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

NCT03824041 | Completed

• 1 other identifier: 18-8045H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Aging

Keywords

Polyphenols; Anthocyanins; Vascular function; Gut microbiome; Gut health; Berries

Outcome Measures

Primary Outcomes (1)

• Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption

  Determine the effects on RHI measured by EndoPAT

  Baseline and 6 weeks

Secondary Outcomes (10)

• Gut microbiota analysis

  Baseline and 6 weeks

• Blood pressure

  Baseline and 6 weeks

• Augmentation index

  Baseline and 6 weeks

• Gastrointestinal health

  Baseline and 6 weeks

• Pulse wave velocity

  Baseline and 6 weeks

Other Outcomes (3)

• Plasma polyphenol metabolites

  Baseline and 6 weeks

• Fecal polyphenol metabolites

  Baseline and 6 weeks

• Urine polyphenol metabolites

  Baseline and 6 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Formulation containing inert artificially colored maltodextrin, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg)

Dietary Supplement: Placebo

Aronia full spectrum - half dose

EXPERIMENTAL

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

Aronia full spectrum - full dose

EXPERIMENTAL

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

Interventions

Aronia full spectrum - half dose DIETARY_SUPPLEMENT

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Aronia full spectrum - half dose

Aronia full spectrum - full dose DIETARY_SUPPLEMENT

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Aronia full spectrum - full dose

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• Naturex-Dbs: collaborator

Study Sites (1)

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

Study Officials

• Sarah A Johnson, PhD, RDN

  Department of Food Science and Human Nutrition, Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 31, 2019
• Study Start: February 11, 2019
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)