Effects of Soy Protein on Body Composition and General Health in Healthy Children

NCT ID: NCT02413710

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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.

Conditions

Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dietary Guidance

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Soy protein containing foods

Intervention Type: OTHER

Daily consumption of 2 food products, each providing 15g of soy protein per day.

Interventions

Soy protein containing foods

Daily consumption of 2 food products, each providing 15g of soy protein per day.

Intervention Type: OTHER

Dietary Guidance

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

DuPont Nutrition and Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biofortis Clinical Research

Addison, Illinois, United States

Countries

United States

Other Identifiers

BIO-1501

Identifier Type: -

Identifier Source: org_study_id