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More info
You can access this
clinical trial
if you have
Puberty and Body Composition
and you are
between 6 and 12
years old
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

Background: Children in industrialized and developing countries have a higher tendency to present earlier signs of puberty. One hypothesis includes the hormonal effects of phytoestrogens found in soy products. Objective: to examine the association between consumption of soy-based food in early infancy and childhood and the incidence of early or precocious puberty and overweight in school-aged children. Methods: the study population for this case control study is randomized from a prospectively followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to those who were allergic to milk, and thus consumed only soy based formula and food during infancy and childhood (soy group) and a randomized control group who consumed non-soy based intake. For both groups data are available of food habits during infancy and collected from 3 days food diaries during the current study. Physical examination, including weight , height, blood pressure and Tanner Pubertal Staging will performed annually.

Provided treatments

  • Behavioral: soy based formula at infancy

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02908971. The sponsor of the trial is Assaf-Harofeh Medical Center and it is looking for 98 volunteers for the current phase.
Official trial title:
Association Between Soy Based Formula Consumption During Infancy and the Timing of Pubertal Signs and BMI-SDS