Potential Health Effects of Aronia Intake

NCT ID: NCT03405753

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Health Effects of Aronia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aroia

Group Type ACTIVE_COMPARATOR

Aronia, washout and then placebo

Intervention Type 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

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

Aronia, washout and then placebo

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Fedder

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 36615174 (View on PubMed)

Other Identifiers

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Lab.Reprod.Biol.-Aronia

Identifier Type: -

Identifier Source: org_study_id

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