Potential Health Effects of Aronia Intake

Health Effects of Aronia Clinical Trial

Official title:

Effects of Aronia Berry on Oxidative Stress, Cholesterol, Blood Pressure and Semen Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405753
• Other study ID #: Lab.Reprod.Biol.-Aronia
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Effects of Aronia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol	HDL, LDL and total cholesterol in mmol/L	9 months
Secondary	Phase II enzyme activity	Glutathion in U/mL	9 months
Secondary	Phase II enzyme activity	Superoxid dismutase (SOD) in U/mL	9 months
Secondary	Phase II enzyme activity	Catalase (CAT) in U/mL	9 months
Secondary	Isoprostanes	Peroxidation of fatty acids measured in U/mL	9 months
Secondary	Semen quality	Sperm count in million/mL	9 months
Secondary	Semen quality	Motility in percent	9 months
Secondary	Semen quality	DNA fragmentation in percent	9 months
Secondary	Blood pressure	Systolic and diastolic blood pressure in mmHg	9 months
Secondary	High Sensitivity C reactive protein	Acute phase reactant in mg/L	9 months