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Potential Health Effects of Aronia Intake

O

Odense University Hospital

Status

Completed

Conditions

Health Effects of Aronia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03405753
Lab.Reprod.Biol.-Aronia

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

Male

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

109 participants in 2 patient groups, including a placebo group

Aroia
Active Comparator group
Treatment:
Dietary Supplement: Aronia, washout and then placebo
Dietary Supplement: Placebo, washout and then aronia
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Aronia, washout and then placebo
Dietary Supplement: Placebo, washout and then aronia

Trial contacts and locations

1

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Central trial contact

Jens Fedder, Professor; Maja DK Fedder, PhD

Data sourced from clinicaltrials.gov

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