Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004479
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-05-12
Brief Title:
Maternal Carotenoids Across Pregnancy Study
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Effect of Pregnancy and Lactation on Carotenoid Status and Bioactivity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCAPS
Brief 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 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
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 persons memory and thinking ability A persons carotenoid status can be measured with a blood sample and with optical measurements of the skin and eye What isnt known is if or why a pregnant persons carotenoid status changes over the course of pregnancy and the early post-partum period and if those changes have consequences for pregnant persons and infants 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 persons diet and changes in body composition We will study if changes in a females carotenoid status are associated with changes in memory or thinking ability levels of inflammation and her infants 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
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 persons diet and changes in body composition We will study if changes in a females carotenoid status are associated with changes in memory or thinking ability levels of inflammation and her infants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3092-51000-061-002S | OTHER_GRANT | US Department of Agriculture Agricultural Research Service | None |