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

102 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Pears and Sweet Potatoes for infant development?

The research suggests that having a variety of fruits and vegetables available at home can improve children's intake of these foods, which is important for their development. Additionally, a diverse diet, including fruits and vegetables like pears and sweet potatoes, is linked to better growth and developmental outcomes in children. ^{1 2 3 4 5}

Is it safe for infants to consume pears and sweet potatoes?

Research shows that sweet potatoes are commonly used in commercial baby foods and are generally considered safe for infants. Encouraging the consumption of vegetables like sweet potatoes can help meet nutritional needs, as they are good sources of important nutrients. ^{1 6 7 8 9}

How does the Pears + Sweet Potatoes treatment for infant development differ from other treatments?

The Pears + Sweet Potatoes treatment is unique because it combines naturally sweet and nutritious foods to potentially enhance infants' acceptance of fruits and vegetables, which can be crucial for their development. Unlike other treatments that may rely on added sugars or commercial baby foods, this approach uses whole foods to promote a balanced diet and improve dietary variety. ^{10 11 12 13 14}

What is the purpose of this trial?

This study is examining the relationship between infant nutrition, gut health, and development. The fecal microbiota changes and develops, in large part due to the food that infants eat. These changes are important for many aspects of development. This study is designed to examine how the fecal microbiota changes when exclusively breastfed infants are first introduced to solid food, and how changes of the fecal microbiota are related to other aspects of development.

Research Team

Jennifer Smilowitz, PhD

Principal Investigator

University of California, Davis

Lisa Oakes, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Home environment predictors of vegetable and fruit intakes among Australian children aged 18 months. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Developmental trajectories of eating behaviors and cross-lagged associations with weight across infancy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Maternal feeding self-efficacy and fruit and vegetable intakes in infants. Results from the SAIDI study. [2022]

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

Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Low dietary diversity is associated with linear growth faltering and subsequent adverse child developmental outcomes in rural Democratic Republic of the Congo (REDUCE program). [2022]

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

Nutrient Intakes and Vegetable and White Potato Consumption by Children Aged 1 to 3 Years. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Fruit and vegetable consumption before and during pregnancy and developmental delays in offspring aged 2 years in Japan. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Are regional and remote Western Australian children eating for good health? An investigation into fruit and vegetable consumption. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Types of fruits and vegetables used in commercial baby foods and their contribution to sugar content. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Relationships between acceptance of sour taste and fruit intakes in 18-month-old infants. [2022]

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

Savoring Sweet: Sugars in Infant and Toddler Feeding. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The relationship between maternal prenatal and postnatal vegetable intake and repeated measures of infant vegetable intake frequency in a national U.S. sample. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Sweetness of Chilean Infants' Diets: Methodology and Description. [2023]

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

Commercial baby food consumption and dietary variety in a statewide sample of infants receiving benefits from the special supplemental nutrition program for women, infants, and children. [2022]