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Effectiveness of DIM Supplements to Increase 2-OHE1/16 Ratio (EDIMI216OHE1)

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ClinicalTrials.gov Identifier: NCT02525159
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Estela Ytelina Godínez Martínez, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Brief Summary:
Breast cancer is a public health problem in Mexico and its incidence rises when the woman is still premenopausal. Estrogen metabolism has been linked to breast cancer. 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. 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, 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. 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. 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). A clinical, randomized, double-blind study was performed with women attending on the urogynecology service of Institute National of Perinatology. Subjects were premenopausal women over 34 years who were healthy. 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. 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. 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. Analysis of the 2OHE1 and 16αOHE1 were determined using a commercially kit ESTRAMET™. The change in metabolites median concentrations and RMEU was assessed through the Wilcoxon test and these differences between groups through U Mann-Whitney test.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: DIM pills Other: Placebo Pill Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of DIM Supplements to Increase 2-OHE1/16 Ratio in Premenopausal Mexican Women With Risk of Breast Cancer
Study Start Date : August 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DIM pills
75 mg of 3,3´-diindolylmethane (DIM) once a day for 30 days
Dietary Supplement: DIM pills
Two pills of BioResponse DIM® 150 are equal to 75 mg of DIM pure
Other Name: BioResponse DIM® 150

Placebo Comparator: Placebo pills
2 pills once a day for 30 days
Other: Placebo Pill
Placebo pills, proportionate by the same provider, vials and pills were the same size, shape and material containing the DIM pills




Primary Outcome Measures :
  1. Change in ratio of estrogen metabolites 2OHE1:16αOHE1 in urine (REMU) [ Time Frame: At day 0, at day 30 after the supplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo to evaluate the permanence of the response ]

Secondary Outcome Measures :
  1. Adherence [ Time Frame: Dialy, after the day 0 until the end of the supplementation of DIM or placebo (day 30) ]
    A schedule was provided to the patients to record the daily intake of the supplement DIM/placebo

  2. Presence of Side Effects [ Time Frame: At day 0 and 30 days after the supplementation of DIM or placebo ]
    A schedule was provided to the patients to record daily the presence of side effects that have been reported in other studies such as diarrhea, nausea , vomiting , headache and flatulence.


Other Outcome Measures:
  1. Prolonged use of hormonal contraceptives [ Time Frame: At day 0 ]
    Use for five years or more

  2. Late pregnancy or nulliparity [ Time Frame: At day 0 ]
    First pregnancy after 35 years or no living children

  3. Age [ Time Frame: At day 0 ]
  4. Family history of breast cancer [ Time Frame: At day 0 ]
    Have at least one first-degree or second degree family, who has had or have the disease

  5. Early menarche [ Time Frame: At day 0 ]
    Age at first period at twelve or more

  6. Body Mass Index (IMC) [ Time Frame: At day 0, at day 30 after the suplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo ]
  7. % of body fat [ Time Frame: At day 0, at day 30 after the suplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo ]
  8. Waist perimeter [ Time Frame: At day 0, at day 30 after the suplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo ]
  9. Physical activity [ Time Frame: At day 0, at day 30 after the suplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo ]
    More than 150 minutes per week

  10. Socioeconomic level [ Time Frame: At day 0 ]
    According to the committee of socioeconomic levels of the Mexican Association of Market Research Agencies and Public Opinion (AMAI)

  11. Consumption of cruciferous vegetables [ Time Frame: At day 0, at day 30 after the suplementation of DIM or placebo and 30 days after the end of the suplementation of DIM or placebo ]
    Number of portions per day (1 cup raw or 1/2 cup cooked) of any cruciferous vegetables



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Ages Eligible for Study:   35 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal woman
  • Not pregnant or planning to become pregnant
  • That are not nursing
  • Nonsmokers
  • No alcohol addiction
  • Regular menstrual cycles
  • 2-hydroxyestrone /16 urinary ratio less or equal to 0.9

Exclusion Criteria:

  • Take drugs that interfere with estrogen metabolism like hormonal contraceptives , cimetidine , antidepressants, thyroxine , supplements of n-3 fatty acids or soy
  • Endocrine or liver disease
  • Pregnancy

Additional Information:
Publications:
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Responsible Party: Estela Ytelina Godínez Martínez, Researcher in Medical Sciences B, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT02525159     History of Changes
Other Study ID Numbers: SDEI.PTID.05.3(CM)
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Estela Ytelina Godínez Martínez, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
3,3'-diindolylmethane
premenopause
2-hydroxyestrone
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
3,3'-diindolylmethane
2-hydroxyestrone
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents