Food Sensory PerceptionNCT03219853
Investigating the Sensory Effects of Selenium-enriched Parsnips.
A study testing selenium enriched parsnips and Conventional parsnips in people with Food Sensory Perception and Selenium Status, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Study aims to investigate 2 topics: 1. Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be influenced by unconscious mechanisms which operate to ensure the safeguarding of individual nutrient levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Sensory Perception, Selenium Status
- What is being tested?
- selenium enriched parsnips and Conventional parsnips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2017to 14 Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults of either gender, aged over 18 years.
- Willingness and ability to provide blood samples, consume parsnips daily for 2 weeks, and carry out 2 sensory tests, as described in the Participant Information Sheet.
- Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.
Who cannot join
- Under 18 years.
- Difficulties with chewing or swallowing.
- Taste disorders.
- Allergies to parsnips.
- Impairments which may prevent mental understanding of trial, or informed consent from being given.
- Taking supplements providing more than 60µg Se per day
Show all 9Show fewer
- Initial analysed selenium status of less than 28μg/L.
- Initial analysed selenium status of over 400μg/L.
- Any other condition that in the view of the participant's General Practitioner (GP) may make the participant unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, NE17RU
Anthony W Watson, PhD, 01912083592, anthony.watson@ncl.ac.uk
Ailsa Marsh
About this study
Official title: Investigating Flavour-nutrient Learning in Humans Using Selenium-enriched Parsnips
Study aims to investigate 2 topics:
- Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be influenced by unconscious mechanisms which operate to ensure the safeguarding of individual nutrient levels. The theory postulates that food preferences may change over time to address changing nutritional status (Yeomans, 2012). This study aims to explore FNL in humans by investigating the preferences of participants with low and high blood-selenium levels in relation to selenium-enriched parsnips. Participants will be investigated in a two-week trial in which they will undertake two food sensory tests: one before, and one after, the two-week period where they will incorporate provided parsnips into their diet. Some provided parsnips will contain higher levels of selenium than others, neither the participants nor the lead researcher will know which type of parsnip each participant receives. It is hypothesised that the second food sensory test, performed after the intervention period, will show that participants of lower initial blood-selenium levels will demonstrate an increased liking for the selenium-enriched parsnips. This may demonstrate possible FNL in humans.
- Relationship between selenium intake \& plasma selenium-status. This study will also examine the relationship (if any) between the selenium intake of all participants via the different types of parsnips, and their individual blood-selenium levels.
Read more
This will be assessed via blood tests before, during and after the trial in order to observe the blood-selenium levels of each participant.
It is hypothesised that the blood-selenium levels of participants of lower initial selenium readings will be the most improved upon consumption of selenium-enriched parsnips.
Read the detailed description
- FNL Despite a wealth of animal studies (Amanoel et al, 2016; Bach et al, 2012), human FNL research is in relative infancy. This study intends to investigate FNL in humans by exploring preferences of participants of different selenium-status regarding selenium-enriched parsnips, with non-enriched parsnips and other root vegetables to be used as comparators. Participants will be assessed by means of food sensory tests and blood analysis before, during and after the trial period. The trial aims to recruit 26 lower selenium-status participants of initial selenium-status approx. 70μg/L, and 26 higher selenium-status participants of initial selenium-status approx. 100μg/L (n=52). (Initial screening sample approx. n=120.) On initial screening, potential participants recording a selenium-status of under 28μg/L or over 400μg/L will be excluded (and their GP informed) for safety reasons. Re parsnips: Selenium-enriched parsnips: Se content approx. 0.30ppm. Placebo comparator: non-selenium-enriched parsnips: Se content approx. 0.06ppm. Treatment portion: 200g fresh weight per day for 14 days. Comparator vegetables: potato, celeriac, turnip.
- Relationship between selenium intake \& plasma selenium-status. This study will also investigate the relationship, if any, between the selenium intake of all participants via the different types of parsnips and their individual selenium status. This will be assessed via blood tests before, during and after the trial in order to observe plasma-selenium status.
This is deemed an important area for research as research suggests a trend towards selenium deficiency in the United Kingdom population (SACN, 2013). It is hoped the current study may inform the debate regarding the potential of improving United Kingdom's population selenium status via selenium-fortified foods.
- Conditions
- Food Sensory Perception, Selenium Status
- Being tested
- selenium enriched parsnips, Conventional parsnips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenium enriched parsnipsDietary supplement
Parsnips which have been grown in a selenium enriched environment
Conventional parsnipsDietary supplement
Parsnips which have been grown in a conventional environment
| Study group | Role | What they receive |
|---|---|---|
| Lower selenium-status | Experimental | Not described Receives: Dietary Supplement: selenium enriched parsnips; Dietary Supplement: Conventional parsnips |
| higher selenium | Experimental | Not described Receives: Dietary Supplement: selenium enriched parsnips; Dietary Supplement: Conventional parsnips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food sensory perception
change from baseline sensory perception of food samples
Measured: Baseline & post 14 weeks supplementation
Secondary outcomes (1)
Selenium status
Change from baseline selenium status
Measured: Baseline, post 7 days supplementation ad post 14 days supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start22 Mar 2017
- Primary completion14 Dec 2017 (estimated)
- Study completion14 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Sensory PerceptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Fera Science, Institute For Agri-food Research and Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219853
- Sponsor's protocol ID
- NUHEALTH-AM01-SELENIUM
- Status last verified
- Nov 2017
- First submitted
- 21 Jun 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Flavour-nutrient Learning in Humans Using Selenium-enriched Parsnips
- ClinicalTrials.gov ID
- NCT03219853
- Acronym / sponsor ID
- NUHEALTH-AM01-SELENIUM
- Conditions
- Food Sensory Perception, Selenium Status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Fera Science, Institute For Agri-food Research and Innovation
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 14 Dec 2017 (estimated)
- Study completion
- 14 Dec 2017 (estimated)
- First posted
- 18 Jul 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.
Study aims to investigate 2 topics:
- Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be influenced by unconscious mechanisms which operate to ensure the safeguarding of individual nutrient levels. The theory postulates that food preferences may change over time to address changing nutritional status (Yeomans, 2012). This study aims to explore FNL in humans by investigating the preferences of participants with low and high blood-selenium levels in relation to selenium-enriched parsnips. Participants will be investigated in a two-week trial in which they will undertake two food sensory tests: one before, and one after, the two-week period where they will incorporate provided parsnips into their diet. Some provided parsnips will contain higher levels of selenium than others, neither the participants nor the lead researcher will know which type of parsnip each participant receives. It is hypothesised that the second food sensory test, performed after the intervention period, will show that participants of lower initial blood-selenium levels will demonstrate an increased liking for the selenium-enriched parsnips. This may demonstrate possible FNL in humans.
- Relationship between selenium intake \& plasma selenium-status. This study will also examine the relationship (if any) between the selenium intake of all participants via the different types of parsnips, and their individual blood-selenium levels.
This will be assessed via blood tests before, during and after the trial in order to observe the blood-selenium levels of each participant.
It is hypothesised that the blood-selenium levels of participants of lower initial selenium readings will be the most improved upon consumption of selenium-enriched parsnips.
Detailed description
- FNL Despite a wealth of animal studies (Amanoel et al, 2016; Bach et al, 2012), human FNL research is in relative infancy. This study intends to investigate FNL in humans by exploring preferences of participants of different selenium-status regarding selenium-enriched parsnips, with non-enriched parsnips and other root vegetables to be used as comparators. Participants will be assessed by means of food sensory tests and blood analysis before, during and after the trial period. The trial aims to recruit 26 lower selenium-status participants of initial selenium-status approx. 70μg/L, and 26 higher selenium-status participants of initial selenium-status approx. 100μg/L (n=52). (Initial screening sample approx. n=120.) On initial screening, potential participants recording a selenium-status of under 28μg/L or over 400μg/L will be excluded (and their GP informed) for safety reasons. Re parsnips: Selenium-enriched parsnips: Se content approx. 0.30ppm. Placebo comparator: non-selenium-enriched parsnips: Se content approx. 0.06ppm. Treatment portion: 200g fresh weight per day for 14 days. Comparator vegetables: potato, celeriac, turnip.
- Relationship between selenium intake \& plasma selenium-status. This study will also investigate the relationship, if any, between the selenium intake of all participants via the different types of parsnips and their individual selenium status. This will be assessed via blood tests before, during and after the trial in order to observe plasma-selenium status.
This is deemed an important area for research as research suggests a trend towards selenium deficiency in the United Kingdom population (SACN, 2013). It is hoped the current study may inform the debate regarding the potential of improving United Kingdom's population selenium status via selenium-fortified foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower selenium-status | Experimental | Dietary Supplement: selenium enriched parsnips, Dietary Supplement: Conventional parsnips |
| higher selenium | Experimental | Dietary Supplement: selenium enriched parsnips, Dietary Supplement: Conventional parsnips |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of either gender, aged over 18 years.
- Willingness and ability to provide blood samples, consume parsnips daily for 2 weeks, and carry out 2 sensory tests, as described in the Participant Information Sheet.
- Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.
Key exclusion criteria (9 listed)
- Under 18 years.
- Difficulties with chewing or swallowing.
- Taste disorders.
- Allergies to parsnips.
- Impairments which may prevent mental understanding of trial, or informed consent from being given.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium enriched parsnipsParsnips which have been grown in a selenium enriched environment | Dietary supplement | Lower selenium-status, higher selenium |
| Conventional parsnipsParsnips which have been grown in a conventional environment | Dietary supplement | Lower selenium-status, higher selenium |
Primary outcome
Food sensory perception
Time frame: Baseline & post 14 weeks supplementation
change from baseline sensory perception of food samples
1 secondary outcome
Selenium status
Time frame: Baseline, post 7 days supplementation ad post 14 days supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenium enriched parsnips and Conventional parsnips in people with Food Sensory Perception and Selenium Status, run by Newcastle University 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ailsa Marsh (0191 208 5852, A.Marsh2@newcastle.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food sensory perception (time frame: Baseline & post 14 weeks supplementation). 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 20 Nov 2017.