Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01831492 |
| Other study ID # |
25-217 ex 12/13 |
| Secondary ID |
PSS |
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 9, 2013 |
| Last updated |
February 9, 2016 |
| Start date |
April 2013 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
February 2016 |
| Source |
Green Beat |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Austria: Ethikkommission |
| Study type |
Interventional
|
Clinical Trial Summary
Purpose:
This study investigates the effects of dietary zeolite + dolomite on performance,
exercise-induced acidosis, oxidative stress, inflammation and intestinal barrier dysfunction
in trained people.
Hypotheses (H1):
Zeolite + dolomite increase performance in an ergometer step test Zeolite + dolomite reduce
exercise-induced acidosis Zeolite + dolomite reduce oxidative stress Zeolite + dolomite
reduce inflammation Zeolite + dolomite improve intestinal barrier dysfunction
Description:
The application of adequate nutraceuticals for sporty people´s performance and health
becomes more and more interesting for athletes and their carers. There are also great
opportunities for product providers in this field to act commercially profitable.
Beside the main goal - to achieve improved performance - modern sport nutraceuticals should
support immunity of athletes in all corners of health. One of the most interesting
approaches in this field is to promote performance and health via dietary zeolites. Zeolites
are synthetic microporous crystals containing AIO4 and SiO4 tetrahedrons. It is hypothesized
that in human body these silicates act as gut-located adsorbents of chymus molecules or as
ion-exchangers, catalysts, detergent builders or antidiarrheic agents (1, 2, 3, 4). These -
mainly physical - effects of dietary used zeolite might also influence the chief issues of
modern sport nutrition: performance, acidosis, oxidative stress, inflammation,
gastrointestinal complaints and associated impacts on immunity and health.
The investigators hypothesize that the physical effects of zeolite affect the metabolism in
the gut and exert systemic physiological/biochemical benefits in regard to human´s exercise
performance, redox biology, inflammatory processes, acid-base balance, and even intestinal
barrier integrity/function. All these postulated benefits would have tremendous impact on
sports performance. However, up to date no clinical study is reported on PubMed that
addresses these chief aims of sport nutrition in the context of zeolite supplementation.
GOALS
This protocol describes a study that investigates the effects of dietary zeolite + dolomite
(Product name: "PANACEO SPORT") on performance, exercise-induced (acute or chronically)
acidosis, oxidative stress, inflammation and intestinal barrier dysfunction. This is a
randomized, placebo-controlled, double-blinded, parallel-grouped study design. In detail,
the investigators want to assess the effects of dietary zeolite + dolomite (the commercially
available product "PANACEO-SPORT") on:
1. Aerobic performance capability and maximum oxygen uptake (primary outcome)
2. Lactate kinetics and maximum lactate concentrations in blood (secondary outcome)
3. Oxidative stress (OS)/redox biology and inflammation (tertiary outcome)
4. Intestinal barrier integrity and endotoxemia (quaternary outcome) The investigators
hypothesize that the intake of the product will beneficially influence outcomes 1-4
(H1-hypotheses 1-4: "Supplementation will influence...").
MERITS of this study Data of this project will provide knowledge regarding the effects
of zeolite and dolomite on aerobic performance, lactate kinetics, redox biology,
inflammation and integrity of intestinal barrier. Results will help us to identify how
to support chronically exercising people to optimize their performance and health.
METHODS
- Subjects: 56 healthy men, non-professional but homogeneously trained
(>50ml/kg/min) triathletes and/or cyclists and/or dual athletes, non-smokers,
20-50 yrs, comparable body fat content (<20%) and psycho-physical stress profile,
non-medicated, preventive
medical check-up and actual proofed eligibility to conduct sports, pre-selection via
telephone interviews.
- Design: randomized, double-blinded, placebo-controlled, 2-arm parallel-group
design. One arm is the placebo group, the second arm receives zeolite + dolomite
("PANACEO-SPORT"). After a wash-out of 4wk from any food supplements, also from
specific dietetic and drug treatment, a period of 12wk with supplementation or
placebo follows. At 0wk, 4wk and 12wk we conduct performance diagnostics. At 0wk
and 12wk we collect blood and stool.
- Treatment: Subjects receive 6 capsules per day of zeolite + dolomite
("PANACEO-SPORT") or placebo capsules with identical appearance. Subjects will be
instructed to consume 3 capsules with the first meal of the day and 3 capsules
with the last meal of the day. We recommend to dispense one box per subject and to
produce 60 boxes containing 600 capsules each (lasting for 100 days in maximum).
- Surrogate markers/parameters from blood and stool are measured at 0wk and 12wk.
Blood samples are collected before the exercise tests. The subjects will bring the
samples of their last stool before the exercise tests (at weeks 0 and 12) directly
to the exercise physiology laboratory. For blood lactate - in the context of
performance diagnostics at weeks 0, 4 and 12 - we collect capillary earlobe blood
before, during and until 30 minutes post exercise.
- Subjects monitor stool appearance via Bristol stool scale/protocol. This is
conducted the week before the first exercise test and in the 12th week.
- Quality of life survey is conducted in the running in period (stress profile)
- The week before the exercise test it is necessary to adhere to a 4-day diet plan
(the last 4 days before the test) and to conduct a 7-day food recording. These
sanctions are necessary to match carbohydrate, fat, protein and micronutrient
intake and to exclude diet-associated biased lactate kinetics.
MARKERS/PARAMETERS
• Performance diagnostics: maximum performance in watt (Pmax), maximum oxygen uptake
capacity (VO2max), CO2 exhalation, CO2/O2 ratio, lactate kinetics, maximum lactate,
lactate turnpoint 1 (LTP1), lactate turnpoint 2 (LTP2) and anaerobic threshold (ANS),
respiratory quotient, EKG for cardiocirculatory innocuousness.
- Minerals (serum/plasma) and standard blood chemistry: Mg, Ca, Fe, K, Na, Al, Si,
P, Cl, ALT, AST, creatinine, ferritin, transferrin, uric acid, vitamin C, free
testosterone, SHBG (testosterone transporter), FAI (= free androgen index =
Testosterone x 100/SHBG).
- OS/redox biology (serum/plasma): carbonyl proteins (CP), F2-isoprostanes, total
oxidation status (TOS), proteinogenic antioxidant capacity (PAOC),
non-proteinogenic antioxidant capacity (NPAOC), DNA strand breaks, glutathione
peroxidase 3.
- Inflammation/immunity (blood/serum/plasma): TNF-alpha, IL-6, IL-8, IL-10, IL-22.
- Intestinal barrier integrity and endotoxemia: Zonulin (stool), claudin1 and
claudin2 (stool), lipopolysaccharides (blood), toll-like receptors (TLR2 and TLR4
from blood), gut profile "basis" (kind and number of colonies, Calprotectin,
α1-antitrypsin etc).
- Body fat determination and distribution via lipometry (non-invasive) at weeks 0
and 14.
BLOOD SAMPLING
• Week 0: At rest, after 4wk wash-out and before 1st performance diagnostics
- Week 12: At rest, after 12wk before 3rd performance diagnostics
- Capillary blood from earlobe to determine lactate is drawn before, during and
after exercise at weeks 0, 4 and 12: at each step of exercise and 3, 6, 9, 12, 15,
20 and 30 min post exercise to evaluated recovery lactate kinetics.
STOOL SAMPLING
- Week 0: At rest, after 4 wk wash-out and before 1st performance diagnostics
- Week 12: At rest, before 3rd performance diagnostics
PROTOCOLS/QUESTIONNAIRES
• Stool protocol is conducted the week before 1st and 3rd performance testing
• Food habits are documented by food recording and the diet plan the last week prior to
each exercise test, at weeks 0, 4 and 12
- Exercise and trainings habits are evaluated by the sport scientist via interview
before each performance testing
- Psycho-social well-being and stress perception are evaluated with the "Quality of
Life-BREF" questionnaire (SF36) before the 1st and 3rd performance testing
PERFORMANCE DIAGNOSTIC (PD) PD is a cycle-steptest-ergometry to performance/watt
maximum, lactate maximum and VO2max.. After 3 min rest on the cycle ergometer, subjects
start exercise with another 3 min warm up at 60 watt. Then they increase exercise
intensity by 15 watt per min (with constant 80 rpm) until exhaustion/VO2max. After
reaching exhaustion/VO2max, candidates continue to perform at low intensity (at 30% of
Pmax) for further 30 minutes to observe recovery lactate kinetics.
All tests are supervised by a physician and a sport scientist. Before each test,
volunteers are also checked by the physician.
PD is conducted at:
• Week 0: 1st performance diagnostics = last selection of candidates (detailed medical
check, standard blood chemistry panel)
• Week 4: 2nd performance diagnostics
• Week 12: 3rd and last performance diagnostics
LIPOMETRY
- Week 0: At rest, after 4wk wash-out and before 1st performance diagnostics
- Week 12: At rest, after 12wk of supplementation and before 3rd performance
diagnostics
SAMPLE SIZE CALCULATION & RANDOMIZATION Sample size calculation is based on the
expectation of an 8% increase in performance capability (in watt) after 4 weeks of
treatment with zeolite + dolomite ("PANACEO-SPORT"), compared to placebo (no change).
The investigators expect an average Pmax of 345 watt in this trained cohort, a standard
deviation of 10%, and chose a power of 80% for this 2-arm design (1:1 distribution of
placebo/verum). This calculation revealed a number of 50 subjects. Drawing into account
a drop out rate of 10%, we recommend a sample size of 56 subjects, 28 in each group.
Subjects will be randomized into blocks of 4 (2 verum and 2 placebos in each block) and
sequentially numbered (www.randomization.com). To guarantee a balanced distribution in
performance capability/VO2max between groups (verum vs. placebo) we will conduct
stratification via VO2max rank statistics. The allocation of the capsules/boxes will be
conducted after the completed 1st exercise test session. Boxes will be delivered by
mail and in 2 tranches (a 7 blocks or 28 subjects), separated by a week. This scheme
considers a one week period to check 28 subjects and therefore ensures equal duration
of treatment for all candidates.
STATISTICAL ANALYSES For blood and stool data we will use an univariate, two-factorial
analysis of variance (ANOVA). Factors: "treatment" (= placebo vs product) and "time" (=
week 0 vs week 12). For lactate and other performance diagnostic parameters we use a
three-factorial repeated measures ANOVA with the additional factor "session" (test 1,
2, 3). This statistical test method ensures the consideration of all before-, during-
and after- measurements. Further, we will use non-parametric tests, descriptive
statistics, and - if indicated - correlation analyses.
