Energy, Neurosensory and Eating Responses durinG pregnancY (ENERGY cohort)

How do sensory shifts shape our diet? - Testing the neural mechanisms underpinning nutrient selection in adult women who are and are not planning to conceive

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12622000825752

Acronym

ENERGY

Enrollment

230

Registered

2022-06-10

Start date

2023-08-11

Completion date

2024-05-31

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We are conducting a longitudinal prospective cohort of never pregnant women in order to understand neurosensory changes over the reproductive cycle (from pre-pregnancy to post-pregnancy) interact with diet and metabolism. The study will compare women who become pregnant to an age and BMI matched control group of women who do not become pregnant. The aim of the study is to identify the neural and sensory mechanisms that determine micronutrient selection during metabolic reprogramming (i.e., pregnancy). Understanding how these changes interact during pregnancy will help us to better understand changes in diet and metabolism across the lifespan.

Interventions

The study is a prospective longitudinal study that will follow pregravid women (women who have not experienced pregnancy) for up two years. The study recruit a group of women planing to conceive and test for changes in diet, neurosensory responses, and metabolisms across the reproductive cycle - from pre-pregnancy, through pregnancy, and up to 1-year post-pregnancy. The following questionnaires and assessments will be used throughout the study: - Demographic Information (Baseline (study entry) 1 only) - Study-specific questionnaire on reproductive history, diet, and other health related beahviours (Baseline (study entry) 1 only) - Food Craving Inventory; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Dutch Eating Behaviour Questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Global Physical Activity Questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Hospital Anxiety and Depression Scale; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Study-specific pregnancy health questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Suprathreshold sensory tests; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Intensity and hedonic perception using standard scaling methods; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Anthropometric measures (including height, weight, skinfold thickness); Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Basal metabolic rate (via open-circuit indirect calorimetry); Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Blood samples; Baseline (study entry) and 1-year post-pregnancy (Pregnancy Cohort) or 21-months post-enrolment (Control Cohort) - Ad libitum intake from a buffet; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Dietary preference two-alternative forced choice task; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment - Four-day food record; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment Questionnaires can be completed online and will take around 15-30 minutes. Sensory assessments and physiological tests will take place face-to-face at the University of Otago Food Science Sensory Lab over four consecutive days, each taking 1-2 hours. The assessments will be conducted by trained research staff.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

• Women • 18-45 years • No previous pregnancy beyond 20 weeks • No history of neurological disease or metabolic conditions • No known sensory dysfunctions. Women planning to conceive within the next 12 months will be assigned to the Pregnancy Cohort (PC) and women with no short-term plans for conception (i.e., do not plan to conceive within the next 24 months) will be assigned to the Control Cohort (CC).

Exclusion criteria

Women will be excluded if they are currently pregnant or taking oral contraception. Participants will be excluded if they have had gender affirming surgery or hormone treatment procedures.

Outcome results