- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824041
Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults
June 29, 2023 updated by: Colorado State University
Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1571
- Department of Food Science and Human Nutrition, Colorado State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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)
|
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)
|
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)
|
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut microbiota analysis
Time Frame: Baseline and 6 weeks
|
Determine the effects on stool sample microbial populations
|
Baseline and 6 weeks
|
Blood pressure
Time Frame: Baseline and 6 weeks
|
Determine the effects on brachial and aortic blood pressure measured by SphygmoCor
|
Baseline and 6 weeks
|
Augmentation index
Time Frame: Baseline and 6 weeks
|
Determine the effects on augmentation index measured by SphygmoCor
|
Baseline and 6 weeks
|
Gastrointestinal health
Time Frame: Baseline and 6 weeks
|
Determine the effects on gastrointestinal health using a validated questionnaire
|
Baseline and 6 weeks
|
Pulse wave velocity
Time Frame: Baseline and 6 weeks
|
Determine the effects on aortic arterial stiffness measured by SphygmoCor
|
Baseline and 6 weeks
|
Blood lipids
Time Frame: Baseline and 6 weeks
|
Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides)
|
Baseline and 6 weeks
|
Blood hemoglobin A1c
Time Frame: Baseline and 6 weeks
|
Determine the effects on Hemoglobin A1c
|
Baseline and 6 weeks
|
Blood oxidized LDL
Time Frame: Baseline and 6 weeks
|
Determine the effects on oxidized LDL
|
Baseline and 6 weeks
|
Blood ICAM
Time Frame: Baseline and 6 weeks
|
Determine the effects on ICAM
|
Baseline and 6 weeks
|
Blood VCAM
Time Frame: Baseline and 6 weeks
|
Determine the effects on VCAM
|
Baseline and 6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma polyphenol metabolites
Time Frame: Baseline and 6 weeks
|
Determine the effects on plasma polyphenol metabolites
|
Baseline and 6 weeks
|
Fecal polyphenol metabolites
Time Frame: Baseline and 6 weeks
|
Determine the effects on fecal polyphenol metabolites
|
Baseline and 6 weeks
|
Urine polyphenol metabolites
Time Frame: Baseline and 6 weeks
|
Determine the effects on urine polyphenol metabolites
|
Baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah A Johnson, PhD, RDN, Department of Food Science and Human Nutrition, Colorado State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
July 26, 2021
Study Completion (Actual)
July 26, 2021
Study Registration Dates
First Submitted
January 10, 2019
First Submitted That Met QC Criteria
January 28, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 18-8045H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States