- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405753
Potential Health Effects of Aronia Intake
November 1, 2023 updated by: Jens Fedder, Odense University Hospital
Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maja DK Fedder, PhD
- Phone Number: +45 40434045
- Email: maja.doevling@gmail.com
Study Contact Backup
- Name: Jens Fedder, Professor
- Phone Number: 26820368
- Email: jens.fedder@rsyd.dk
Study Locations
-
-
-
Odense, Denmark, DK-5000
- Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
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.
|
Active Comparator: Aroia
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cholesterol
Time Frame: 9 months
|
HDL, LDL and total cholesterol in mmol/L
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase II enzyme activity
Time Frame: 9 months
|
Glutathion in U/mL
|
9 months
|
Phase II enzyme activity
Time Frame: 9 months
|
Superoxid dismutase (SOD) in U/mL
|
9 months
|
Phase II enzyme activity
Time Frame: 9 months
|
Catalase (CAT) in U/mL
|
9 months
|
Isoprostanes
Time Frame: 9 months
|
Peroxidation of fatty acids measured in U/mL
|
9 months
|
Semen quality
Time Frame: 9 months
|
Sperm count in million/mL
|
9 months
|
Semen quality
Time Frame: 9 months
|
Motility in percent
|
9 months
|
Semen quality
Time Frame: 9 months
|
DNA fragmentation in percent
|
9 months
|
Blood pressure
Time Frame: 9 months
|
Systolic and diastolic blood pressure in mmHg
|
9 months
|
High Sensitivity C reactive protein
Time Frame: 9 months
|
Acute phase reactant in mg/L
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
January 5, 2018
First Submitted That Met QC Criteria
January 12, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Lab.Reprod.Biol.-Aronia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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