Clinical trial NCT02413710: Effects of Soy Protein on Body Composition and General Health in Healthy Children
Official title: A Randomized, Controlled, Parallel Study to Assess the Effects of Soy Protein on Body Composition and General Health Parameters in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet
Lead sponsor: DuPont Nutrition and Health
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2015-04-10
Enrollment: 47
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Subject is male or female, 8-11 years of age, inclusive.
2. Subject is judged to be in good health on the basis of medical history.
3. Subject is a regular consumer (5 out of 7 d) of breakfast and snacks.
4. Subject has a BMI-for-age within the 75th and 95th percentile (Appendix 3).
5. Subject is willing to follow dietary changes consistent with the Dietary Guidelines for Americans 2010 throughout the study period (Appendix 5).
6. 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:

1. Subject has a diagnosis of attention deficit disorder, with or without hyperactivity.
2. Subject requires special educational services related to cognitive or attentional disorders, neurologic diseases, and physical disabilities.
3. Subject is a girl who has begun menses.
4. Subject is at Tanner Stage IV or higher, as described by parent/guardian per self-assessment questionnaire (Appendix 2).
5. Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
6. Subject has a known allergy or sensitivity to the study foods.
7. Use of sleep aids within 2 weeks of visit 1 (week -1) and throughout the study.
8. Subject has extreme dietary habits, in the judgment of the Investigator.
9. 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).
10. Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa or binge eating) diagnosed by a health professional.
11. Involvement in any clinical trial within 30 d prior to the screening visit.
12. 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.

Primary outcomes:
measure: change in body composition
timeFrame: week 0, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
Study officials:
References: