Healthy ChildrenPODSNCT06276426
Plants Optimizing Development Study (PODS)
A study testing Soy foods and Non-Soy Plant-Based Foods in people with Healthy Children, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Soy foods and Non-Soy Plant-Based Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 30 Sep 2026
- 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
- Child assent and parent/guardian consent
- Free of any food allergy
- 8-11 years of age
- Tanner scale score of ≤ 2
- 20/20 or corrected vision
- No antibiotic usage in the past 3 months
- ≤1 serving/d of soy food habitual consumption
Who cannot join
- Non-assent or consent by child assent and/or parent/guardian
- Presence of any food allergy
- Younger than 8 years or older than 11 years
- Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome)
- Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease
- Tanner scale score of > 2
Show all 9Show fewer
- Not 20/20 or uncorrected vision
- Antibiotic usage in the past 3 months
- >1 serving/d of soy food habitual consumption
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois
Urbana, Illinois, 61801
Naiman Khan, PhD, RD, 217-300-2197, nakhan2@illinois.edu
Naiman Khan, PhD, RD
About this study
Official title: Plants Optimizing Development Study
This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.
Read the detailed description
The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.
- Conditions
- Healthy Children
- Being tested
- Soy foods, Non-Soy Plant-Based Foods
- Keywords
- soy, isoflavones, cognition, body composition, fecal microbiota, metabolic risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy foodsOther
Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
Non-Soy Plant-Based FoodsOther
Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.
| Study group | Role | What they receive |
|---|---|---|
| Soy | Experimental | The experimental group will be asked to consume 2 servings/day of soy foods for 3 months Receives: Other: Soy foods |
| Non-Soy Plant-Based Foods | Active comparator | The control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months Receives: Other: Non-Soy Plant-Based Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex steroid excretion
urinary concentration of androgen and estrogenic steroids
Measured: 3 months (Baseline vs Follow-up)
Secondary outcomes (8)
Gut microbiota
Gut microbiota will be assessed using a fecal sample. Outcomes will include α-diversity/community richness and evenness (Shannon Index), β-diversity (microbial structures), and Firmicutes:Bacteroidetes ratio.
Measured: 3 months (Baseline vs Follow-up)
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Measured: 3 months (Baseline vs Follow-up)
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Measured: 3 months (Baseline vs Follow-up
Hippocampal-dependent Relational memory
Spatial memory task accuracy.
Measured: 3 months (Baseline vs Follow-up)
Body Composition
DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.
Measured: 3 months (Baseline vs Follow-up)
Metabolic Markers
Fasted venous blood will be collected from the antecubital vein of the arm to measure TG, LDL, HDL, TC, and FG using the Piccolo Xpress Analyzer (Abaxis, Inc.).
Measured: 3 months (Baseline vs Follow-up)
Pubertal Staging
Tanner pubertal stage will be assessed using the Growing and Changing Questionnaire. The survey consists of line drawings23 representing the Tanner stages for genital size and for pubic hair and to record which drawing most closely represents the child's stage.
Measured: 3 months (Baseline vs Follow-up)
Cognitive Abilities and Academic Achievement
Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement
Measured: 3 months (Baseline vs Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Mar 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Soy Nutrition Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276426
- Sponsor's protocol ID
- 24468
- Acronym
- PODS
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plants Optimizing Development Study
- ClinicalTrials.gov ID
- NCT06276426
- Acronym / sponsor ID
- PODS / 24468
- Conditions
- Healthy Children
- Keywords
- soy, isoflavones, cognition, body composition, fecal microbiota, metabolic risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Soy Nutrition Institute
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Feb 2024 (actual)
- 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.
This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.
Detailed description
The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy | Experimental | Other: Soy foodsThe experimental group will be asked to consume 2 servings/day of soy foods for 3 months |
| Non-Soy Plant-Based Foods | Active comparator | Other: Non-Soy Plant-Based FoodsThe control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child assent and parent/guardian consent
- Free of any food allergy
- 8-11 years of age
- Tanner scale score of ≤ 2
- 20/20 or corrected vision
Key exclusion criteria (9 listed)
- Non-assent or consent by child assent and/or parent/guardian
- Presence of any food allergy
- Younger than 8 years or older than 11 years
- Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome)
- Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease
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 foodsSoy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes. | Other | Soy |
| Non-Soy Plant-Based FoodsPea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes. | Other | Non-Soy Plant-Based Foods |
Primary outcome
Sex steroid excretion
Time frame: 3 months (Baseline vs Follow-up)
urinary concentration of androgen and estrogenic steroids
8 secondary outcomes
Gut microbiota
Time frame: 3 months (Baseline vs Follow-up)
Attentional Accuracy
Time frame: 3 months (Baseline vs Follow-up)
Attentional Reaction Time
Time frame: 3 months (Baseline vs Follow-up
Hippocampal-dependent Relational memory
Time frame: 3 months (Baseline vs Follow-up)
Body Composition
Time frame: 3 months (Baseline vs Follow-up)
Metabolic Markers
Time frame: 3 months (Baseline vs Follow-up)
Pubertal Staging
Time frame: 3 months (Baseline vs Follow-up)
Cognitive Abilities and Academic Achievement
Time frame: 3 months (Baseline vs Follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 foods and Non-Soy Plant-Based Foods in people with Healthy Children, run by University of Illinois at Urbana-Champaign 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naiman Khan, PhD, RD (2173002197, nakhan2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex steroid excretion (time frame: 3 months (Baseline vs Follow-up)). 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 17 Apr 2024.