Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study
Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P
Nutrition and cancer · 243 citas
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Alimentación controladaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- Comida provista por los investigadores
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Johns Hopkins University
- Gobierno
- National Cancer Institute
- Gobierno
- National Center for Research Resources
- Gobierno
- NCRR NIH HHS
- Gobierno
- NCI NIH HHS
- Subvenciones
- National Center for Research Resources (M01 RR-00052); National Cancer Institute (R01 CA093780)
Según 5 financiadores declarados.
Publicación
- Publicado
- 2006-07-01 · Nutr Cancer · vol. 55 · número 1 · págs. 53–62
- Editorial
- Routledge
- Citado
- 330 citas · más que el 97% de estudios similares · 5.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 24 trabajos
- Acceso
- De pago
- Áreas de investigación
- Genomics, phytochemicals, and oxidative stress · Phytochemicals and Antioxidant Activities · Pharmacogenetics and Drug Metabolism
- Palabras clave
- broccoli sprouts, glucosinolates, isothiocyanates, glucoraphanin, sulforaphane, pharmacokinetics, safety and tolerability, liver function, thyroid function, cruciferous vegetables, chemoprevention
- MeSH
- liver, humans, brassica, neoplasms, isothiocyanates, thyroid hormones, glucosinolates, plant extracts, anticarcinogenic agents, blood chemical analysis, diet, cohort studies, double-blind method, consumer product safety, dose-response relationship, drug, adult, middle aged, female, male
8 autores
- Theresa A. Shapiro🇺🇸Johns Hopkins University; Johns Hopkins Medicine
- Jed W. Fahey🇺🇸Johns Hopkins University
- Albena T. Dinkova‐Kostova🇺🇸Johns Hopkins University
- Walter David Holtzclaw🇺🇸Johns Hopkins University
- Katherine K. Stephenson🇺🇸Johns Hopkins University
- Kristina L. Wade🇺🇸Johns Hopkins University
- Lingxiang Ye🇺🇸Johns Hopkins University
- Paul Talalay🇺🇸Johns Hopkins University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Broccoli sprouts are widely consumed in many parts of the world. There have been no reported concerns with respect to their tolerance and safety in humans. A formal phase I study of safety, tolerance, and pharmacokinetics appeared justified because these sprouts are being used as vehicles for the delivery of the glucosinolate glucoraphanin and its cognate isothiocyanate sulforaphane [1-isothiocyanato-(4R)-(methylsulfinyl)butane] in clinical trials. Such trials have been designed to evaluate protective efficacy against development of neoplastic and other diseases. A placebo-controlled, double-blind, randomized clinical study of sprout extracts containing either glucosinolates (principally glucoraphanin, the precursor of sulforaphane) or isothiocyanates (principally sulforaphane) was conducted on healthy volunteers who were in-patients on our clinical research unit. The subjects were studied in three cohorts, each comprising three treated individuals and one placebo recipient. Following a 5-day acclimatization period on a crucifer-free diet, the broccoli sprout extracts were administered orally at 8-h intervals for 7 days (21 doses), and the subjects were monitored during this period and for 3 days after the last treatment. Doses were 25 micromol of glucosinolate (cohort A), 100 micromol of glucosinolate (cohort B), or 25 micromol of isothiocyanate (cohort C). The mean cumulative excretion of dithiocarbamates as a fraction of dose was very similar in cohorts A and B (17.8 +/- 8.6% and 19.6 +/- 11.7% of dose, respectively) and very much higher and more consistent in cohort C (70.6 +/- 2.0% of dose). Thirty-two types of hematology or chemistry tests were done before, during, and after the treatment period. Indicators of liver (transaminases) and thyroid [thyroid-stimulating hormone, total triiodothyronine (T3), and free thyroxine (T4)] function were examined in detail. No significant or consistent subjective or objective abnormal events (toxicities) associated with any of the sprout extract ingestions were observed.
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