Plants Optimizing Development Study (PODS) | NCT06276426

Studies
Plants Optimizing Development Study (PODS)

NCT06276426

Sponsor

University of Illinois at Urbana-Champaign

Status

Recruiting

Last Update Posted

Apr 17, 2024Actual

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Healthy Children

Interventions

Soy foods
Non-Soy Plant-Based Foods

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2024Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Feb 16, 2024

First Submission Date that Met QC Criteria

Feb 16, 2024

First Posted Date

Feb 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Name	Class
Soy Nutrition Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Soy	Experimental	The experimental group will be asked to consume 2 servings/day of soy foods for 3 months	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	Other: Non-Soy Plant-Based Foods

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soy foods	Other	Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.	Soy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sex steroid excretion	urinary concentration of androgen and estrogenic steroids	3 months (Baseline vs Follow-up)

Secondary Outcomes

Measure	Description	Time Frame
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.	3 months (Baseline vs Follow-up)
Attentional Accuracy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Not 20/20 or uncorrected vision
Antibiotic usage in the past 3 months
>1 serving/d of soy food habitual consumption

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naiman Khan, PhD, RD	Contact	2173002197		nakhan2@illinois.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois	Recruiting	Urbana	Illinois	61801	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045730	Soy Foods

Ancestor Terms

ID	Term
D000074421	Fermented Foods
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D000067075	Vegetable Products

Browse Leaves

Not provided

Browse Branches

Not provided