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

NCT ID: NCT03824041

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2021-07-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

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)

Group Type: EXPERIMENTAL

Aronia full spectrum - half dose

Intervention Type: DIETARY_SUPPLEMENT

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

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)

Group Type: EXPERIMENTAL

Aronia full spectrum - full dose

Intervention Type: DIETARY_SUPPLEMENT

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Interventions

Aronia full spectrum - half dose

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Intervention Type: DIETARY_SUPPLEMENT

Aronia full spectrum - full dose

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naturex-Dbs

INDUSTRY

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah A Johnson, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Department of Food Science and Human Nutrition, Colorado State University

Locations

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

18-8045H

Identifier Type: -

Identifier Source: org_study_id