Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily DietNCT02413710
Effects of Soy Protein on Body Composition and General Health in Healthy Children
A study testing Soy protein containing foods and Dietary Guidance in people with Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet, run by DuPont Nutrition and Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet
- What is being tested?
- Soy protein containing foods and Dietary Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: 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.
- Being tested
- Soy protein containing foods, Dietary Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy protein containing foodsOther
Daily consumption of 2 food products, each providing 15g of soy protein per day.
Dietary GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Protein Group | Active comparator | 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. Receives: Behavioral: Dietary Guidance |
| Soy Protein Group | Experimental | 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. Receives: Other: Soy protein containing foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body composition
DXA
Measured: week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413710
- Sponsor's protocol ID
- BIO-1501
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2015
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel Study to Assess the Effects of Soy Protein on Body Composition and General Health Parameters in Healthy Children
- ClinicalTrials.gov ID
- NCT02413710
- Acronym / sponsor ID
- BIO-1501
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Protein Group | Active comparator | Behavioral: Dietary GuidanceSubjects 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 | Experimental | Other: Soy protein containing foodsSubjects 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy protein containing foodsDaily consumption of 2 food products, each providing 15g of soy protein per day. | Other | Soy Protein Group |
| Dietary GuidanceSubjects 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. | Behavioural | Usual Protein Group |
Primary outcome
change in body composition
Time frame: week 0, week 12
DXA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein containing foods and Dietary Guidance in people with Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet, run by DuPont Nutrition and Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body composition (time frame: week 0, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.