ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000825752

Ethics application status

Approved

Date submitted

3/06/2022

Date registered

10/06/2022

Date last updated

22/05/2023

Date data sharing statement initially provided

10/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ENERGY

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Inadequate nutrition

Obesity

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Diet and Nutrition

Obesity

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

A group pregravid women with no plans to conceive in the next 24 months will serve as the comparator.

Control group

Active

Outcomes

Primary outcome [1]

Supra-threshold sensitivity changes: 8-step method of limits forced choice task across sensory modalities (olfaction, gustation, vision, tactile). A composite supra-threshold sensitivity will be quantified by d'.

Timepoint [1]

Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment

Primary outcome [2]

Dietary intake changes: macronutrient intake from 4-day weighed food record. Participant responses on this battery will be transferred into daily energy intake (in kj) of different nutrient sources using FoodWorks (Xyris Software, Australia).

Timepoint [2]

Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment

Primary outcome [3]

Metabolic changes: Basal Metabolic Rate will be assessed by measuring carbon dioxide production and oxygen consumption during a 30-min period, using open-circuit indirect calorimetry (COSMED, Italy). For this test, participants will be asked to stay in a supine position, awake with minimal movements, in a thermo-neutral room (22-26°C).

Timepoint [3]

Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment

Secondary outcome [1]

Changes in supra-threshold sensitivity: 8-step method of limits forced choice task across sensory modalities (olfaction, gustation, vision, tactile). A composite supra-threshold sensitivity will be quantified by d'.

Timepoint [1]

Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment

Secondary outcome [2]

Dietary changes: macronutrient intake from 4-day weighed food record. Participant responses on this battery will be transferred into daily energy intake (in kj) of different nutrient sources using FoodWorks (Xyris Software, Australia).

Timepoint [2]

Secondary outcome [3]

Timepoint [3]

Secondary outcome [4]

Changes in intensity: Stimuli will be presented at concentrations 4 times higher than the population recognition threshold using the generalised Labelled Magnitude Scale (gLMS)

Timepoint [4]

Secondary outcome [5]

Changes in hedonic preference: Stimuli will be presented at concentrations 4 times higher than the population recognition threshold hedonic perception measured using the Labelled Affective Magnitude scale (LAMs).

Timepoint [5]

Secondary outcome [6]

Changes in ad libitum intake: participants will be presented with a buffet consisting of an equal number of carbohydrate, fat, and protein rich food items which participants can consume ad libitum. Intake of each item will be weighed and recorded, and the data will be transformed into dietary composition in % Energy.

Timepoint [6]

Secondary outcome [7]

Changes in dietary preference: Participants will also complete a computerised food-choice task. Each trial will present two food images side-by-side and participants will be asked to indicate their choice of food item within 3 seconds. Each participant’s probabilities of choosing foods associated with the three macronutrients will be computed.

Timepoint [7]

Secondary outcome [8]

Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Insulin will be measured via radioimmunoassay (Milliplex, USA).

Timepoint [8]

Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment

Secondary outcome [9]

Metabolic changes: Body mass index will be measured using height (measured in cm using a stadiometer) and weight (measured in kg using calibrated scales).

Timepoint [9]

Secondary outcome [10]

Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Ghrelin will be measured via radioimmunoassay (Milliplex, USA).

Timepoint [10]

Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment

Secondary outcome [11]

Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Glucose- dependent insulinotropic peptide will be measured via radioimmunoassay (Milliplex, USA).

Timepoint [11]

Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment

Eligibility

Key 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).

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The total sample size of =130 (65 pregnant women and 65 controls) is powered on previously reported metabolic measures across pregnancy for parallel-arm studies, with power at 0.80 and an attrition rate at 10%. Initial recruitment of 165 women contemplating pregnancy assumes that around 50% of participants will be conceive within 12 months and that we will be able to retain the majority (more than 75%) of women who conceive during this period. We will ensure that the composition of the control cohort (n=65) will be comparable in ethnicity, age, and socioeconomic status.
We will conduct a longitudinal data analysis using linear mixed models to assess changes in the response outcomes over time. Multivariate model will be used where comparing multiple outcomes. The model will be adjusted for age, ethnicity, and socioeconomic status. All tests will be two-sided at a 5% level of significance. Adjusted means and mean different will be reported with the 95% Confidence Interval (CI) and p value. Sensitivity analyses will be conducted using dichotomous groupings such as high vs low sensitivity, high vs low BMI, ethnicity (where sufficient cases reported). Baseline characteristics of participants will be summarised descriptively for the pregnancy and control cohorts. Continuous variables will be summarised by mean and standard deviation (SD) with missing data reported but excluded. Categorical data will be summarised as frequencies (n) and percentages (%).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/08/2023

Actual

Date of last participant enrolment

Anticipated

31/05/2024

Actual

Date of last data collection

Anticipated

1/05/2026

Actual

Sample size

Target

230

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Dunedin, Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Society of New Zealand

Address [1]

Marsden Fund
Royal Society Te Aparangi
11 Turnbull Street
Thorndon 6011
Wellington
NEW ZEALAND

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Ethics Committee (Health)

Ethics committee address [1]

University of Otago Ethics Committee
Scott/Shand House, 
90 St David's Street, 
Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/04/2022

Approval date [1]

06/05/2022

Ethics approval number [1]

H22/047

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mei Peng

Address

Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 034794052

Fax

[email protected]

Contact person for public queries

Name

Jessica McCormack

Address

Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 03 479 7566

Fax

[email protected]

Contact person for scientific queries

Name

Mei Peng

Address

Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 034794052

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified and anonymised data may be made available.
De-identified data may be included in published study results including, but not limited to, peer-reviewed publications, clinical trial registry websites, scientific meetings, and regulatory / marketing submissions.

When will data be available (start and end dates)?

Following publication, no end date.

Available to whom?

De-identified data will only be made available to New Zealand researchers on request made to the Principal Investigator detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific eligibility criteria by data custodians. Future use of de-identified data in New Zealand will be consented to by participants.

Available for what types of analyses?

Each application will be reviewed based on scientific quality and robustness of the proposed statistical analysis plan by the Principal Investigator and Trial Steering Committee.

How or where can data be obtained?

Access will be subject to approval of the Principal Investigator. Anonymised data collected in the study may be submitted to Otago University Research archive for the purpose of ensuring reproducibility, transparency, integrity and fidelity of our study design and analysis methods.

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
16290	Study protocol	Manuscript in preparation
16291	Informed consent form		384171-(Uploaded-03-06-2022-09-11-04)-Study-related document.docx
16292	Ethical approval		384171-(Uploaded-03-06-2022-09-12-28)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

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