xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004479</url>
    </required_header>
    <id_info>
      <org_study_id>H-46721</org_study_id>
      <secondary_id>3092-51000-061-002S</secondary_id>
      <nct_id>NCT06004479</nct_id>
    </id_info>
    <brief_title>Maternal Carotenoids Across Pregnancy Study</brief_title>
    <acronym>MCAPS</acronym>
    <official_title>Effect of Pregnancy and Lactation on Carotenoid Status and Bioactivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Agriculture (USDA)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor College of Medicine</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Before infants are born, they depend on their mother to provide the nutrients necessary to&#xD;
        grow and develop, such as iron, folic acid, iodine and other vitamins and minerals. Pregnant&#xD;
        people also rely on good nutrition to support their own health. In addition to essential&#xD;
        nutrients, vitamins, and minerals, there are other natural components found in fruits and&#xD;
        vegetables, called phytochemicals, that may support maternal and fetal health during&#xD;
        pregnancy.&#xD;
  &#xD;
        While more is known about the role of phytochemicals in adult health, surprisingly little is&#xD;
        known about phytochemical nutrition during pregnancy. This study focuses on a group of&#xD;
        phytochemicals, called carotenoids, during pregnancy.&#xD;
  &#xD;
        The study will determine if and why levels of carotenoids in the body change across the&#xD;
        course of pregnancy. Understanding carotenoid nutrition during pregnancy will improve the&#xD;
        understanding ofnutrition needs of expectant mothers and their infants. To study these&#xD;
        questions, both health pregnant and non-pregnant female adults will report on their dietary&#xD;
        intake and participate in body measurements, health surveys, and carotenoid measurements of&#xD;
        eyes, skin, and blood at time points corresponding with the first, second, and third&#xD;
        trimesters of pregnancy as well as post-partum.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        What a pregnant person eats is important for their own health and the health of their infant&#xD;
        during pregnancy and after birth. Fruits and vegetables contain colorful substances called&#xD;
        &quot;carotenoids&quot; which support the nutritional needs of the pregnant person and the infant, may&#xD;
        fight inflammation, and may even benefit the person's memory and thinking ability. A person's&#xD;
        carotenoid status can be measured with a blood sample and with optical measurements of the&#xD;
        skin and eye. What isn't known, is if or why a pregnant person's carotenoid status changes&#xD;
        over the course of pregnancy and the early post-partum period, and if those changes have&#xD;
        consequences for pregnant person's and infant's health.&#xD;
  &#xD;
        The goal of this study is to better understand how and why body levels of carotenoids, change&#xD;
        during pregnancy and the post-partum period. We will study whether these changes can be&#xD;
        explained by pregnancy, a person's diet, and changes in body composition. We will study if&#xD;
        changes in a female's carotenoid status are associated with changes in memory or thinking&#xD;
        ability, levels of inflammation, and her infant's carotenoid levels.&#xD;
  &#xD;
        Ultimately, this information can guide nutrition advice for future pregnant people.&#xD;
  &#xD;
        This study involves 5 study visits for the pregnant or non-pregnant adult female participants&#xD;
        with an option to enroll infants for the final, post-partum, visit. For the four follow-up&#xD;
        visits, adult participants will have body measurements, will complete surveys, and will&#xD;
        provide a blood sample. At the final visit, lactating participants will be asked to provide a&#xD;
        milk sample. If enrolled, infant participants will provide an optional blood sample, have&#xD;
        body measurements, have an optical skin measurement, and their participating adult guardian&#xD;
        will complete an infant eating survey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 14, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Serum Total Carotenoid Concentrations - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Sum of all major carotenoid species in serum collected from fasting participant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Total Carotenoid Concentrations - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Sum of all major carotenoid species in serum collected from fasting participant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Total Carotenoid Concentrations - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Sum of all major carotenoid species in serum collected from fasting participant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Total Carotenoid Concentrations - Post-partum</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Sum of all major carotenoid species in serum collected from fasting participant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skin Carotenoid Concentrations - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Skin carotenoid score measured by pressure-mediated reflection spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular pigment optical density - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Macular pigment optical density measured by heterochromatic flicker photometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin Carotenoid Concentrations - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0d - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Skin carotenoid score measured by pressure-mediated reflection spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular pigment optical density - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Macular pigment optical density measured by heterochromatic flicker photometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin Carotenoid Concentrations - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Skin carotenoid score measured by pressure-mediated reflection spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular pigment optical density - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Macular pigment optical density measured by heterochromatic flicker photometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin Carotenoid Concentrations - Post-partum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Skin carotenoid score measured by pressure-mediated reflection spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular pigment optical density - Post-partum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Macular pigment optical density measured by heterochromatic flicker photometry</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Subjective memory function - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation(Week 0 if non-pregnant)</time_frame>
      <description>Subjective memory function assessed by MAC-Q</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective memory function - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Subjective memory function assessed by MAC-Q</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective memory function - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Subjective memory function assessed by MAC-Q</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective memory function - Post-partum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Subjective memory function assessed by MAC-Q</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum IL-6 - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Serum concentrations of IL-6</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum IL-6 - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Serum concentrations of IL-6</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum IL-6 - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Serum concentrations of IL-6</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum IL-6 - Postpartum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Serum concentrations of IL-6</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum hsCRP - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Serum concentrations of high sensitivity C-reactive protein</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum hsCRP - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22w0d-23w6d gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Serum concentrations of high sensitivity C-reactive protein</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum hsCRP - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Serum concentrations of high sensitivity C-reactive protein</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum hsCRP - Postpartum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days-8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Serum concentrations of high sensitivity C-reactive protein</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum sTNFr-II - 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNFr-II</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum sTNFr-II - 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNFr-II</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum sTNFr-II - 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNFr-II</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum sTNFr-II - Post-partum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Serum concentrations of sTNFr-II</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum TNF-alpha- 1st Trimester Equivalent</measure>
      <time_frame>1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNF-alpha</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum TNF-alpha- 2nd Trimester Equivalent</measure>
      <time_frame>2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNF-alpha</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum TNF-alpha- 3rd Trimester Equivalent</measure>
      <time_frame>3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days gestation (week 22-23 if non-pregnant)</time_frame>
      <description>Serum concentrations of sTNF-alpha</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum TNF-alpha- Post-partum Equivalent</measure>
      <time_frame>Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)</time_frame>
      <description>Serum concentrations of sTNF-alpha</description>
    </other_outcome>
    <other_outcome>
      <measure>Infant serum carotenoid concentration</measure>
      <time_frame>7 weeks 0 days - 8 weeks 6 days post-partum</time_frame>
      <description>Serum total carotenoid concentration in 7-8 week old infants</description>
    </other_outcome>
    <other_outcome>
      <measure>Infant serum carotenoid concentration</measure>
      <time_frame>Post-partum: 7 weeks 0 days - 8 weeks 6 days post-partum</time_frame>
      <description>Serum total carotenoid concentration in 7-8 week old infants</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Healthy Nutrition</condition>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>Pregnant</arm_group_label>
      <description>Adult females between 18-40 years old who have a confirmed pregnancy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-pregnant</arm_group_label>
      <description>Adult females between 18-40 years old who do not have a confirmed pregnancy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Carotenoid Intake</intervention_name>
      <description>Carotenoid intake assess by 24 hour dietary recalls</description>
      <arm_group_label>Non-pregnant</arm_group_label>
      <arm_group_label>Pregnant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Serum carotenoid concentration</intervention_name>
      <description>Serum total carotenoid concentration</description>
      <arm_group_label>Non-pregnant</arm_group_label>
      <arm_group_label>Pregnant</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        serum, human milk&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults are recruited from the community of the greater Houston, TX metropolitan&#xD;
          area.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Pregnant group&#xD;
  &#xD;
            -  a pregnancy confirmed by positive pregnancy test and/or ultrasound&#xD;
  &#xD;
            -  pre-pregnancy BMI 18.5-29.9 kg/m^2&#xD;
  &#xD;
            -  can speak, read, and understand English&#xD;
  &#xD;
            -  agrees to take the prescribed daily prenatal multivitamin as recommended by their&#xD;
               licensed prenatal healthcare provider throughout the study.&#xD;
  &#xD;
          Non-pregnant group&#xD;
  &#xD;
            -  current BMI that is lean 18.5-29.9 kg/m^&#xD;
  &#xD;
            -  can speak, read, and understand English&#xD;
  &#xD;
            -  agrees to continue taking any daily multivitamins or supplements throughout the study&#xD;
  &#xD;
            -  consumes alcohol moderately as outlined by current guidelines.&#xD;
  &#xD;
          Infants&#xD;
  &#xD;
            -  born at term (37 weeks gestation or more)&#xD;
  &#xD;
            -  if infant was one of multiple births, only one sibling may be enrolled.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metabolic, kidney, liver, digestive, or malabsorptive disorders with special dietary&#xD;
               recommendations for the adult female or infant&#xD;
  &#xD;
            -  currently uses tobacco, or drugs; consumes alcohol beyond current recommendations&#xD;
               (zero in pregnancy, 1 drink daily average for non-pregnant)&#xD;
  &#xD;
            -  adult female currently taking any isolated carotenoid supplements or high carotenoid&#xD;
               (&gt;2 mg/d) supplements&#xD;
  &#xD;
            -  adult female currently consumes an exclusively vegan or vegetarian diet&#xD;
  &#xD;
            -  adult female uses medications that interfere with dietary fat absorption&#xD;
  &#xD;
            -  adult female has history of endocrine disorders requiring hormone administration (with&#xD;
               the exception of medically managed hypothyroidism).&#xD;
  &#xD;
            -  pregnant adult female has been informed by her doctor that she will need to take&#xD;
               hormones during her pregnancy&#xD;
  &#xD;
            -  adult female has current vision condition or disease that prevents them from seeing&#xD;
               clearly regardless of corrective lenses.&#xD;
  &#xD;
            -  adult female is currently lactating at enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nancy E. Moran, PhD</last_name>
      <phone>713-798-0520</phone>
      <email>nancy.moran@bcm.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nancy E. Moran, PhD</last_name>
        <phone>713-798-0520</phone>
        <email>nancy.moran@bcm.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.bcm.edu/healthcare/clinical-trials/h-46721</url>
      <description>Study Webpage and Study Interest Form</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Nancy Engelmann Moran</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>carotenoids</keyword>
    <keyword>skin carotenoids</keyword>
    <keyword>cognitive function</keyword>
    <keyword>pregnancy nutrition</keyword>
    <keyword>macular carotenoids</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carotenoids</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004479
  org study id: H-46721
  secondary id: 3092-51000-061-002S
  nct id: NCT06004479
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Before infants are born, they depend on their mother to provide the nutrients necessary to
        grow and develop, such as iron, folic acid, iodine and other vitamins and minerals. Pregnant
        people also rely on good nutrition to support their own health. In addition to essential
        nutrients, vitamins, and minerals, there are other natural components found in fruits and
        vegetables, called phytochemicals, that may support maternal and fetal health during
        pregnancy.
  
        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.
  What a pregnant person eats is important for their own health and the health of their infant
        during pregnancy and after birth. Fruits and vegetables contain colorful substances called
        "carotenoids" which support the nutritional needs of the pregnant person and the infant, may
        fight inflammation, and may even benefit the person's memory and thinking ability. A person's
        carotenoid status can be measured with a blood sample and with optical measurements of the
        skin and eye. What isn't known, is if or why a pregnant person's carotenoid status changes
        over the course of pregnancy and the early post-partum period, and if those changes have
        consequences for pregnant person's and infant's health.
  
        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.
  observational model: Case-Control
  time perspective: Prospective
  measure: Serum Total Carotenoid Concentrations - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Sum of all major carotenoid species in serum collected from fasting participant.
  measure: Serum Total Carotenoid Concentrations - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Sum of all major carotenoid species in serum collected from fasting participant.
  measure: Serum Total Carotenoid Concentrations - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
  description: Sum of all major carotenoid species in serum collected from fasting participant.
  measure: Serum Total Carotenoid Concentrations - Post-partum
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Sum of all major carotenoid species in serum collected from fasting participant.
  measure: Skin Carotenoid Concentrations - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Skin carotenoid score measured by pressure-mediated reflection spectroscopy
  measure: Macular pigment optical density - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Macular pigment optical density measured by heterochromatic flicker photometry
  measure: Skin Carotenoid Concentrations - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0d - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Skin carotenoid score measured by pressure-mediated reflection spectroscopy
  measure: Macular pigment optical density - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Macular pigment optical density measured by heterochromatic flicker photometry
  measure: Skin Carotenoid Concentrations - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
  description: Skin carotenoid score measured by pressure-mediated reflection spectroscopy
  measure: Macular pigment optical density - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
  description: Macular pigment optical density measured by heterochromatic flicker photometry
  measure: Skin Carotenoid Concentrations - Post-partum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Skin carotenoid score measured by pressure-mediated reflection spectroscopy
  measure: Macular pigment optical density - Post-partum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Macular pigment optical density measured by heterochromatic flicker photometry
  measure: Subjective memory function - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation(Week 0 if non-pregnant)
  description: Subjective memory function assessed by MAC-Q
  measure: Subjective memory function - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Subjective memory function assessed by MAC-Q
  measure: Subjective memory function - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
  description: Subjective memory function assessed by MAC-Q
  measure: Subjective memory function - Post-partum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Subjective memory function assessed by MAC-Q
  measure: Serum IL-6 - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Serum concentrations of IL-6
  measure: Serum IL-6 - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Serum concentrations of IL-6
  measure: Serum IL-6 - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
  description: Serum concentrations of IL-6
  measure: Serum IL-6 - Postpartum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Serum concentrations of IL-6
  measure: Serum hsCRP - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Serum concentrations of high sensitivity C-reactive protein
  measure: Serum hsCRP - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22w0d-23w6d gestation (or week 11-12 if non-pregnant)
  description: Serum concentrations of high sensitivity C-reactive protein
  measure: Serum hsCRP - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
  description: Serum concentrations of high sensitivity C-reactive protein
  measure: Serum hsCRP - Postpartum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days-8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Serum concentrations of high sensitivity C-reactive protein
  measure: Serum sTNFr-II - 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Serum concentrations of sTNFr-II
  measure: Serum sTNFr-II - 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Serum concentrations of sTNFr-II
  measure: Serum sTNFr-II - 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
  description: Serum concentrations of sTNFr-II
  measure: Serum sTNFr-II - Post-partum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Serum concentrations of sTNFr-II
  measure: Serum TNF-alpha- 1st Trimester Equivalent
  time frame: 1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)
  description: Serum concentrations of sTNF-alpha
  measure: Serum TNF-alpha- 2nd Trimester Equivalent
  time frame: 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
  description: Serum concentrations of sTNF-alpha
  measure: Serum TNF-alpha- 3rd Trimester Equivalent
  time frame: 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days gestation (week 22-23 if non-pregnant)
  description: Serum concentrations of sTNF-alpha
  measure: Serum TNF-alpha- Post-partum Equivalent
  time frame: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
  description: Serum concentrations of sTNF-alpha
  measure: Infant serum carotenoid concentration
  time frame: 7 weeks 0 days - 8 weeks 6 days post-partum
  description: Serum total carotenoid concentration in 7-8 week old infants
  measure: Infant serum carotenoid concentration
  time frame: Post-partum: 7 weeks 0 days - 8 weeks 6 days post-partum
  description: Serum total carotenoid concentration in 7-8 week old infants
  arm group label: Pregnant
  description: Adult females between 18-40 years old who have a confirmed pregnancy.
  arm group label: Non-pregnant
  description: Adult females between 18-40 years old who do not have a confirmed pregnancy.
  intervention type: Other
  intervention name: Carotenoid Intake
  description: Carotenoid intake assess by 24 hour dietary recalls
  arm group label: Non-pregnant
  arm group label: Pregnant
  intervention type: Other
  intervention name: Serum carotenoid concentration
  description: Serum total carotenoid concentration
  arm group label: Non-pregnant
  arm group label: Pregnant
  serum, human milk
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nancy E. Moran, PhD
  phone: 713-798-0520
  email: nancy.moran@bcm.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.bcm.edu/healthcare/clinical-trials/h-46721
  description: Study Webpage and Study Interest Form
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Nancy Engelmann Moran
  investigator title: Assistant Professor
  mesh term: Carotenoids
  sharing ipd: Undecided