Health Effects of AroniaNCT03405753

Potential Health Effects of Aronia Intake

A study of Health Effects of Aronia, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Health Effects of Aronia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: 1 siteDenmark
Study dates: 1 Feb 2018to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy men with total cholesterol between 5 and 7 mmol/L, who do not take medication

Who cannot join

Chronic diseases and intake of medication or antioxidants

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, DK-5000

Other trials in Denmark

About this study

Official title: 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.

Conditions: Health Effects of Aronia
Being tested: Aronia, washout and then placebo, Placebo, washout and then aronia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aronia, washout and then placeboDietary 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 aroniaDietary 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.

Study groups in NCT03405753
Study group	Role	What they receive
Aroia	Active comparator	Not described Receives: Dietary Supplement: Aronia, washout and then placebo; Dietary Supplement: Placebo, washout and then aronia
Placebo	Placebo comparator	Not described Receives: Dietary Supplement: Aronia, washout and then placebo; Dietary Supplement: Placebo, washout and then aronia

What is being measured

The primary outcome is the main question the study is designed to answer.

Cholesterol
HDL, LDL and total cholesterol in mmol/L
Measured: 9 months

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201831 Dec 2022

First posted23 Jan 2018
Study start1 Feb 2018
Primary completion31 Dec 2021
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Health Effects of AroniaStudies of the same condition, open and under way.
More trials run by Odense University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03405753
Sponsor's protocol ID: Lab.Reprod.Biol.-Aronia
Status last verified: Nov 2023
First submitted: 5 Jan 2018
Last updated: 3 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sangild J, Faldborg A, Schousboe C, Fedder MDK, Christensen LP, Lausdahl AK, Arnspang EC, Gregersen S, Jakobsen HB, Knudsen UB, Fedder J. Effects of Chokeberries (Aronia spp.) on Cytoprotective and Cardiometabolic Markers and Semen Quality in 109 Mildly Hypercholesterolemic Danish Men: A Prospective, Double-Blinded, Randomized, Crossover Trial. J Clin Med. 2023 Jan 3;12(1):373. doi: 10.3390/jcm12010373.
PubMed 36615174

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality
ClinicalTrials.gov ID: NCT03405753
Acronym / sponsor ID: Lab.Reprod.Biol.-Aronia
Conditions: Health Effects of Aronia
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Odense University HospitalUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 23 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aroia	Active comparator	Dietary Supplement: Aronia, washout and then placebo, Dietary Supplement: Placebo, washout and then aronia
Placebo	Placebo comparator	Dietary Supplement: Aronia, washout and then placebo, Dietary Supplement: Placebo, washout and then aronia

Who may qualify

Ages: 25 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy men with total cholesterol between 5 and 7 mmol/L, who do not take medication

Key exclusion criteria (1 listed)

Chronic diseases and intake of medication or antioxidants

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aronia, washout and then placeboThree 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	Aroia, Placebo
Placebo, washout and then aroniaThree 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.	Dietary supplement	Aroia, Placebo

Primary outcome

Cholesterol
Time frame: 9 months
HDL, LDL and total cholesterol in mmol/L

9 secondary outcomes

Phase II enzyme activity
Time frame: 9 months
Phase II enzyme activity
Time frame: 9 months
Phase II enzyme activity
Time frame: 9 months
Isoprostanes
Time frame: 9 months
Semen quality
Time frame: 9 months
Semen quality
Time frame: 9 months
Semen quality
Time frame: 9 months
Blood pressure
Time frame: 9 months
High Sensitivity C reactive protein
Time frame: 9 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Background: PubMed 36615174Sangild J, Faldborg A, Schousboe C, Fedder MDK, Christensen LP, Lausdahl AK, Arnspang EC, Gregersen S, Jakobsen HB, Knudsen UB, Fedder J. Effects of Chokeberries (Aronia spp.) on Cytoprotective and Cardiometabolic Markers and Semen Quality in 109 Mildly Hypercholesterolemic Danish Men: A Prospective, Double-Blinded, Randomized, Crossover Trial. J Clin Med. 2023 Jan 3;12(1):373. doi: 10.3390/jcm12010373.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Health Effects of Aronia, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cholesterol (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03405753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.