Endothelial DysfunctionNCT03824041
Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults
A study testing Aronia full spectrum - half dose and Aronia full spectrum - full dose in people with Endothelial Dysfunction and Aging, run by Colorado State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Aging
- What is being tested?
- Aronia full spectrum - half dose and Aronia full spectrum - full dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
Official title: 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.
- Conditions
- Endothelial Dysfunction, Aging
- Being tested
- Aronia full spectrum - half dose, Aronia full spectrum - full dose, Placebo
- Keywords
- Polyphenols, Anthocyanins, Vascular function, Gut microbiome, Gut health, Berries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aronia full spectrum - half doseDietary supplement
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
Aronia full spectrum - full doseDietary supplement
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
PlaceboDietary supplement
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Formulation containing inert artificially colored maltodextrin, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) Receives: 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) Receives: 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) Receives: Dietary Supplement: Aronia full spectrum - full dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption
Determine the effects on RHI measured by EndoPAT
Measured: Baseline and 6 weeks
Secondary outcomes (10)
Gut microbiota analysis
Determine the effects on stool sample microbial populations
Measured: Baseline and 6 weeks
Blood pressure
Determine the effects on brachial and aortic blood pressure measured by SphygmoCor
Measured: Baseline and 6 weeks
Augmentation index
Determine the effects on augmentation index measured by SphygmoCor
Measured: Baseline and 6 weeks
Gastrointestinal health
Determine the effects on gastrointestinal health using a validated questionnaire
Measured: Baseline and 6 weeks
Pulse wave velocity
Determine the effects on aortic arterial stiffness measured by SphygmoCor
Measured: Baseline and 6 weeks
Blood lipids
Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides)
Measured: Baseline and 6 weeks
Blood hemoglobin A1c
Determine the effects on Hemoglobin A1c
Measured: Baseline and 6 weeks
Blood oxidized LDL
Determine the effects on oxidized LDL
Measured: Baseline and 6 weeks
Blood ICAM
Determine the effects on ICAM
Measured: Baseline and 6 weeks
Blood VCAM
Determine the effects on VCAM
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start11 Feb 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex-Dbs
- Responsible party
- Sponsor
- Investigators
- Sarah A Johnson, PhD, RDN, Principal investigator, Department of Food Science and Human Nutrition, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824041
- Sponsor's protocol ID
- 18-8045H
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults
- ClinicalTrials.gov ID
- NCT03824041
- Acronym / sponsor ID
- 18-8045H
- Conditions
- Endothelial Dysfunction, Aging
- Keywords
- Polyphenols, Anthocyanins, Vascular function, Gut microbiome, Gut health, Berries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Naturex-Dbs
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFormulation containing inert artificially colored maltodextrin, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
| Aronia full spectrum - half dose | Experimental | Dietary Supplement: Aronia full spectrum - half doseFormulation containing 50% Aronia full spectrum and 50% placebo, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
| Aronia full spectrum - full dose | Experimental | Dietary Supplement: Aronia full spectrum - full doseFormulation of 100% Aronia full spectrum, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aronia full spectrum - half dosePowdered whole fruit obtained from aronia berries (Aronia melanocarpa) | Dietary supplement | Aronia full spectrum - half dose |
| Aronia full spectrum - full dosePowdered whole fruit obtained from aronia berries (Aronia melanocarpa) | Dietary supplement | Aronia full spectrum - full dose |
| PlaceboIdentical formulation as the treatment consisting of colored maltodextrin using artificial colors. | Dietary supplement | Placebo |
Primary outcome
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
10 secondary outcomes
Gut microbiota analysis
Time frame: Baseline and 6 weeks
Blood pressure
Time frame: Baseline and 6 weeks
Augmentation index
Time frame: Baseline and 6 weeks
Gastrointestinal health
Time frame: Baseline and 6 weeks
Pulse wave velocity
Time frame: Baseline and 6 weeks
Blood lipids
Time frame: Baseline and 6 weeks
Blood hemoglobin A1c
Time frame: Baseline and 6 weeks
Blood oxidized LDL
Time frame: Baseline and 6 weeks
Blood ICAM
Time frame: Baseline and 6 weeks
Blood VCAM
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Endothelial Dysfunction
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Johnson, PhD, RDN principal investigator
Department of Food Science and Human Nutrition, Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aronia full spectrum - half dose and Aronia full spectrum - full dose in people with Endothelial Dysfunction and Aging, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.