Potential Health Effects of Aronia Intake

Not Applicable

Completed

• Conditions: Health Effects of Aronia

• Registration Number: NCT03405753
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-23
• Study Start: 2018-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cholesterol	9 months	HDL, LDL and total cholesterol in mmol/L

Secondary Outcome Measures

Name	Time	Method
Semen quality	9 months	DNA fragmentation in percent
Blood pressure	9 months	Systolic and diastolic blood pressure in mmHg
Phase II enzyme activity	9 months	Catalase (CAT) in U/mL
Isoprostanes	9 months	Peroxidation of fatty acids measured in U/mL
High Sensitivity C reactive protein	9 months	Acute phase reactant in mg/L

Trial Locations

Locations (1)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital; 🇩🇰 Odense, Denmark