Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2022-09-14
2024-12-12
Brief Summary
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While more is known about the role of phytochemicals in adult health, surprisingly little is known about phytochemical nutrition during pregnancy. This study focuses on a group of phytochemicals, called carotenoids, during pregnancy.
The study will determine if and why levels of carotenoids in the body change across the course of pregnancy. Understanding carotenoid nutrition during pregnancy will improve the understanding ofnutrition needs of expectant mothers and their infants. To study these questions, both health pregnant and non-pregnant female adults will report on their dietary intake and participate in body measurements, health surveys, and carotenoid measurements of eyes, skin, and blood at time points corresponding with the first, second, and third trimesters of pregnancy as well as post-partum.
Detailed Description
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The goal of this study is to better understand how and why body levels of carotenoids, change during pregnancy and the post-partum period. We will study whether these changes can be explained by pregnancy, a person's diet, and changes in body composition. We will study if changes in a female's carotenoid status are associated with changes in memory or thinking ability, levels of inflammation, and her infant's carotenoid levels.
Ultimately, this information can guide nutrition advice for future pregnant people.
This study involves 5 study visits for the pregnant or non-pregnant adult female participants with an option to enroll infants for the final, post-partum, visit. For the four follow-up visits, adult participants will have body measurements, will complete surveys, and will provide a blood sample. At the final visit, lactating participants will be asked to provide a milk sample. If enrolled, infant participants will provide an optional blood sample, have body measurements, have an optical skin measurement, and their participating adult guardian will complete an infant eating survey.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pregnant
Adult females between 18-40 years old who have a confirmed pregnancy.
Carotenoid Intake
Carotenoid intake assess by 24 hour dietary recalls
Serum carotenoid concentration
Serum total carotenoid concentration
Non-pregnant
Adult females between 18-40 years old who do not have a confirmed pregnancy.
Carotenoid Intake
Carotenoid intake assess by 24 hour dietary recalls
Serum carotenoid concentration
Serum total carotenoid concentration
Interventions
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Carotenoid Intake
Carotenoid intake assess by 24 hour dietary recalls
Serum carotenoid concentration
Serum total carotenoid concentration
Eligibility Criteria
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Inclusion Criteria
* a pregnancy confirmed by positive pregnancy test and/or ultrasound
* pre-pregnancy BMI 18.5-29.9 kg/m\^2
* can speak, read, and understand English
* agrees to take the prescribed daily prenatal multivitamin as recommended by their licensed prenatal healthcare provider throughout the study.
Non-pregnant group
* current BMI that is lean 18.5-29.9 kg/m\^
* can speak, read, and understand English
* agrees to continue taking any daily multivitamins or supplements throughout the study
* consumes alcohol moderately as outlined by current guidelines.
Infants
* born at term (37 weeks gestation or more)
* if infant was one of multiple births, only one sibling may be enrolled.
Exclusion Criteria
* currently uses tobacco, or drugs; consumes alcohol beyond current recommendations (zero in pregnancy, 1 drink daily average for non-pregnant)
* adult female currently taking any isolated carotenoid supplements or high carotenoid (\>2 mg/d) supplements
* adult female currently consumes an exclusively vegan or vegetarian diet
* adult female uses medications that interfere with dietary fat absorption
* adult female has history of endocrine disorders requiring hormone administration (with the exception of medically managed hypothyroidism).
* pregnant adult female has been informed by her doctor that she will need to take hormones during her pregnancy
* adult female has current vision condition or disease that prevents them from seeing clearly regardless of corrective lenses.
* adult female is currently lactating at enrollment.
18 Years
40 Years
FEMALE
Yes
Sponsors
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United States Department of Agriculture (USDA)
FED
Baylor College of Medicine
OTHER
Responsible Party
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Nancy Engelmann Moran
Assistant Professor
Locations
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USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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3092-51000-061-002S
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-46721
Identifier Type: -
Identifier Source: org_study_id