Potential Health Effects of Aronia Intake

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality

Conditions
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Health Effects of Aronia

Intervention / Treatment
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* Dietary Supplement: Aronia, washout and then placebo
* Dietary Supplement: Placebo, washout and then aronia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aroia<br> | Dietary Supplement: Aronia, washout and then placebo<br>* 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.<br>Dietary Supplement: Placebo, washout and then aronia<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Aronia, washout and then placebo<br>* 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.<br>Dietary Supplement: Placebo, washout and then aronia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol | HDL, LDL and total cholesterol in mmol/L | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II enzyme activity | Glutathion in U/mL | 9 months | 
| Phase II enzyme activity | Superoxid dismutase (SOD) in U/mL | 9 months | 
| Phase II enzyme activity | Catalase (CAT) in U/mL | 9 months | 
| Isoprostanes | Peroxidation of fatty acids measured in U/mL | 9 months | 
| Semen quality | Sperm count in million/mL | 9 months | 
| Semen quality | Motility in percent | 9 months | 
| Semen quality | DNA fragmentation in percent | 9 months | 
| Blood pressure | Systolic and diastolic blood pressure in mmHg | 9 months | 
| High Sensitivity C reactive protein | Acute phase reactant in mg/L | 9 months |