assess the efficacy and dose-dependent response of an aronia full spectrum dietary supplement to improve endothelial function in middle-aged/older men and postmenopausal women. A secondary goal is to determine whether aronia full spectrum modulation of the gut microbiota is associated with improvements in endothelial function. Other functional and biochemical measures of cardiovascular health, oxidative stress, inflammation, and polyphenol metabolism will be assessed.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Aging Dietary Supplement: Aronia full spectrum - half dose Dietary Supplement: Aronia full spectrum - full dose Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg)
Dietary Supplement: Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Experimental: Aronia full spectrum - half dose
Formulation containing 50% Aronia full spectrum and 50% placebo, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg)
Dietary Supplement: Aronia full spectrum - half dose
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Experimental: Aronia full spectrum - full dose
Formulation of 100% Aronia full spectrum, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg)
Dietary Supplement: Aronia full spectrum - full dose
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)




Primary Outcome Measures :
  1. Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on RHI measured by EndoPAT


Secondary Outcome Measures :
  1. Gut microbiota analysis [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on stool sample microbial populations

  2. Blood pressure [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on brachial and aortic blood pressure measured by SphygmoCor

  3. Augmentation index [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on augmentation index measured by SphygmoCor

  4. Gastrointestinal health [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on gastrointestinal health using a validated questionnaire

  5. Pulse wave velocity [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on aortic arterial stiffness measured by SphygmoCor

  6. Blood lipids [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides)

  7. Blood hemoglobin A1c [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on Hemoglobin A1c

  8. Blood oxidized LDL [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on oxidized LDL

  9. Blood ICAM [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on ICAM

  10. Blood VCAM [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on VCAM


Other Outcome Measures:
  1. Plasma polyphenol metabolites [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on plasma polyphenol metabolites

  2. Fecal polyphenol metabolites [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on fecal polyphenol metabolites

  3. Urine polyphenol metabolites [ Time Frame: Baseline and 6 weeks ]
    Determine the effects on urine polyphenol metabolites



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and postmenopausal women (> 1 year from cessation of menstruation)
  • Aged 45-75 years
  • Baseline endothelial dysfunction (RHI ≤ 1.67)
  • Hemoglobin A1C ≤ 6.4%
  • Blood pressure < 129/80 mmHg
  • Total cholesterol < 240 mg/dL
  • LDL cholesterol < 190 mg/dL
  • Triglycerides < 350 mg/dLhttps://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U00036MD&ts=50&sid=S0008GBU&cx=gvt3fw
  • Body mass index ≥ 18.5 and < 30 kg/m2
  • Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
  • Are able to understand the nature of the study
  • Able and willing to give signed written informed consent
  • Signed informed consent form

Exclusion Criteria:

  • Individuals taking antihypertensive, lipid-lowering, and/or hormone replacement medications
  • Diagnosed hypertension, CVD, diabetes, metabolic syndrome, cancer, kidney, liver, pancreatic disease
  • Obese participants, defined as BMI superior or equal to 30
  • Neuropathy, thrombosis, or past arm trauma or surgery
  • > 3 days/wk vigorous exercise
  • Participating in a weight loss program
  • Weight change > 5% in the past 3 months
  • Current smokers or history of smoking in the last 12 months
  • Heavy drinkers (> 7 drinks/wk for women; >14 drinks/wk for men)
  • Antibiotic use at any point during the study or two months prior to enrollment
  • Allergies to aronia berries or other study materials
  • Unwillingness to maintain normal diet and/or physical activity pattern, or to discontinue use of dietary supplements for the duration of the study
  • Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824041


Contacts
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Contact: Allegra Vazquez, BS 970-491-0464 Allegra.Stroud@colostate.edu

Locations
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United States, Colorado
Department of Food Science and Human Nutrition, Colorado State University Recruiting
Fort Collins, Colorado, United States, 80523-1571
Contact: Sarah A Johnson, PhD, RDN    970-491-3807    Sarah.Johnson@colostate.edu   
Principal Investigator: Sarah A Johnson, PhD, RDN         
Sponsors and Collaborators
Colorado State University
Naturex-Dbs
Investigators
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Principal Investigator: Sarah A Johnson, PhD, RDN Department of Food Science and Human Nutrition, Colorado State University

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Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT03824041     History of Changes
Other Study ID Numbers: 18-8045H
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colorado State University:
Polyphenols
Anthocyanins
Vascular function
Gut microbiome
Gut health
Berries