Recruiting

Observational Study

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT06276426

Conditions

Healthy Children

Eligibility Criteria

Sex: All

Age: 8 - 11

Healthy Volunteers: Accepted

Interventions

Soy foods

Non-Soy Plant-Based Foods

Study Details

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.

Conditions

Healthy Children

Study ID

NCT06276426

Start date

Mar 18, 2024

Status verified date

Apr, 2024

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 11

Healthy Volunteers: Accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Soy

The experimental group will be asked to consume 2 servings/day of soy foods for 3 months

active comparator: Non-Soy Plant-Based Foods

The control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months

Interventions

Soy foods

Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.

Non-Soy Plant-Based Foods

Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.

Primary outcome measure

  • Sex steroid excretion [ Time Frame: 3 months (Baseline vs Follow-up) ]

Central Contacts and Locations

Central contacts

Naiman Khan, PhD, RD

2173002197nakhan2@illinois.edu

Locations

University of Illinois

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Naiman Khan, PhD, RD

217-300-2197nakhan2@illinois.edu

Principal Investigator:

Naiman Khan, PhD, RD

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

  • soy
  • isoflavones
  • cognition
  • body composition
  • fecal microbiota
  • metabolic risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2024-04-17.