Bentonitin İnsan Diyetlerinde Kullanımı
İngilizce özeti aşağıda verilen
bir
diğer 2005 tarihli çalışmada,
Kalsiyum bentonit kilinin insan diyetlerinde, bozulmuş gıdalardan dolayı oluşan riskleri yok etmede kullanımı ile ilgili kısa vadedeki güvenilirliği Kliniksel olarak araştırılmış ve çalışmalarda, Kalsiyum Bentonit Kilinin, istatiksel olarak herhangi bir risk taşımadığı gözlenmiştir.
Short-term safety evaluation of processed
calcium montmorillonite clay (NovaSil) in humans
J.-S. Wang MD, PhDa, H. Luoa, M.
Billama, Z. Wanga, H. Guana, L. Tanga, T. Goldstonb, E. Afriyie-Gyawuc,
C. Lovettb, J. Griswoldb, B. Brattinc, R. J. Taylorc, H. J. Huebnerc &
T. D. Phillipsc, pages 270-279 Received: 25 Jan 2005
Abstract
NovaSil clay (NS) provides significant
protection from the adverse effects of aflatoxins (AFs) in multiple animal
species by decreasing bioavailability from the gastrointestinal tract.
It is postulated that NS clay can be safely added to human diets to diminish
exposure and health risks from AF contaminated food. To determine the
safety and tolerance of NS in humans and establish dosimetry protocols
for long-term efficacy studies, a randomized and double-blinded phase
I clinical trial was conducted. Volunteers (20–45 yr in age), were clinically
screened for confirmation of their health status. Fifty subjects (23 males
and 27 females) were randomly divided into two groups: The low-dose group
received nine capsules containing 1.5 g/day, and the high-dose group received
nine capsules containing 3.0 g/day for a period of 2 wk. NS capsules were
manufactured in the same color and size and were distributed to each participant
three times a day at designated sites where follow-up was taken to record
any side effects and complaints. Blood and urine samples were collected
before and after the study for laboratory analysis. All participants completed
the trial and compliance was 99.1%. Mild GI effects were reported in some
participants. Symptoms included abdominal pain (6%, 3/50), bloating (4%,
2/50), constipation (2%, 1/50), diarrhea (2%, 1/50), and flatulence (8%,
4/50). No statistical significance was found between the two groups for
these adverse effects (p > 0.25). No significant differences were shown
in hematology, liver and kidney function, electrolytes, vitamins A and
E, and minerals in either group. These results demonstrate the relative
safety of NS clay in human subjects and will serve as a basis for long-term
human trials in populations at high risk for aflatoxicosis.
