102 Participants Needed

Pears + Sweet Potatoes for Infant Development

(IMiND Trial)

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

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.12345

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.16789

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.1011121314

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

JS

Jennifer Smilowitz, PhD

Principal Investigator

University of California, Davis

LO

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.
See 5 more

Exclusion Criteria

Infants who have consumed specified items within defined timeframes
Mothers who live in more than one location
Infants born by cesarean section
See 11 more

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
2Treatment groups
Experimental Treatment
Group I: Sweet PotatosExperimental Treatment1 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: PearsExperimental Treatment1 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.

Find a Clinic Near You

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

Home environment predictors of vegetable and fruit intakes among Australian children aged 18 months. [2020]
Developmental trajectories of eating behaviors and cross-lagged associations with weight across infancy. [2023]
Maternal feeding self-efficacy and fruit and vegetable intakes in infants. Results from the SAIDI study. [2022]
Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial. [2023]
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]
Nutrient Intakes and Vegetable and White Potato Consumption by Children Aged 1 to 3 Years. [2023]
Fruit and vegetable consumption before and during pregnancy and developmental delays in offspring aged 2 years in Japan. [2022]
Are regional and remote Western Australian children eating for good health? An investigation into fruit and vegetable consumption. [2019]
Types of fruits and vegetables used in commercial baby foods and their contribution to sugar content. [2020]
Relationships between acceptance of sour taste and fruit intakes in 18-month-old infants. [2022]
Savoring Sweet: Sugars in Infant and Toddler Feeding. [2018]
The relationship between maternal prenatal and postnatal vegetable intake and repeated measures of infant vegetable intake frequency in a national U.S. sample. [2022]
Sweetness of Chilean Infants' Diets: Methodology and Description. [2023]
14.United Statespubmed.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]
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