Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Cholesterol
Study Overview
Brief Summary
Intervention cross-over study during which participants receive standardized amounts of aronia berry tablets or placebo for three months, then wash out for three months, then aronia tablets or placebo for three months. The potential health effects are investigated. Following parameters are measured before and after each period of tablet intake: 1) Blood pressure, 2) Lipid fractions, 3) Testosterone, 4) Phase II markers, 5) HbA1c, 6) HSCRP, 7) F2-isoprostanes, and 8) semen quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy men with total cholesterol between 5 and 7 mmol/L, who do not take medication
Exclusion Criteria
- •Chronic diseases and intake of medication or antioxidants
Arms & Interventions
Aroia
Intervention: Aronia, washout and then placebo (Dietary Supplement)
Aroia
Intervention: Placebo, washout and then aronia (Dietary Supplement)
Placebo
Intervention: Aronia, washout and then placebo (Dietary Supplement)
Placebo
Intervention: Placebo, washout and then aronia (Dietary Supplement)
Outcomes
Primary Outcomes
Cholesterol
Time Frame: 9 months
HDL, LDL and total cholesterol in mmol/L
Secondary Outcomes
- Phase II enzyme activity(9 months)
- Semen quality(9 months)
- Blood pressure(9 months)
- Isoprostanes(9 months)
- High Sensitivity C reactive protein(9 months)
Investigators
Jens Fedder
Professor
Odense University Hospital