Maternal Carotenoids Across Pregnancy Study

NCT06004479 | Completed

• 2 other identifiers: H-467213092-51000-061-002S
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Nutrition; Pregnancy Related

Keywords

carotenoids; skin carotenoids; cognitive function; pregnancy nutrition; macular carotenoids

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• Skin Carotenoid Concentrations - 1st Trimester Equivalent

  1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant)

• Macular pigment optical density - 1st Trimester Equivalent

  1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant)

• Skin Carotenoid Concentrations - 2nd Trimester Equivalent

  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

  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

  3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)

Other Outcomes (22)

• Subjective memory function (MAC-Q Score) - 1st Trimester Equivalent

  1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation(Week 0 if non-pregnant)

• Subjective memory function (MAC-Q Score) - 2nd Trimester Equivalent

  2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant)

• Subjective memory function (MAC-Q Score) - 3rd Trimester Equivalent

  3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant)

Study Arms (2)

Pregnant

Adult females between 18-40 years old who have a confirmed pregnancy.

Other: Carotenoid Intake; Other: Serum carotenoid concentration

Non-pregnant

Adult females between 18-40 years old who do not have a confirmed pregnancy.

Other: Carotenoid Intake; Other: Serum carotenoid concentration

Interventions

Carotenoid Intake OTHER

Carotenoid intake assess by 24 hour dietary recalls

Non-pregnant; Pregnant

Serum carotenoid concentration OTHER

Serum total carotenoid concentration

Non-pregnant; Pregnant

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults are recruited from the community of the greater Houston, TX metropolitan area.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, human milk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: August 22, 2023
• Study Start: September 14, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)