Healthy NutritionMCAPSNCT06004479
Maternal Carotenoids Across Pregnancy Study
An observational study of Healthy Nutrition and Pregnancy Related, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition, Pregnancy Related
- What is being tested?
- Carotenoid Intake and Serum carotenoid concentration
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy adults are recruited from the community of the greater Houston, TX metropolitan area.
Who may be able to join
- Pregnant group
- 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
Show all 13Show fewer
- 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.
Who cannot join
- Metabolic, kidney, liver, digestive, or malabsorptive disorders with special dietary recommendations for the adult female or infant
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Effect of Pregnancy and Lactation on Carotenoid Status and Bioactivity
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.
Read the detailed description
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.
- Conditions
- Healthy Nutrition, Pregnancy Related
- Being tested
- Carotenoid Intake, Serum carotenoid concentration
- Keywords
- carotenoids, skin carotenoids, cognitive function, pregnancy nutrition, macular carotenoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid IntakeOther
Carotenoid intake assess by 24 hour dietary recalls
Serum carotenoid concentrationOther
Serum total carotenoid concentration
| Study group | Role | What they receive |
|---|---|---|
| Pregnant | Adult females between 18-40 years old who have a confirmed pregnancy. Receives: Other: Carotenoid Intake; Other: Serum carotenoid concentration | |
| Non-pregnant | Adult females between 18-40 years old who do not have a confirmed pregnancy. Receives: Other: Carotenoid Intake; Other: Serum carotenoid concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Total Carotenoid Concentrations - 1st Trimester Equivalent
Sum of all major carotenoid species in serum collected from fasting participant.
Measured: 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
Serum Total Carotenoid Concentrations - 2nd Trimester Equivalent
Sum of all major carotenoid species in serum collected from fasting participant.
Measured: 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Serum Total Carotenoid Concentrations - 3rd Trimester Equivalent
Sum of all major carotenoid species in serum collected from fasting participant.
Measured: 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Serum Total Carotenoid Concentrations - Post-partum
Sum of all major carotenoid species in serum collected from fasting participant.
Measured: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Secondary outcomes (8)
Skin Carotenoid Concentrations - 1st Trimester Equivalent
Skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)
Macular pigment optical density - 1st Trimester Equivalent
Macular pigment optical density measured by heterochromatic flicker photometry
Measured: 1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)
Skin Carotenoid Concentrations - 2nd Trimester Equivalent
Skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 2nd Trimester Equivalent: 22 weeks 0d - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Macular pigment optical density - 2nd Trimester Equivalent
Macular pigment optical density measured by heterochromatic flicker photometry
Measured: 2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Skin Carotenoid Concentrations - 3rd Trimester Equivalent
Skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Macular pigment optical density - 3rd Trimester Equivalent
Macular pigment optical density measured by heterochromatic flicker photometry
Measured: 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Skin Carotenoid Concentrations - Post-partum Equivalent
Skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Macular pigment optical density - Post-partum Equivalent
Macular pigment optical density measured by heterochromatic flicker photometry
Measured: Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start14 Sep 2022
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Nancy Engelmann Moran, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004479
- Sponsor's protocol ID
- H-46721
- Other IDs
- 3092-51000-061-002S
- Acronym
- MCAPS
- Status last verified
- Dec 2024
- First submitted
- 12 May 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregnancy and Lactation on Carotenoid Status and Bioactivity
- ClinicalTrials.gov ID
- NCT06004479
- Acronym / sponsor ID
- MCAPS / H-46721
- Conditions
- Healthy Nutrition, Pregnancy Related
- Keywords
- carotenoids, skin carotenoids, cognitive function, pregnancy nutrition, macular carotenoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Other: Carotenoid Intake, Other: Serum carotenoid concentrationAdult females between 18-40 years old who have a confirmed pregnancy. |
| Non-pregnant | – | Other: Carotenoid Intake, Other: Serum carotenoid concentrationAdult females between 18-40 years old who do not have a confirmed pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults are recruited from the community of the greater Houston, TX metropolitan area.
Key inclusion criteria (13 listed)
- Pregnant group
- 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.
Key exclusion criteria (9 listed)
- Metabolic, kidney, liver, digestive, or malabsorptive disorders with special dietary recommendations for the adult female or infant
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotenoid IntakeCarotenoid intake assess by 24 hour dietary recalls | Other | Non-pregnant, Pregnant |
| Serum carotenoid concentrationSerum total carotenoid concentration | Other | Non-pregnant, Pregnant |
Primary outcome
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)
Sum of all major carotenoid species in serum collected from fasting participant.
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)
Sum of all major carotenoid species in serum collected from fasting participant.
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)
Sum of all major carotenoid species in serum collected from fasting participant.
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)
Sum of all major carotenoid species in serum collected from fasting participant.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Nutrition
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Healthy Volunteers, Overweight
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Nutrition and Pregnancy Related, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.