Avocado Consumption for Exclusive Breastfeeding

Overseen By Carol L Cheatham, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Gestational diabetes, Infant developmental delay, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

88 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Avocado, Hass Avocado, Avocatin B, AvoB for exclusive breastfeeding?

Research suggests that avocados, which are rich in essential nutrients like folate and potassium, as well as beneficial compounds such as fiber and healthy fats, may improve maternal health and breast milk quality. This implies that including avocados in the diet of breastfeeding mothers could potentially support better breastfeeding outcomes. ^{1 2 3 4 5}

Is avocado consumption safe for pregnant and breastfeeding women?

Avocados are considered safe and beneficial for pregnant and breastfeeding women as they are rich in essential nutrients like folate and potassium, as well as fiber and healthy fats, which can improve maternal health and breast milk quality. ^{1 3 5 6 7}

How does avocado consumption as a treatment for exclusive breastfeeding differ from other treatments?

Avocado consumption is unique because it provides essential nutrients like folate and potassium, which are often lacking in maternal diets, and contains beneficial compounds such as fiber and monounsaturated fats that can improve maternal health and breast milk quality, unlike other treatments that may not focus on these specific nutritional benefits. ^{1 6 8 9 10}

What is the purpose of this trial?

The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. Eighty-eight breastfeeding dyads, 3m postnatal, will participate in this study designed to: 1. To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks. 2. To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado. 3. To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group. To this end, healthy, lactating women who are 13 weeks postpartum and their infants will be enrolled. Mothers will be provided avocados on a bi-weekly basis and will be asked to consume an avocado a day. Infant cognition will be tested when the infants are 4.5 and 6 months of age. Milk samples and diet data will be collected and assayed on a bi-weekly basis.

Research Team

Carol L Cheatham, Ph.D.

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for healthy breastfeeding women who are 13 weeks postpartum and their infants. Participants will be asked to eat an avocado a day for 12 weeks. The study aims to see if avocados in the mother's diet can improve nutrients in breast milk and benefit infant brain development.

Inclusion Criteria

Planning to exclusively breastfeed to 6 months of age

Healthy lactating women at 13 weeks postpartum

Gave birth at 38 weeks or greater gestation without remarkable incident

Exclusion Criteria

Family history of avocado, latex, or banana allergies

Gestational diabetes

My infant has had seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to consume 5 avocados a week for 12 weeks or no avocados. Milk samples and diet data are collected bi-weekly.

12 weeks

Bi-weekly visits for milk sample collection and avocado supply

Follow-up

Participants are monitored for cognitive development outcomes in infants, including recognition memory and Bayley Scales of Infant Development.

6 weeks

3 visits (in-person) at 3, 4.5, and 6 months

Treatment Details

Interventions

• Avocado

Trial Overview The study tests whether eating five avocados per week affects the levels of choline, lutein, and fatty acids in human milk, which are important for infant brain development. It also looks at potential cognitive benefits for infants whose mothers consume avocados.

Participant Groups

Group I: Avocado Experimental Treatment 1 Intervention

Participants will be provided avocados and asked to consume an avocado a day for 12 weeks.

Group II: No Avocado Active Control 1 Intervention

Comparison arm in which no intervention occurs.

Avocado is already approved in Canada, United States for the following indications:

Approved in Canada as Avocado for:

• None specifically approved; however, components like Avocatin B are under investigation for diabetes management

Approved in United States as Avocado for:

• None specifically approved; however, components like Avocatin B are under investigation for diabetes management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Avocado Nutrition Center

Collaborator

Trials

4

Recruited

560+

Findings from Research

Maternal nutrition significantly impacts fertility, fetal development, and long-term health of offspring, making it crucial for pregnant and lactating women to consume nutrient-rich foods.

Avocados stand out as a unique source of essential nutrients like folate and potassium, as well as beneficial compounds such as fiber and monounsaturated fats, which can enhance maternal health and improve birth outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Avocados in Maternal Diets during the Periconceptional Period, Pregnancy, and Lactation. Comerford, KB., Ayoob, KT., Murray, RD., et al.[2019]

Beta-carotene supplementation in lactating mothers significantly increased their serum and milk beta-carotene levels, with increases of ninefold and sevenfold, respectively, after just three days of supplementation.

Importantly, this supplementation led to a significant increase in infant serum retinol levels, indicating that breast milk beta-carotene can effectively provide vitamin A for nursing infants, although maternal retinol levels did not change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term beta-carotene supplementation of lactating mothers consuming diets low in vitamin A. Canfield, LM., Taren, DL., Kaminsky, RG., et al.[2019]

Omega-3 fatty acids, especially DHA, are crucial for brain and retina development, and their intake during pregnancy and early life can positively influence growth and cognitive performance in children.

Breastfeeding is recommended for up to 2 years to ensure adequate intake of essential fats, and while increasing DHA through fish consumption or fortification is effective, more research is needed to confirm the benefits of omega-3 supplementation in undernourished children aged 6-24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential fats: how do they affect growth and development of infants and young children in developing countries? A literature review. Huffman, SL., Harika, RK., Eilander, A., et al.[2023]

A study of 121 healthy lactating Chinese mothers found that different dietary fatty acid patterns significantly influenced the fatty acid compositions in both maternal serum and breast milk, particularly affecting levels of polyunsaturated fatty acids (PUFAs).

Mothers with dietary patterns rich in long-chain polyunsaturated fatty acids (LC-PUFAs) showed better postpartum recovery, and their infants had improved growth metrics, indicating that maternal diet can have important implications for both maternal health and infant development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between dietary fatty acid patterns based on principal component analysis and fatty acid compositions of serum and breast milk in lactating mothers in Nanjing, China. Ding, Y., Yang, Y., Xu, F., et al.[2022]

DHA supplementation in breastfeeding mothers significantly increases the DHA content in both breast milk and maternal plasma, with increases ranging from 23% to 41% depending on the source of DHA (algae, eggs, or marine oil).

Infants of mothers who received DHA supplementation also showed increased DHA levels in their plasma phospholipids, with increases of 11% to 42%, indicating that maternal DHA intake positively impacts infant DHA status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of docosahexaenoic acid supplementation of lactating women on the fatty acid composition of breast milk lipids and maternal and infant plasma phospholipids. Jensen, CL., Maude, M., Anderson, RE., et al.[2018]

A meta-analysis of 65 studies involving 2474 women found that the average concentration of DHA in human breast milk is 0.32%, which is lower and more variable than the average concentration of AA at 0.47%.

The study highlights that DHA concentrations in breast milk are influenced by factors such as diet, particularly marine food consumption, and that there is a significant but low correlation between DHA and AA levels, indicating variability in the DHA to AA ratio across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Brenna, JT., Varamini, B., Jensen, RG., et al.[2023]

Breastfeeding provides essential nutrients, particularly lipids, which are crucial for infant energy and development, including important fatty acids that support cognitive and visual growth.

Maternal diet significantly influences the quality of lipids in breast milk, and high intake of trans fatty acids can negatively affect the synthesis of beneficial long-chain polyunsaturated fatty acids, highlighting the need for awareness about healthy fat consumption during pregnancy and breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The importance of essential fatty acids and the effect of trans fatty acids in human milk on fetal and neonatal development]. Tinoco, SM., Sichieri, R., Moura, AS., et al.[2019]

In Mexico, a significant 57% of lactating women were found to have vitamin A deficiency (VAD), which is concerning given the high prevalence of VAD in infants aged 0-2 years.

Infants in both urban and agricultural areas are not receiving adequate vitamin A from breast milk, covering only 66% and 49% of their dietary needs, highlighting the need for improved nutrition and weaning practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Dose-to-Mother' Deuterium Oxide Dilution Technique: An Accurate Strategy to Measure Vitamin A Intake in Breastfed Infants. Lopez-Teros, V., Limon-Miro, AT., Astiazaran-Garcia, H., et al.[2018]

The study found that lactating mothers in Hong Kong had low vitamin A intake and breastmilk retinol levels, indicating a potential deficiency despite their higher socioeconomic status, based on an analysis of 87 mothers' diets.

Higher maternal carotenoid intake was linked to increased levels of carotenoids in breastmilk, particularly lutein, suggesting that consuming more dark green vegetables can enhance both carotenoid and vitamin A content in breastmilk, which is important for infant development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carotenoids and Vitamin A in Breastmilk of Hong Kong Lactating Mothers and Their Relationships with Maternal Diet. Lu, Z., Chan, YT., Lo, KK., et al.[2023]

In a study involving 18 mother-infant pairs over six months of exclusive breastfeeding, it was found that the intake of specific fatty acids (FAs) from human milk, such as C15:0 and C18:2, positively correlated with infant growth, emphasizing the importance of these nutrients for development.

The research highlighted significant variations in the fatty acid composition of human milk across different mothers and throughout the lactation period, suggesting that individual maternal characteristics can influence the nutritional quality of breast milk and, consequently, infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fatty Acid Species and Quantity Consumed by the Breastfed Infant Are Important for Growth and Development. George, AD., Gay, MCL., Wlodek, ME., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Avocados in Maternal Diets during the Periconceptional Period, Pregnancy, and Lactation. [2019]

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

Short-term beta-carotene supplementation of lactating mothers consuming diets low in vitamin A. [2019]

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

Essential fats: how do they affect growth and development of infants and young children in developing countries? A literature review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Association between dietary fatty acid patterns based on principal component analysis and fatty acid compositions of serum and breast milk in lactating mothers in Nanjing, China. [2022]

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

Effect of docosahexaenoic acid supplementation of lactating women on the fatty acid composition of breast milk lipids and maternal and infant plasma phospholipids. [2018]

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

Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

[The importance of essential fatty acids and the effect of trans fatty acids in human milk on fetal and neonatal development]. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

'Dose-to-Mother' Deuterium Oxide Dilution Technique: An Accurate Strategy to Measure Vitamin A Intake in Breastfed Infants. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Carotenoids and Vitamin A in Breastmilk of Hong Kong Lactating Mothers and Their Relationships with Maternal Diet. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Fatty Acid Species and Quantity Consumed by the Breastfed Infant Are Important for Growth and Development. [2021]