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Completed

NCT Number: NCT03824041

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

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Aronia full spectrum - half dose

Dietary Supplement

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Aronia full spectrum - full dose

Dietary Supplement

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Placebo

Dietary Supplement

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Naturex-Dbs

Registry information

Official study title

Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Jul 3, 2023

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.

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