In the present study we aim to assess the efficacy of a 14-days intervention with monomeric and oligomeric flavanols from Vitis vinifera seeds and Pinus pinaster bark (MOF-VVPB) which are the active principle in Masquelier*s® French Pine Bark…
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
hardlopen geassocieerde aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Running is associated with a healthy life style and improved quality of life.
At the same time, participation in vigorous exercise such as marathon can be
accompanied by significant shift in the health biomarkers and development of
transient kidney damage. This risk may be potentiated by intake of
nonsteroidal anti-inflammatory drugs (NSAIDs). It has been shown that
development of oxidative stress, endothelial dysfunction and pro-inflammatory
state play an important role in the pathogenesis of acute kidney damage
associated with the endurance running. Monomeric and oligomeric flavanols (MOF)
are well characterized for their antioxidant, anti-inflammatory effects as well
as pleiotropic beneficial actions on the vascular function. However, the
potential protective influence of MOF on the kidney function in the
half-marathon runners taking a single low-dose of ibuprofen has not been
investigated.
Study objective
In the present study we aim to assess the efficacy of a 14-days intervention
with monomeric and oligomeric flavanols from Vitis vinifera seeds and Pinus
pinaster bark (MOF-VVPB) which are the active principle in Masquelier*s® French
Pine Bark Extract with Original OPCs on the parameters of renal injury, urinary
biomarkers of inflammation and oxidative stress in recreational runners who run
a half-marathon and take a single low-dose dose of ibuprofen prior to the
start.
Study design
Double-blind, randomized, placebo-controlled, pilot study.
Intervention
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 intake of a single low dose
of ibuprofen.
Study burden and risks
The risk associated with the participation in this study will be related to
intake of the investigational product MOF-VVPB, participation in the
half-marathon and use of a single low dose of ibuprofen. Oral consumption
MOF-VVPB is generally well tolerated and has not been associated with
significant side effects except mild gastrointestinal discomfort in some of the
previous studies. At the same time, it may offer protection against the kidney
injury due to vasoprotective, antioxidant and anti-inflammatory effects.
Participation in the half-marathon carries risk of exercise-induced injuries,
dehydration, electrolyte imbalance, acute kidney injury and, in rare cases,
myocardial infarction and exercise-related death. Intake of NSAIDs to prevent
exercise related pain and improve performance may increase the risk of acute
kidney injury and gastrointestinal dysfunction in runners. But there is no
clear evidence that administration of a single low-dose ibuprofen and running
21.1 km may exert significant hazardous effects on the kidney function.
The results of this study will provide information whether the intake of the
monomeric and oligomeric flavanols can reduce the risk of kidney damage,
improve resistance to oxidative stress and excessive inflammatory response
associated with running half-marathon and preventive use of NSAIDs. This will
be important for the design of the future trials aiming to develop
recommendations on nutrition and use of dietary supplements in physically
active individuals. Moreover, the study will improve our understanding of the
risk imposed by preventive use of low-dose ibuprofen and running half-marathon
distance. In the longer perspective, this research will contribute to increase
in the overall safety of the commonly practiced life style - recreational
running.
The procedures involved in this study will include interview, assessment of the
vital signs, completion of the study related questionnaires and collection of
the urine samples before and after use of low-dose ibuprofen followed by the
half-marathon. No other procedures including invasive ones will be involved.
Runners will receive a unsubstantial financial reward as a benefit for the
participation in this study.
Deken van Oppensingel 23
Venlo 5911 AA
NL
Deken van Oppensingel 23
Venlo 5911 AA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65544.072.18 |