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CompletedNCT03405753Updated Nov 3, 2023

Potential Health Effects of Aronia Intake

An interventional study of Aronia, washout and then placebo and Placebo, washout and then aronia in Health Effects of Aronia, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to male participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Health Effects of Aronia
03

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic diseases and intake of medication or antioxidants
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
109 participants (actual)

Study arms

  • Active comparator
    Aroia

    Dietary Supplement: Aronia, washout and then placebo · Dietary Supplement: Placebo, washout and then aronia

  • Placebo comparator
    Placebo

    Dietary Supplement: Aronia, washout and then placebo · Dietary Supplement: Placebo, washout and then aronia

Interventions

  • Dietary supplementAronia, 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 supplementPlacebo, 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.

05

What researchers measure

Primary outcomes

  1. Cholesterol

    HDL, LDL and total cholesterol in mmol/L

    Time frame: 9 months

Secondary outcomes

  1. Phase II enzyme activity

    Glutathion in U/mL

    Time frame: 9 months

  2. Phase II enzyme activity

    Superoxid dismutase (SOD) in U/mL

    Time frame: 9 months

  3. Phase II enzyme activity

    Catalase (CAT) in U/mL

    Time frame: 9 months

  4. Isoprostanes

    Peroxidation of fatty acids measured in U/mL

    Time frame: 9 months

  5. Semen quality

    Sperm count in million/mL

    Time frame: 9 months

  6. Semen quality

    Motility in percent

    Time frame: 9 months

  7. Semen quality

    DNA fragmentation in percent

    Time frame: 9 months

  8. Blood pressure

    Systolic and diastolic blood pressure in mmHg

    Time frame: 9 months

  9. High Sensitivity C reactive protein

    Acute phase reactant in mg/L

    Time frame: 9 months

06

Study locations

1 site
  • Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
    Odense, DK-5000, Denmark
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03405753
Lead sponsor
Odense University Hospital
Responsible party
Jens Fedder (Professor, Odense University Hospital) — Principal investigator
First posted
Jan 23, 2018
Start date
Feb 1, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022
Last update
Nov 3, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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