Pears + Sweet Potatoes for Infant Development

(IMiND Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Antibiotics, Iron supplements, Probiotics

Disqualifiers: GI tract abnormalities, Cesarean birth, Immunodeficiency, others

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

Compensation: Varies

Number of Visits: 14

Duration: 11 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how introducing certain solid foods affects the gut health and development of infants who have been exclusively breastfed. Researchers aim to observe changes in gut bacteria, which significantly influence development, when infants begin eating pears or sweet potatoes. Mothers with healthy, single babies who are ready for solids and plan to continue breastfeeding may be suitable candidates, particularly if they reside near UC Davis in California. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research on infant nutrition and gut health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, mothers must refrain from giving their infants certain supplements and non-study foods during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that sweet potatoes and pears, common ingredients in baby foods, can contain heavy metals like lead and arsenic. Research indicates that sweet potatoes often have higher levels of lead, around 55 parts per billion (ppb). Pears, including pear juice, can also contain lead and arsenic. Although no safe level of heavy metals exists, experts suggest serving a variety of foods to reduce exposure.

These foods are widely available and often given to babies. Parents should be aware of these findings but understand that these foods are generally considered safe when given in moderation. Always consult a healthcare provider if there are concerns about adding new foods to a baby's diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of using pears and sweet potatoes to boost infant development because these foods are natural, nutrient-rich options. Unlike standard infant nutritional supplements, which might include synthetic ingredients or fortified vitamins, pears and sweet potatoes provide a whole-food approach packed with essential vitamins and fiber. This trial could reveal if a simple dietary addition of these fruits and vegetables can have significant benefits for infant growth and development, offering an accessible and holistic alternative to current options.

What evidence suggests that this trial's treatments could be effective for infant development?

This trial will compare the effects of sweet potatoes and pears on infant development. Research has shown that sweet potatoes, which participants in this trial may receive, provide important nutrients like vitamin A, zinc, and iron, essential for a baby's growth. They are particularly beneficial as supplementary foods in resource-limited areas. Studies have found that orange-fleshed sweet potatoes are high in beta-carotene, which the body converts into vitamin A, and young children tend to enjoy them.

Pears, another treatment option in this trial, are often used in baby foods and are known to be safe for infants. While specific nutrients are not highlighted in the sources, pears are commonly included in baby foods because they are naturally sweet and easy to digest. Both sweet potatoes and pears are popular first foods that can help introduce solid foods to infants while supporting their growth and gut health. ^{1 3 6 7 8}

Who Is on the Research Team?

Jennifer Smilowitz, PhD

Principal Investigator

University of California, Davis

Lisa Oakes, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for mother-infant pairs near UC Davis, California. Infants must be born full-term and exclusively breastfed for at least 5 months, ready to start solids between 4-7.5 months old without any GI abnormalities or recent antibiotic use. Mothers should be healthy, aged 21-45, non-smokers, and willing to avoid giving infants formula or supplements during the study.

Inclusion Criteria

Mother-infant pairs who live within a specified radius from University of California, Davis campus or University of California, Davis Medical Center

Mothers who plan to exclusively breastfeed their infants for at least 5 months of age and plan to continue to breastfeed with solids and/or infant formula until 12 months of age

I am willing to avoid giving my infant certain foods during the study.

Exclusion Criteria

Infants who have consumed specified items within defined timeframes

Mothers who live in more than one location

Infants born by cesarean section

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants consume either sweet potato or pear baby food for 7 days, followed by a 4-day washout period of exclusive breast milk

11 days

Daily monitoring

Follow-up

Participants are monitored for changes in fecal microbiota composition and other developmental measures

180 days

Regular assessments at days 14, 19, 25, 29, 60, 90, 120, 150, 180

What Are the Treatments Tested in This Trial?

Interventions

• Pears
• Sweet Potatos

Trial Overview The study investigates how introducing solid foods like pears and sweet potatoes to exclusively breastfed infants affects their gut microbiome and development. It tracks changes in fecal microbiota as these new foods are introduced and relates them to developmental milestones.

How Is the Trial Designed?

Group I: Sweet Potatos Experimental Treatment 1 Intervention

Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row.

Group II: Pears Experimental Treatment 1 Intervention

Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

UC Davis Foods for Health Institute

Collaborator

Trials

1

Recruited

100+

Mengniu Dairy

Collaborator

Trials

1

Recruited

100+

Citations

1. researchgate.net researchgate.net/publication/357702150_Effect_of_Avocado_Pear_Inclusion_on_Nutrient_Composition_and_Sensory_Qualities_of_a_Complementary_Food

Effect of Avocado Pear Inclusion on Nutrient Composition ... Avocado pear inclusion in complementary food can help in the reduction of malnutrition due to its contribution to caloric and micronutrient ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6860076/

Types of fruits and vegetables used in commercial baby ... Commercial baby foods lack a variety of vegetables that will promote development of bitter tastes. Methods. Data collection. A database was created using ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0956713524007357

A closer look at infant food safety: A comprehensive review ... The objective of this article is to compare the levels of contaminants in Commercial Baby Foods (CBFs) in comparison to Homemade Baby Foods (HMBFs), and Common ...

4. hbbf.org hbbf.org/sites/default/files/2022-12/BabyFoodReport_ENGLISH_R6_0.pdf

What's in my baby's food? New tests of 168 baby foods commissioned by. Healthy Babies Bright Futures (HBBF) found toxic heavy metals in 95 percent of containers tested. One in four baby.

5. nestle.com nestle.com/sites/default/files/asset-library/documents/r_and_d/publications/food-consumption-patterns-of-infants-and-toddlers.pdf

Findings from the Feeding Infants and Toddlers Study ( ... The Feeding Infants and Toddlers Study (FITS) is a unique survey that provides national estimates of early feeding behaviors, including ...

6. cdph.ca.gov cdph.ca.gov/Programs/CCDPHP/DEODC/CLPPB/Pages/BabyFoodSafety.aspx

Baby Food Safety - CDPH - CA.gov Juice, especially apple, pear, and grape, can contain lead and arsenic. Breastmilk or formula are recommended for the first year of life. Water ...

7. usapears.org usapears.org/how-to-introduce-pears-to-babies/

How to Introduce Pears to Babies It is safe to leave on if the skin and flesh are really ripe and soft. Your baby may spit it out, but this is great texture exposure ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11574642/

Use of baby food products during the complementary ... It is recommended that infants are introduced to complementary foods from 6 months old, moving from a solely milk diet to eating a family diet by 12 months ...