Maternal Carotenoids Across Pregnancy Study

Pregnancy Related Clinical Trial

— MCAPS  

Official title:

Effect of Pregnancy and Lactation on Carotenoid Status and Bioactivity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06004479
• Other study ID #: H-46721
• Secondary ID: 3092-51000-061-0
• Status: Active, not recruiting
• Start date: September 14, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

• 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:

• 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).

• 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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Carotenoid Intake
Carotenoid intake assess by 24 hour dietary recalls
• Serum carotenoid concentration
Serum total carotenoid concentration

Locations

Country	Name	City	State
United States	USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective memory function (MAC-Q Score) - 1st Trimester Equivalent	Subjective memory function assessed by MAC-Q	1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation(Week 0 if non-pregnant)
Other	Subjective memory function (MAC-Q Score) - 2nd Trimester Equivalent	Subjective memory function assessed by MAC-Q	2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Other	Subjective memory function (MAC-Q Score) - 3rd Trimester Equivalent	Subjective memory function assessed by MAC-Q	3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Other	Subjective memory function (MAC-Q Score) - Post-partum Equivalent	Subjective memory function assessed by MAC-Q	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Other	Serum IL-6 - 1st Trimester Equivalent	Serum concentrations of IL-6	1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)
Other	Serum IL-6 - 2nd Trimester Equivalent	Serum concentrations of IL-6	2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Other	Serum IL-6 - 3rd Trimester Equivalent	Serum concentrations of IL-6	3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
Other	Serum IL-6 - Postpartum Equivalent	Serum concentrations of IL-6	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Other	Serum hsCRP - 1st Trimester Equivalent	Serum concentrations of high sensitivity C-reactive protein	1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
Other	Serum hsCRP - 2nd Trimester Equivalent	Serum concentrations of high sensitivity C-reactive protein	2nd Trimester Equivalent: 22w0d-23w6d gestation (or week 11-12 if non-pregnant)
Other	Serum hsCRP - 3rd Trimester Equivalent	Serum concentrations of high sensitivity C-reactive protein	3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
Other	Serum hsCRP - Postpartum Equivalent	Serum concentrations of high sensitivity C-reactive protein	Post-partum Equivalent: 7 weeks 0 days-8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Other	Serum sTNFr-II - 1st Trimester Equivalent	Serum concentrations of sTNFr-II	1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
Other	Serum sTNFr-II - 2nd Trimester Equivalent	Serum concentrations of sTNFr-II	2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Other	Serum sTNFr-II - 3rd Trimester Equivalent	Serum concentrations of sTNFr-II	3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant)
Other	Serum sTNFr-II - Post-partum Equivalent	Serum concentrations of sTNFr-II	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Other	Serum TNF-alpha- 1st Trimester Equivalent	Serum concentrations of sTNF-alpha	1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)
Other	Serum TNF-alpha- 2nd Trimester Equivalent	Serum concentrations of sTNF-alpha	2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Other	Serum TNF-alpha- 3rd Trimester Equivalent	Serum concentrations of sTNF-alpha	3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days gestation (week 22-23 if non-pregnant)
Other	Serum TNF-alpha- Post-partum Equivalent	Serum concentrations of sTNF-alpha	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Other	Infant serum carotenoid concentration	Serum total carotenoid concentration in 7-8 week old infants	7 weeks 0 days - 8 weeks 6 days post-partum
Other	Infant serum carotenoid concentration	Serum total carotenoid concentration in 7-8 week old infants	Post-partum: 7 weeks 0 days - 8 weeks 6 days post-partum
Primary	Serum Total Carotenoid Concentrations - 1st Trimester Equivalent	Sum of all major carotenoid species in serum collected from fasting participant.	1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant)
Primary	Serum Total Carotenoid Concentrations - 2nd Trimester Equivalent	Sum of all major carotenoid species in serum collected from fasting participant.	2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Primary	Serum Total Carotenoid Concentrations - 3rd Trimester Equivalent	Sum of all major carotenoid species in serum collected from fasting participant.	3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Primary	Serum Total Carotenoid Concentrations - Post-partum	Sum of all major carotenoid species in serum collected from fasting participant.	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Secondary	Skin Carotenoid Concentrations - 1st Trimester Equivalent	Skin carotenoid score measured by pressure-mediated reflection spectroscopy	1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)
Secondary	Macular pigment optical density - 1st Trimester Equivalent	Macular pigment optical density measured by heterochromatic flicker photometry	1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)
Secondary	Skin Carotenoid Concentrations - 2nd Trimester Equivalent	Skin carotenoid score measured by pressure-mediated reflection spectroscopy	2nd Trimester Equivalent: 22 weeks 0d - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Secondary	Macular pigment optical density - 2nd Trimester Equivalent	Macular pigment optical density measured by heterochromatic flicker photometry	2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)
Secondary	Skin Carotenoid Concentrations - 3rd Trimester Equivalent	Skin carotenoid score measured by pressure-mediated reflection spectroscopy	3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Secondary	Macular pigment optical density - 3rd Trimester Equivalent	Macular pigment optical density measured by heterochromatic flicker photometry	3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)
Secondary	Skin Carotenoid Concentrations - Post-partum Equivalent	Skin carotenoid score measured by pressure-mediated reflection spectroscopy	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)
Secondary	Macular pigment optical density - Post-partum Equivalent	Macular pigment optical density measured by heterochromatic flicker photometry	Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant)

External Links

•   Study Webpage and Study Interest Form