The protective effect of Masquelier*s® French Pine Bark Extract with Original OPC in half-marathon runners using a single low dose of ibuprofe

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Signed informed consent prior to initiation of any study related procedures.
2. Healthy male and female recreational runners above 18 years of age.
3. Presence of at least 2 years of running experience.
4. Self-reported use of pain killers before/during at least two previous running events.
5. Normal constant eating habits during at least 3 months prior to inclusion into the study.

Exclusion Criteria

1. Participation in another marathon or half-marathon within last 4 weeks prior to inclusion into this study.
2. Regular use of NSAIDs within 4 weeks prior to inclusion into this study.
3. Donation of blood within 8 weeks prior to the inclusion into this study.
4. Use of drugs that lower blood pressure and impair renal autoregulation (e.g. angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, diuretics), anabolic steroids or other stimulants or drugs largely influencing glucose and lipid metabolism within 4 weeks prior to inclusion into this study.
5. History of hypothyroidism, chronic kidney or/and liver disorders, coronary artery disease, malignant hypertension, seizures.
6. Active smoking within the last 6 months prior to inclusion into this study.
7. Viral or bacterial infection requiring use of antibiotics, laxatives and anti-diarrhoeal drugs within 4 weeks prior to inclusion into this study.
8. Use of dietary supplements with potential effects on antioxidant or inflammatory status or with potential renoprotective effects within 4 weeks prior to inclusion into this study.
9. Vegetarian or vegan life-style.
10. Excessive alcohol consumption (> 28 consumptions approx. 250 g alcohol per week).
11. Use of a medically prescribed or slimming diet.
12. Any major running injuries over past 3 months prior to the baseline assessments.
13. Participation in a clinical trial within 4 weeks prior to inclusion into this study.
14. Pregnancy and/or breastfeeding.
15. Psychotic, addictive or other mental disorder limiting the ability to provide informed consent or to comply with the study requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter will be improved resistance to acute kidney damage as<br /><br>assessed by reduction of the neutrophil gelatinase-associated lipocalin (NGAL)<br /><br>concentration in urine. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study endpoints will include evaluation of:<br /><br>* kidney function assessed by urinary concentration of cystanin C, creatinine,<br /><br>urea, uric acid, Na+, Cl-, K+, glucose, beta-2microglobulin, albumin,<br /><br>albumin/creatinine ratio, urinary osmolality.<br /><br>* urinary inflammatory parameters such as tumor necrosis factor-alpha (TNF-),<br /><br>interleukin (IL)-6, IL-8 and IL-18.<br /><br> urinary parameters for oxidative stress such as malondialdehyde (MDA) and<br /><br>trolox equivalent antioxidant capacity (TEAC).<br /><br>* bilirubin, protein, erythrocytes, glucose, ketones, leukocytes, nitrite, pH,<br /><br>urobilinogen, specific gravity by urine dipstick.<br /><br>* urinary concentration of the extracellular vesicles.</p><br>