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Potential Health Effects of Aronia Intake

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ClinicalTrials.gov Identifier: NCT03405753
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Health Effects of Aronia Dietary Supplement: Aronia, washout and then placebo Dietary Supplement: Placebo, washout and then aronia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aroia Dietary Supplement: Aronia, 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 Supplement: Placebo, 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.

Placebo Comparator: Placebo Dietary Supplement: Aronia, 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 Supplement: Placebo, 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.




Primary Outcome Measures :
  1. Cholesterol [ Time Frame: 9 months ]
    HDL, LDL and total cholesterol in mmol/L


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405753


Contacts
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Contact: Maja DK Fedder, PhD +45 40434045 maja.doevling@gmail.com
Contact: Jens Fedder, Professor 26820368 jens.fedder@rsyd.dk

Locations
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Denmark
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Jens Fedder, MD, PhD         
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Jens Fedder, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03405753     History of Changes
Other Study ID Numbers: Lab.Reprod.Biol.-Aronia
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No