Child DevelopmentFLAVOURNCT03058523
Flavour Programming: Fruit and Vegetable Palatability
An observational study of Child Development, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women of Child bearing age
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, The Rowett Institute
Aberdeen, AB25 2ZD
About this study
Official title: Flavour Programming: Fruit and Vegetable Format Palatability
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.
Read the detailed description
Foods that tend to be rejected by children include those with the greatest importance for later health such as fruit and vegetables. Eating behaviour and acceptance of new tastes, textures and flavours in young children is influenced by a plethora of biological and environmental factors. Infants have an inborn preference for sweet and umami flavours and dislike sour and bitter, but there is evidence that sensory experiences beginning very early in development can positively modify these preferences in favour ultimately of healthier food choices. Babies are first exposed to flavour through swallowing amniotic fluid in utero and then later through breast or formula milk. There is evidence in a variety of species, including humans, to show that this can be manipulated particularly during late pregnancy to influence subsequent liking and consumption of individual foods with specific high intensity flavours potentially. However, there is a lack of 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 bitter taste. The hypothesis is that an intervention to increase maternal intake of fruit and vegetables in late pregnancy, in women who normally struggle to achieve their 5-a-day, 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 and designing the main study, investigators need to ensure that the component parts are feasible: central to this is evaluating the general acceptance and taste profile of the fruit and vegetable (F\&V) formats that it is intended to offer to the mothers.
A range of innovative presentation formats for a variety of the most pungent fruits and vegetables are currently being developed. These include soups, sauces, crispbreads, muffins and smoothies that incorporate vegetables and/or fruits that are generally considered as bitter or sour tasting. A recent scoping survey of women of childbearing age confirmed prior observations in both sexes that vegetables with a bitter profile are less preferred / more likely never to have been tried, compared with sweet varieties. The survey also revealed that vegetables were largely consumed cooked and as part of ain meals. Accordingly the F\&V formats to be evaluated are predominantly pre-cooked and designed to be warmed through in a microwave to avoid destruction and or leaching of flavour by over zealous cooking. Although the survey revealed low consumption of vegetables in smoothie form or as snacks, this may have been due to lack of easy availability and hence a number of these have been included to potentially increase diversity of dietary formats and flavour exposure.
This application is primarily a palatability trial to establish taste profile and general acceptability of the diverse F\&V presentation formats in two groups: non-pregnant women of childbearing age, followed by pregnant women. As the perception of taste (particularly bitter, sweet and umami) may vary between individuals depending on genetic variation in certain taste receptor genes, it is proposed to characterise the relevant genotypes in buccal samples and relate this to their habitual diet and F\&V preferences. The utility of a non-invasive sampling route for measuring expression of genes involved in taste perception will also be determined using tongue swabs as this is a desirable feature for potentially scrutinising any impact of the proposed intervention on the taste perception of mothers and their infants and also requires to be assessed ahead of the designing of the main intervention study.
- Conditions
- Child Development
- Keywords
- Flavour, Infants, Taste, Pregnancy, Programming, Fruit, Vegetables, Bitter profile, Food preferences
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Pregnant | 30 non-pregnant women of childbearing age | |
| Pregnant | 30 pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start21 Mar 2017
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Wallace, PhD, DSc, Principal investigator, University of Aberdeen, The Rowett Institute, United Kingdom, AB25 2ZD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058523
- Sponsor's protocol ID
- 2016/RINH/6 - Flavour
- Other IDs
- 16/LO/2238, 2-045-16
- Acronym
- FLAVOUR
- Status last verified
- Oct 2018
- First submitted
- 10 Jan 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavour Programming: Fruit and Vegetable Format Palatability
- ClinicalTrials.gov ID
- NCT03058523
- Acronym / sponsor ID
- FLAVOUR / 2016/RINH/6 - Flavour
- Conditions
- Child Development
- Keywords
- Flavour, Infants, Taste, Pregnancy, Programming, Fruit, Vegetables, Bitter profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Foods that tend to be rejected by children include those with the greatest importance for later health such as fruit and vegetables. Eating behaviour and acceptance of new tastes, textures and flavours in young children is influenced by a plethora of biological and environmental factors. Infants have an inborn preference for sweet and umami flavours and dislike sour and bitter, but there is evidence that sensory experiences beginning very early in development can positively modify these preferences in favour ultimately of healthier food choices. Babies are first exposed to flavour through swallowing amniotic fluid in utero and then later through breast or formula milk. There is evidence in a variety of species, including humans, to show that this can be manipulated particularly during late pregnancy to influence subsequent liking and consumption of individual foods with specific high intensity flavours potentially. However, there is a lack of 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 bitter taste. The hypothesis is that an intervention to increase maternal intake of fruit and vegetables in late pregnancy, in women who normally struggle to achieve their 5-a-day, 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 and designing the main study, investigators need to ensure that the component parts are feasible: central to this is evaluating the general acceptance and taste profile of the fruit and vegetable (F\&V) formats that it is intended to offer to the mothers.
A range of innovative presentation formats for a variety of the most pungent fruits and vegetables are currently being developed. These include soups, sauces, crispbreads, muffins and smoothies that incorporate vegetables and/or fruits that are generally considered as bitter or sour tasting. A recent scoping survey of women of childbearing age confirmed prior observations in both sexes that vegetables with a bitter profile are less preferred / more likely never to have been tried, compared with sweet varieties. The survey also revealed that vegetables were largely consumed cooked and as part of ain meals. Accordingly the F\&V formats to be evaluated are predominantly pre-cooked and designed to be warmed through in a microwave to avoid destruction and or leaching of flavour by over zealous cooking. Although the survey revealed low consumption of vegetables in smoothie form or as snacks, this may have been due to lack of easy availability and hence a number of these have been included to potentially increase diversity of dietary formats and flavour exposure.
This application is primarily a palatability trial to establish taste profile and general acceptability of the diverse F\&V presentation formats in two groups: non-pregnant women of childbearing age, followed by pregnant women. As the perception of taste (particularly bitter, sweet and umami) may vary between individuals depending on genetic variation in certain taste receptor genes, it is proposed to characterise the relevant genotypes in buccal samples and relate this to their habitual diet and F\&V preferences. The utility of a non-invasive sampling route for measuring expression of genes involved in taste perception will also be determined using tongue swabs as this is a desirable feature for potentially scrutinising any impact of the proposed intervention on the taste perception of mothers and their infants and also requires to be assessed ahead of the designing of the main intervention study.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Pregnant | – | –30 non-pregnant women of childbearing age |
| Pregnant | – | –30 pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women of Child bearing age
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palatability of defined foods using a nine point scale
Time frame: 9 months
The two taste sessions will be done between 1 and 10 days apart dependant on volunteer availability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Wallace, PhD, DSc principal investigator
University of Aberdeen, The Rowett Institute, United Kingdom, AB25 2ZD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability of defined foods using a nine point scale (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.