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OpenTrials
Completed

NCT Number: NCT03405753

Potential Health Effects of Aronia Intake

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.

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Key information

Conditions

Health Effects of Aronia

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Odense, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aronia, washout and then placebo

Dietary Supplement

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.

Placebo, washout and then aronia

Dietary Supplement

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.

Primary outcomes

  1. Cholesterol

    Time frame: 9 months

    HDL, LDL and total cholesterol in mmol/L

Secondary outcomes

  1. Phase II enzyme activity

    Time frame: 9 months

    Glutathion in U/mL

  2. Phase II enzyme activity

    Time frame: 9 months

    Superoxid dismutase (SOD) in U/mL

  3. Phase II enzyme activity

    Time frame: 9 months

    Catalase (CAT) in U/mL

  4. Isoprostanes

    Time frame: 9 months

    Peroxidation of fatty acids measured in U/mL

  5. Semen quality

    Time frame: 9 months

    Sperm count in million/mL

  6. Semen quality

    Time frame: 9 months

    Motility in percent

  7. Semen quality

    Time frame: 9 months

    DNA fragmentation in percent

  8. Blood pressure

    Time frame: 9 months

    Systolic and diastolic blood pressure in mmHg

  9. High Sensitivity C reactive protein

    Time frame: 9 months

    Acute phase reactant in mg/L

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 23, 2018
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.