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Association Between Soy Based Formula in Infancy and Puberty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02908971
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Puberty and Body Composition Behavioral: soy based formula at infancy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association Between Soy Based Formula Consumption During Infancy and the Timing of Pubertal Signs and BMI-SDS
Study Start Date : May 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Group/Cohort Intervention/treatment
Soy based formula
"soy group" will include children from the children who had milk allergy, and consumed a soy-based substitute formula for longer than three months and agreed to participate in this study.
Behavioral: soy based formula at infancy
The intervention is only past history of soy consumption

Healthy control
The control group will included children (at a rate of 2:1) who will be assigned randomly from the healthy population at the initial cohort, and who will agree to participate.

Primary Outcome Measures :
  1. Age of adrenarche signs [ Time Frame: 5 years ]
    Age of adrenarche signs will be compared between soy and control groups

  2. Age of gonadarche signs [ Time Frame: 5 years ]
    Age of gonadarche signs will be compared between soy and control groups

Secondary Outcome Measures :
  1. comparison of rate of Overweight and obesity [ Time Frame: 5 years ]
    BMI-SDS will be compared between groups

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is based on a large cohort study initiated and performed during 2004-2006 by Katz Y et al , which followed prospectively all newborns born during this time period at Assaf Haroffeh Medical Center, Zerifin, Israel . The study looked into their nutritional intake, development of sensitivity to milk and milk allergies. The population included a total of 13019 children, out of which 66 developed an IgE-mediated Cow Milk Allergy (CMA), 71 developed milk-sensitivity, and 12638 were healthy. Our study population included all CMA group and a randomized group from the healthy population (nested cohort).

Inclusion Criteria: All participants of initial cohort of children born 2004-2006 -

Exclusion Criteria: Those from soy group who did not consume soy based formula. Those from healthy control who did consume soy formula.

Refusal for physical examination.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02908971

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Contact: Marianna Rachmiel, MD
Contact: Avital Leshem

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Assaf Haroffeh Medical center Recruiting
Zerifin, Israel, 70300
Contact: Marianna Rachmiel, MD    972-8-9542007   
Principal Investigator: Marianna Rachmiel, MD         
Principal Investigator: Galia Askapa, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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Principal Investigator: Marianna Rachmiel, MD Assaf Haroffeh Medical Center

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Responsible Party: Assaf Harofeh MC, Assaf harofeh Medical Center, Assaf-Harofeh Medical Center Identifier: NCT02908971     History of Changes
Other Study ID Numbers: 257/15
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
soy based formula