Effects of Increased Maternal Choline Intake on Child Cognitive Development

NCT04987099 | Active Not Recruiting

• 1 other identifier: 1911009219
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.

Conditions

Pregnancy

Keywords

Choline; Prenatal Supplementation; Pregnancy; Offspring Cognition; Offspring Emotion Regulation

Outcome Measures

Primary Outcomes (5)

• The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score

  The composite novelty score (proportion of looking to the novel image) is obtained from a series of 9 visual paired comparison tests. The novelty score is a measure of visual recognition memory for infants and has been shown to predict cognitive outcomes in childhood. This analysis will assess developmental trajectories for performance on this task across the first year of life (ages 5, 7, 10, and 13 months).

  Infant ages of 5, 7, 10, and 13 months

• The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score

  Visual attention orienting speed is measured by the latency to initiate a stimulus-guided fixation shift to a peripheral visual target (mean of up to 20 target presentations). The orienting score is found to be sensitive to maternal choline supplementation in infants of this age and has shown acceptable test-retest reliability and prediction of attention, memory, and intelligence quotient outcomes in childhood. This analysis will assess the within-subject age-adjusted mean saccade latency obtained from tests repeated at ages 5, 7, 10, and 13 months.

  Infant ages of 5, 7, 10, and 13 months

• The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score

  Sustained focused attention is measured during a 5-minute period in which infants are engaged in solitary play with a complex toy. The score is the average duration of infant engagement in a state of focused attention on the toy. Infants who sustain focused attention for longer durations have been found to have fewer attentional problems as children. This analysis will assess the within-subject age-adjusted mean duration of focused attention obtained from tests repeated at ages 5, 7, 10, and 13 months.

  Infant ages of 5, 7, 10, and 13 months

• The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores

  Negative affect in response to goal blockage is measured by coding of infant facial expression, vocalization, and body language over the course of four sequential task trials to produce composite scores of negative affect. Infants' ability to regulate negative affect during the task has been found to predict aggressiveness at age three and has been associated with non-compliance in toddlerhood.

  Infant ages of 7, 10, and 13 months

• The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores

  Infant negative affect in response to a violation of social expectations for interactions with a parent (the parent not engaging with infant's social cues and maintaining a neutral expression) is measured by coding of infant negative vocalizations (crying, screaming, etc.) over the course of three sequential task trials to produce composite scores of negative affect. Infants' behavior in this task has been shown to predict later attachment, internalizing, and externalizing behaviors in toddlerhood and early childhood.

  Infant ages of 7, 10, and 13 months

Study Arms (2)

Experimental Dose

EXPERIMENTAL

Participants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy.

Dietary Supplement: 550 mg/day Choline

Control Dose

PLACEBO COMPARATOR

Participants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy.

Dietary Supplement: 25 mg/day Choline

Interventions

550 mg/day Choline DIETARY_SUPPLEMENT

Choline chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.

Experimental Dose

25 mg/day Choline DIETARY_SUPPLEMENT

Choline chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.

Control Dose

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Singleton pregnancy (carrying one baby)
• years old
• Between 12-18 weeks pregnant at the time of screening
• Self-reported BMI \<35.0 in the three months prior to pregnancy (estimated or known)
• Willingness to comply with all study procedures for the duration of the study
• Intending to live in Ithaca, NY or the surrounding area for the duration of the study
• Intending to deliver at Cayuga Medical Center

You may not qualify if:

• Self-reported history of health conditions associated with metabolic or gastrointestinal function or adverse child outcomes
• Current use of medications known to affect liver or kidney function or child outcomes
• High omega-3 fatty acid intakes from diet (as determined by a licensed registered dietitian) at screening
• Choline supplementation that exceeds 50 mg/day at screening
• Use of alcohol, tobacco products, or recreational drugs during pregnancy or during the Prenatal Phase of the study
• Use of non-study approved or provided supplements during the Prenatal Phase of the study
• Development of pregnancy-related complications during the study (i.e. gestational diabetes, gestational hypertension, preeclampsia, genetic abnormalities, or miscarriage)

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14850, United States

Location

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Barbara J Strupp, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only a Laboratory Manager, who will label the supplements with participant ID, will have access to participants' study assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: August 3, 2021
• Study Start: December 13, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)