- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413710
Effects of Soy Protein on Body Composition and General Health in Healthy Children
October 3, 2019 updated by: DuPont Nutrition and Health
A Randomized, Controlled, Parallel Study to Assess the Effects of Soy Protein on Body Composition and General Health Parameters in Healthy Children
The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is male or female, 8-11 years of age, inclusive.
- Subject is judged to be in good health on the basis of medical history.
- Subject is a regular consumer (5 out of 7 d) of breakfast and snacks.
- Subject has a BMI-for-age within the 75th and 95th percentile (Appendix 3).
- Subject is willing to follow dietary changes consistent with the Dietary Guidelines for Americans 2010 throughout the study period (Appendix 5).
- Subject/guardian understands the study procedures and signs forms providing assent/informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
Exclusion Criteria:
- Subject has a diagnosis of attention deficit disorder, with or without hyperactivity.
- Subject requires special educational services related to cognitive or attentional disorders, neurologic diseases, and physical disabilities.
- Subject is a girl who has begun menses.
- Subject is at Tanner Stage IV or higher, as described by parent/guardian per self-assessment questionnaire (Appendix 2).
- Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
- Subject has a known allergy or sensitivity to the study foods.
- Use of sleep aids within 2 weeks of visit 1 (week -1) and throughout the study.
- Subject has extreme dietary habits, in the judgment of the Investigator.
- Subject has used any weight loss supplements, programs, or meal replacement products (within 2 weeks of visit 1, week -1) intended to alter body weight (Appendix 1).
- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa or binge eating) diagnosed by a health professional.
- Involvement in any clinical trial within 30 d prior to the screening visit.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Protein Group
Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov).
Subjects in this intervention group will not receive study provided foods.
|
Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov).
Subjects in this intervention group will not receive study provided foods.
|
Experimental: Soy Protein Group
Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the USDA MyPlate program (www.choosemyplate.gov)
with the incorporation of two servings of study food providing soy protein per day.
|
Daily consumption of 2 food products, each providing 15g of soy protein per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in body composition
Time Frame: week 0, week 12
|
DXA
|
week 0, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
March 17, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- BIO-1501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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