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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824041
• Other study ID #: 18-8045H
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: July 26, 2021

Study information

• Verified date: June 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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&s id=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

Related Conditions & MeSH terms

• Aging
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Aronia full spectrum - half dose
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
• Aronia full spectrum - full dose
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
• Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Locations

Country	Name	City	State
United States	Department of Food Science and Human Nutrition, Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	Naturex-Dbs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma polyphenol metabolites	Determine the effects on plasma polyphenol metabolites	Baseline and 6 weeks
Other	Fecal polyphenol metabolites	Determine the effects on fecal polyphenol metabolites	Baseline and 6 weeks
Other	Urine polyphenol metabolites	Determine the effects on urine polyphenol metabolites	Baseline and 6 weeks
Primary	Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption	Determine the effects on RHI measured by EndoPAT	Baseline and 6 weeks
Secondary	Gut microbiota analysis	Determine the effects on stool sample microbial populations	Baseline and 6 weeks
Secondary	Blood pressure	Determine the effects on brachial and aortic blood pressure measured by SphygmoCor	Baseline and 6 weeks
Secondary	Augmentation index	Determine the effects on augmentation index measured by SphygmoCor	Baseline and 6 weeks
Secondary	Gastrointestinal health	Determine the effects on gastrointestinal health using a validated questionnaire	Baseline and 6 weeks
Secondary	Pulse wave velocity	Determine the effects on aortic arterial stiffness measured by SphygmoCor	Baseline and 6 weeks
Secondary	Blood lipids	Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides)	Baseline and 6 weeks
Secondary	Blood hemoglobin A1c	Determine the effects on Hemoglobin A1c	Baseline and 6 weeks
Secondary	Blood oxidized LDL	Determine the effects on oxidized LDL	Baseline and 6 weeks
Secondary	Blood ICAM	Determine the effects on ICAM	Baseline and 6 weeks
Secondary	Blood VCAM	Determine the effects on VCAM	Baseline and 6 weeks