Status:
COMPLETED
Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
Naturex-Dbs
Conditions:
Endothelial Dysfunction
Aging
Eligibility:
All Genders
45-75 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03824041
Start Date
February 11 2019
End Date
July 26 2021
Last Update
July 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, United States, 80523-1571