Health Effects of Aronia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAronia, washout and then placebo
Three tablets three times à day for three months then washout for three months, then three placebo tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.
DIETARY_SUPPLEMENTPlacebo, washout and then aronia
Three tablets three times à day for three months, then washout for three months, then three aronia tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | 9 months | HDL, LDL and total cholesterol in mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II enzyme activity | 9 months | Glutathion in U/mL |
| Isoprostanes | 9 months | Peroxidation of fatty acids measured in U/mL |
| Semen quality | 9 months | Sperm count in million/mL |
| Blood pressure | 9 months | Systolic and diastolic blood pressure in mmHg |
| High Sensitivity C reactive protein | 9 months | Acute phase reactant in mg/L |
Countries
Denmark
Outcome results
None listed