Soy Foods vs Non-Soy Plant-Based Foods for Healthy Children

(PODS Trial)

Overseen By Naiman Khan, PhD, RD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: Food allergy, Neurological disorders, Endocrine disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. However, it does mention that children with certain medical conditions or recent antibiotic use are excluded.

What data supports the effectiveness of the treatment involving soy foods for healthy children?

Research shows that soy can help malnourished children improve their height and weight, and plant-based diets have been effective in managing weight in overweight or obese children. This suggests that soy foods might support healthy growth and weight management in children. ^{1 2 3 4 5}

Is soy safe for children to consume?

Research suggests that soy foods are generally safe for children and do not cause adverse hormonal effects or affect puberty. However, some children may be allergic to soy, though most outgrow this allergy by age 10. More research is needed to fully understand the effects of soy on children's development. ^{6 7 8 9 10}

How is the Soy Foods vs Non-Soy Plant-Based Foods treatment unique for healthy children?

This treatment is unique because it compares the effects of soy foods with non-soy plant-based foods on children's health, focusing on body composition and development. Unlike other treatments, it specifically examines the role of soy isoflavones, which can act like estrogen in the body, potentially influencing growth and development differently than other plant-based diets. ^{1 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

The PODS trial is for healthy children aged 8-11 with no food allergies, normal or corrected vision, and low daily soy intake. They must not have used antibiotics recently or have certain neurological, genetic, endocrine, metabolic, or gastrointestinal conditions.

Inclusion Criteria

20/20 or corrected vision

Free of any food allergy

I haven't taken antibiotics in the last 3 months.

Exclusion Criteria

Presence of any food allergy

>1 serving/d of soy food habitual consumption

Tanner scale score of > 2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2 servings/day of soy foods or non-soy plant-based foods for 3 months

12 weeks

Regular visits for monitoring and sample collection

Follow-up

Participants are monitored for changes in soy food acceptance and other outcomes after treatment

4 weeks

Treatment Details

Interventions

• Plants Optimizing Development Study (PODS)

Trial Overview This study tests the impact of a mixed-soy diet compared to non-soy foods on hormones, body composition, metabolism risk factors, gut bacteria and thinking skills in kids over three months. It also looks at how this affects their liking for soy foods afterwards.

Participant Groups

Group I: Soy Experimental Treatment 1 Intervention

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

Group II: Non-Soy Plant-Based Foods Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Soy Nutrition Institute

Collaborator

Trials

2

Recruited

100+

Findings from Research

Soy-based infant formulas have been widely used in the U.S. since 1909 and currently represent a significant part of the infant formula market, highlighting their established role in infant nutrition.

The review aims to evaluate the potential of genetically modified soybeans for delivering therapeutic agents in infant formulas, discussing both the benefits and drawbacks of soy-based formulas while proposing hypotheses for future research and public policy considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy-Based Therapeutic Baby Formulas: Testable Hypotheses Regarding the Pros and Cons. Westmark, CJ.[2023]

In a study of 83 malnourished children aged 1 to 4 years, those treated with soya showed over 80% improvement in weight and height in the youngest group (1 to 2 years old) over a 12-month period.

The soya treatment significantly reduced the degree of malnutrition and restored nutritional status in many cases, highlighting the potential of soya as an effective intervention for malnourished children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management with soya of 1-4 years-old suffering malnutrition]. García-Garro, AJ., Gernández-Flores, MG., Ramos-Ortega, G.[2023]

The Healthy Eating Lifestyle Program (HELP) showed no excess weight gain in overweight or obese Hispanic/Latino children aged 5-12, indicating its potential effectiveness in weight management.

Parents and guardians participating in the program experienced a significant decrease in BMI, particularly among men, suggesting that culturally tailored, family-centered plant-based diet interventions can enhance pediatric weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating an Increase in Plant-Based Food Choices into a Model of Culturally Responsive Care for Hispanic/Latino Children and Adults Who Are Overweight/Obese. Singh, PN., Steinbach, J., Nelson, A., et al.[2021]

A study involving 29 children who consumed soy-based formula and 60 control children found no significant differences in growth parameters (height and BMI) between the two groups, suggesting that soy formula does not negatively impact growth.

The research also showed no association between the consumption of soy-based formula in infancy and early signs of puberty, indicating that soy formula is safe in terms of growth and pubertal development for children with cow milk allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of soy-based infant formula is not associated with early onset of puberty. Sinai, T., Ben-Avraham, S., Guelmann-Mizrahi, I., et al.[2021]

In a 2-month crossover study involving 20 children and adolescents with developmental disabilities, Pediasure with added soy fiber (PSF10) was found to be well tolerated, showing no significant differences in gastrointestinal symptoms or growth compared to standard Pediasure (PS).

There was a trend indicating that children on the fiber-supplemented formula required fewer elimination aids for bowel movements, suggesting a potential benefit of the added fiber in improving stool regularity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance of a pediatric fiber formula in developmentally disabled children. Tolia, V., Ventimiglia, J., Kuhns, L.[2023]

Soyfoods are rich in isoflavones, which may offer protective benefits against chronic diseases without adverse hormonal effects in children, based on limited studies.

Consuming soy during childhood and adolescence may significantly reduce the risk of developing breast cancer later in life, suggesting that soy can be a healthy dietary choice for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health impact of childhood and adolescent soy consumption. Messina, M., Rogero, MM., Fisberg, M., et al.[2023]

Soy-based infant formulas contain significant levels of phytoestrogens, with average concentrations of genistein and daidzein at 87 and 49 micrograms per gram, respectively, which can lead to a daily intake of approximately 3 mg/kg body weight for infants.

In contrast, no phytoestrogens were found in dairy-based formulas or human breast milk, highlighting the unique exposure risk from soy products, and suggesting a need for further research on the potential effects of these compounds on infant development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phytoestrogens in soy-based infant foods: concentrations, daily intake, and possible biological effects. Irvine, CH., Fitzpatrick, MG., Alexander, SL.[2023]

The study found that soy-based infant formulas in Brazil contain significant levels of isoflavones (65.9 mg/kg) and soyasaponins (55.0 mg/100g), with infants consuming about 0.8 mg/day/kg of isoflavones, which is double the intake of Japanese adults.

Infants consuming these formulas also have a soyasaponin intake of 9.2 mg/day/kg, which is up to six times higher than what vegetarians typically consume from beans, highlighting the need for further research on the potential biological effects of these compounds in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoflavones and soyasaponins in soy infant formulas in Brazil: profile and estimated consumption. Fonseca, ND., Villar, MP., Donangelo, CM., et al.[2023]

A study involving 51 prepubertal children showed that consuming a soy protein-based supplement (SPS) for 12 months led to significant improvements in height and BMI in girls, indicating potential benefits for growth during this developmental stage.

However, the intake of SPS did not affect sexual maturation or the onset of puberty in either boys or girls, suggesting that while it may support growth metrics, it does not influence hormonal development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy protein supplement intake for 12 months has no effect on sexual maturation and may improve nutritional status in pre-pubertal children. Duitama, SM., Zurita, J., Cordoba, D., et al.[2020]

Infants exposed to isoflavone-containing breast milk and those fed tofu showed significantly higher isoflavone levels in their urine and plasma compared to their mothers after the mothers consumed soy, indicating that infants absorb isoflavones effectively from these sources.

Breastfed infants had lower urinary isoflavone excretion compared to their mothers, while tofu-fed infants had much higher levels, suggesting that the method of isoflavone intake (breast milk vs. tofu) influences the bioavailability and systemic exposure of isoflavones in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoflavones in breastfed infants after mothers consume soy. Franke, AA., Halm, BM., Custer, LJ., et al.[2018]

In a study of 452 Chinese children aged 6-9, a higher score on the healthful plant-based diet index (hPDI) was linked to increased lean mass and lower fat mass percentage, indicating better body composition.

Conversely, a higher score on the unhealthful plant-based diet index (uPDI) was associated with lower lean mass and higher fat mass percentage, emphasizing the importance of distinguishing between healthy and unhealthy plant foods for children's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-based diets and body composition in Chinese omnivorous children aged 6-9 years old: A cross-sectional study. Chen, G., Su, M., Chu, X., et al.[2022]

In a study of 283 preschool-aged children, those with higher overall plant-based dietary index (oPDI) scores consumed more beneficial nutrients like dietary fiber and fruits, but had lower intakes of important nutrients like calcium and vitamin D.

Children with higher healthful plant-based dietary index (hPDI) scores had better overall nutrient intake, consuming more encouraged foods and fewer unhealthy options, suggesting that promoting plant-based diets can positively influence children's nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-Based Dietary Indices in Relation to Nutrient and Food Group Intakes in Preschool-Aged Children. Acosta, PFC., Landon, OA., Ribau, ZJ., et al.[2023]

Infants fed soy formula, which contains soy protein isolate with isoflavones, do not show long-term adverse effects from early exposure, supporting normal growth and development.

Research indicates that soy isoflavones can act differently depending on the context, and diets made with soy protein isolate may have distinct health benefits compared to those with purified isoflavones, warranting further investigation into their long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health consequences of early soy consumption. Badger, TM., Ronis, MJ., Hakkak, R., et al.[2018]

A longitudinal study involving over 300 children has shown that those fed soy formula (SF) grow and develop normally without any adverse effects, similar to those fed breast milk (BM) or milk-based formula (MF).

Neonatal pig studies indicate that while SF has different effects compared to BM and MF, it can promote health benefits such as increased bone quality, suggesting that SF may support normal growth and development effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health implications of soy infant formula. Badger, TM., Gilchrist, JM., Pivik, RT., et al.[2023]

References

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Soy-Based Therapeutic Baby Formulas: Testable Hypotheses Regarding the Pros and Cons. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

[Management with soya of 1-4 years-old suffering malnutrition]. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Incorporating an Increase in Plant-Based Food Choices into a Model of Culturally Responsive Care for Hispanic/Latino Children and Adults Who Are Overweight/Obese. [2021]

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Consumption of soy-based infant formula is not associated with early onset of puberty. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance of a pediatric fiber formula in developmentally disabled children. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Health impact of childhood and adolescent soy consumption. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Phytoestrogens in soy-based infant foods: concentrations, daily intake, and possible biological effects. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Isoflavones and soyasaponins in soy infant formulas in Brazil: profile and estimated consumption. [2023]

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Soy protein supplement intake for 12 months has no effect on sexual maturation and may improve nutritional status in pre-pubertal children. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Isoflavones in breastfed infants after mothers consume soy. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Plant-based diets and body composition in Chinese omnivorous children aged 6-9 years old: A cross-sectional study. [2022]

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Plant-Based Dietary Indices in Relation to Nutrient and Food Group Intakes in Preschool-Aged Children. [2023]

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The health consequences of early soy consumption. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

The health implications of soy infant formula. [2023]