Personal data: Name, date of birth, address, phone, marital status and occupation. On the same date that each woman has signed the letter, another appointment was scheduled between day 12 and 15 of the menstrual cycle for the following assessments:
Once the woman read out the letter, understood it and agreed to participate, the signing of this was requested. Once explained the study to the patients, women who met the criteria for inclusion were cited to provide an informed consent letter mentioning them that they had the freedom to clarify any doubt that might arise. When women had a REMU equal or greater than 0.9, provide result and dietary guidance focused on maintaining BMI in normal range (19.0-24.9) or decrease (BMI more than or equal to 25) weight and the increase in the consumption of fruits and vegetables.Īctivities for women inclusion in the study of DIM supplementation: Provide result and invite women who present REMU less than 0.9 to participate in the project of supplementation with DIM. Quantify the concentrations of metabolites of estrogens in the urine for detect the presence of REMU less than 0.9. Interviewing these women to corroborate the inclusion and exclusion criteria. The purpose of this study was to evaluate the effectiveness of supplementation with 3,3´-Diindolylmethane (DIM) to increase the urinary ratio of estrogen metabolites 2OHE1:16alphaOHE1 (RMEU) in women at risk of breast cancer to contribute to generate a tool of early prevention of this disease.Īctivities for detect women with REMU less than 0.9:Ĭheck every day in the Institute National of Perinatology urogynecology service, clinical records of the women who attending consultations in order to verify the inclusion and exclusion criteria.
Condition or diseaseĭietary Supplement: DIM pills Other: Placebo Pill The change in metabolites median concentrations and RMEU was assessed through the Wilcoxon test and these differences between groups through U Mann-Whitney test. Analysis of the 2OHE1 and 16αOHE1 were determined using a commercially kit ESTRAMET™. All urine samples were collected from the women before DIM or placebo ingestion, after 30 days of DIM or placebo ingestion and finally after another 30 days once suspended supplementation. Patients were randomly assigned to one of two groups: one received orally at a daily dose of 75 mg of DIM for a period of 30 days and other group received orally at a daily placebo for a period of 30 days. The inclusion criteria's was had a RMEU less than 0.9 and were excluded for any medical condition, medication, or dietary or lifestyle habit that might interfere with estrogen metabolism. Subjects were premenopausal women over 34 years who were healthy. A clinical, randomized, double-blind study was performed with women attending on the urogynecology service of Institute National of Perinatology. The purpose of this study was to evaluate the effectiveness of supplementation with DIM to increase urinary RMEU in premenopausal women at risk of Breast Cancer (RMEU less than 0.9).
In the case of DIM, only a pilot study has explored its effect in postmenopausal women with personal history of breast cancer in early stages, reporting an increase in the concentrations of 2OHE1. Several studies, evaluate the pharmacokinetics and effect of I3C supplementation, finding that 300 to 600 mg of this compound are well tolerated and able to promote formation of 2OHE1 in women when supplemented for one month. Other studies have showed that the active compounds of cruciferous vegetables, indole-3-carbinol (I3C) and its dimer, 3'3'diindolylmethane (DIM) induce benign pathway of metabolism of estrogens producing 2OHE1. Several studies reported that high concentrations of 2 hydroxyestrone (2OHE1) in urine have a protective effect for this neoplasia, whereas high concentrations of 16 alpha-hydroxyestrone (16αOHE1) in urine have the opposite effect, further has been reported that women with a ratio of estrogen metabolites 2OHE1:16αOHE1 in urine (REMU) less than 0.9, have ten times the risk of developing Breast Cancer than those women with an RMEU equal or more than 0.9. Estrogen metabolism has been linked to breast cancer. Why Should I Register and Submit Results?īreast cancer is a public health problem in Mexico and its incidence rises when the woman is still premenopausal.
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