hardlopen geassocieerde aandoeningen NSAIDs related kidney injury running related kidney injury
Conditions
Interventions
Subjects will be randomly allocated into two groups and administered either two
capsules of MOF-VVPB or placebo twice a day for 14 days before the
participation in the half-marathon preceded by the
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter will be improved resistance to acute kidney damage as assessed by reduction of the neutrophil gelatinase-associated lipocalin (NGAL) concentration in urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints will include evaluation of: * kidney function assessed by urinary concentration of cystanin C, creatinine, urea, uric acid, Na+, Cl-, K+, glucose, beta-2microglobulin, albumin, albumin/creatinine ratio, urinary osmolality. * urinary inflammatory parameters such as tumor necrosis factor-alpha (TNF-*), interleukin (IL)-6, IL-8 and IL-18. * urinary parameters for oxidative stress such as malondialdehyde (MDA) and trolox equivalent antioxidant capacity (TEAC). * bilirubin, protein, erythrocytes, glucose, ketones, leukocytes, nitrite, pH, urobilinogen, specific gravity by urine dipstick. * urinary concentration of the extracellular vesicles. | — |
Countries
Netherlands
Outcome results
None listed