NCT03058523

Brief Summary

Infants have an inborn preference for sweet and umami flavours and dislike sour and bitter, but there is evidence that sensory experiences beginning early in development can modify these preferences in favour ultimately of healthier food choices. Babies are first exposed to flavour in utero and then later through breast/formula milk. This can be manipulated to influence liking and consumption of individual foods with specific high-intensity flavours postnatally. There are no prospective studies evaluating the impact of increasing maternal fruit and vegetable intake during late pregnancy on a child's subsequent acceptance of fruit and vegetables, particularly those with a sour/bitter taste. The hypothesis is that an intervention to increase maternal intake of fruit and vegetables in late pregnancy will enhance fetal flavour exposure and make infants more likely to accept a wide variety of fruit and vegetables in childhood. Before testing this hypothesis, the investigators need to evaluate the general acceptance and taste profile of the fruit and vegetable formats that we intend to offer to pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

January 10, 2017

Last Update Submit

October 15, 2018

Conditions

Keywords

FlavourInfantsTastePregnancyProgrammingFruitVegetablesBitter profileFood preferences

Outcome Measures

Primary Outcomes (1)

  • Palatability of defined foods using a nine point scale

    The two taste sessions will be done between 1 and 10 days apart dependant on volunteer availability

    9 months

Study Arms (2)

Non-Pregnant

30 non-pregnant women of childbearing age

Pregnant

30 pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women of Child bearing age

You may qualify if:

  • For the non-pregnant cohort: women of childbearing age with no major health issues and who currently struggle to meet the recommended 5 portions of fruit and vegetables per day.
  • For the pregnant cohort: women who are \>16 and \<32 weeks pregnant (with no major health issues) and who currently struggle to meet the recommended 5 portions of fruit and vegetables per day.

You may not qualify if:

  • Men and anyone who is unable to understand the participant information sheet and/or to speak, read or understand the English language (as the investigators do not have the resources to translate the materials)
  • Women with known food allergies/intolerances or who are smokers, vegetarians or vegans
  • Anyone using medication known to impact taste perception e.g. asthma inhalers
  • Anyone with a hormone imbalance or metabolic disease that impacts their ability to taste
  • Anyone with a history of an eating disorder
  • Pregnant women with a history of recurring miscarriage or a diagnosis of hyperemesis gravidarium (severe nausea and vomiting), gestational diabetes or gestational hypertension or any other major pregnancy complication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tongue and cheek cells from buccal swabs

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jacqueline Wallace, PhD, DSc

    University of Aberdeen, The Rowett Institute, United Kingdom, AB25 2ZD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

February 23, 2017

Study Start

March 21, 2017

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations