Selenium StatusNCT03770676
Investigating the Sensory Attributes of Selenium-fortified Biscuits and Their Effects on Selenium-status
A study testing Selenium-fortified biscuits in people with Selenium Status, run by Newcastle University at 1 site in United Kingdom.
Trial summary
This intervention study will investigate the relationship between consumption of selenium-fortified biscuits fortified with selenium-enriched yeast (approximately 60mcg of selenium per day for 14 days) and both plasma selenium concentration and plasma selenoprotein P concentration in adult human volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Selenium Status
- What is being tested?
- Selenium-fortified biscuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2018to 15 Mar 2020
- 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
- Adult human volunteers, 18 years of age or older.
- Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.
- Upon tasting the screening biscuit, are confident they would be able to eat the specified amount every day for 14 consecutive days.
- No taste or smell disorders.
- No difficulties with chewing and/or swallowing.
- No intolerances and/or allergies to any of the test foods.
Show all 11Show fewer
- No impairments which may prevent mental understanding of the trial, or informed consent from being given.
- No disorders/medication that would make blood sampling dangerous to their health.
- Plasma selenium not lower than 28 µg/L or higher than 400 µg/L on analysis
- Participants need to be able to visit Newcastle University for the scheduled visits.
- Participants must have been living in the UK for at least 6 months.
Who cannot join
- Do not meet all requirements in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Flavour-nutrient Learning in Humans Using Novel-flavoured, Selenium-fortified Biscuits
This intervention study will investigate the relationship between consumption of selenium-fortified biscuits fortified with selenium-enriched yeast (approximately 60mcg of selenium per day for 14 days) and both plasma selenium concentration and plasma selenoprotein P concentration in adult human volunteers. It will also investigate how selenium-status may affect changes in sensory perception of the fortified biscuits when consumed for 7 and 14 consecutive days (Flavour-Nutrient Learning).
Read the detailed description
There are different forms of selenium supplementation which may be used to improve selenium-status, one being selenium-enriched yeast.
Selenium is an essential micronutrient consumed through food, however the selenium contents of foods is variable, and depends upon the soil the food has been grown in. The UK population may not consume enough selenium through their diet, due to selenium levels in British soil being low and the use of North American wheat flour being increasingly replaced with lower selenium European flour.
It is therefore relevant to explore the ability of selenium-enriched yeast to improve selenium status if initially low. It is also important to investigate if the sensory attributes of selenium-fortified foods are different to unfortified foods. Additionally, investigating Flavour-Nutrient Learning (how selenium-status might change sensory perception of selenium-rich foods) could improve understanding of food choices.
This study aims to investigate the following topics:
- The relationship between selenium intake (through selenium-fortified biscuits) and selenium-status.
- How selenium-status affects sensory perception of selenium-fortified biscuits (Flavour Nutrient Learning, FNL).
- Conditions
- Selenium Status
- Being tested
- Selenium-fortified biscuits
- Keywords
- Food sensory perception, Selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium-fortified biscuitsDietary supplement
Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.
| Study group | Role | What they receive |
|---|---|---|
| Flavour 1 | Experimental | Selenium-fortified biscuits These participants will be assigned to biscuit flavour 1. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits for 14 consecutive days at home, providing approximately 60 mcg selenium per day. Receives: Dietary Supplement: Selenium-fortified biscuits |
| Flavour 2 | Experimental | Selenium-fortified biscuits These participants will be assigned to biscuit flavour 2. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits biscuit for 14 consecutive days at home, providing approximately 60 mcg selenium per day. Receives: Dietary Supplement: Selenium-fortified biscuits |
| Flavour 3 | Experimental | Selenium-fortified biscuits These participants will be assigned to biscuit flavour 3. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits for 14 consecutive days at home, providing approximately 60 mcg selenium per day. Receives: Dietary Supplement: Selenium-fortified biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preference for the intervention flavour over two other test flavours and plain flavour, after 14 days of consumption of Se-fortified intervention-flavoured biscuits.
Participants score their intervention flavour (the test flavour they eat for 14 days), two test flavours (not eaten for 14 days) and plain flavour using a visual analogue scale anchored by "not very"/0 and "very"/100. They do this for liking of smell, taste, texture, aftertaste and pleasantness of the overall eating experience. This is repeated three times (three plates of biscuits) in one food sensory test. Each attribute for each plate will have a 'preference score' calculated, using the following equation:
Preference score = (score of intervention flavour) - (average score of other 3 flavours).
Preference scores are then averaged across the three plates.
Flavour preference change is calculated as the change in average flavour preference score from baseline (day 1 food sensory test) to after 14 days of intervention biscuit consumption at home (day 15 food sensory test):
Preference change = day 15 score - day 1 score
Measured: Day 1 (baseline) and day 15 (post-14 days of intervention biscuit consumption).
Secondary outcomes (12)
Change in preference for the intervention flavour over two other test flavours and plain flavour, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Preference scores for each day are calculated using the formula in the primary outcome measure. Preference change is calculated using the following formula:
Preference change = day 8 score - day 1 score
Measured: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in preference for the intervention flavour over two other test flavours, after 14 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Preference scores for each day are calculated using the formula in the primary outcome measure, except without including the scores of the plain flavour. Preference change is measured using the formula in the primary outcome measure.
Measured: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in preference for the intervention flavour over two other test flavours, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Preference scores for each day are calculated using the formula in the primary outcome measure, except without including the scores of the plain flavour. Preference change is measured using the formula in the second outcome measure.
Measured: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in preference for the intervention flavour over plain flavour, after 14 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Preference scores for each day are calculated using the formula in the primary outcome measure, except without including the scores of the two test flavour. Preference change is measured using the formula in the primary outcome measure.
Measured: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in preference for the intervention flavour compared with plain flavour, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Preference scores for each day are calculated using the formula in the primary outcome measure, except without including the scores of the two test flavours. Preference change is measured using the formula in the second outcome measure.
Measured: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 14 consecutive days.
Blood samples taken via venepuncture or finger-prick, centrifuged and plasma collected. Plasma analysed using inductively coupled plasma mass spectrometry (ICP-MS) after acid digestion.
Change in plasma selenium concentration = concentration at day 15 (post 14 days of intervention biscuit consumption) - concentration at day 1 (baseline).
Measured: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 7 consecutive days.
Blood samples taken via venepuncture or finger-prick, centrifuged and plasma collected. Plasma analysed using ICP-MS after acid digestion.
Change in plasma selenium concentration = concentration at day 8 (post 7 days of intervention biscuit consumption) - concentration at day 1 (baseline).
Measured: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in plasma selenoprotein P (SEPP1) concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 14 consecutive days.
Blood samples taken via venepuncture, centrifuged and plasma collected. Plasma analysed using ELISA.
Change in plasma selenoprotein P concentration = concentration at day 15 (post 14 days of intervention biscuit consumption) - concentration at day 1 (baseline).
Measured: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in plasma selenoprotein P (SEPP1) concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 7 consecutive days.
Blood samples taken via venepuncture, centrifuged and plasma collected. Plasma analysed using ELISA.
Change in plasma selenoprotein P concentration = concentration at day 8 (post 7 days of intervention biscuit consumption) - concentration at day 1 (baseline).
Measured: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
How many participants prefer a fortified test biscuit over an unfortified version of their intervention biscuit in a paired comparison test?
Participants are asked to indicate which they prefer from two biscuits on a plate. One biscuit will be a selenium-fortified test biscuit, and the other an unfortified version of their intervention biscuit. This is to test if preference is stronger for the intervention flavour or the Se-enriched yeast.
Measured: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
How many participants prefer a fortified test biscuit over an unfortified test biscuit of a different flavour in a paired comparison test?
Participants are asked to indicate which they prefer from two biscuits on a plate. The biscuits will be the participant's two test flavours, one of which will be fortified. This is to test if a preference has developed for Se-enriched yeast flavour.
Measured: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
How many participants prefer their fortified intervention biscuit over an unfortified test biscuit in a paired comparison test?
Participants are asked to indicate which they prefer from two biscuits on a plate. The biscuits will be the participant's fortified intervention biscuit, and an unfortified test biscuits. This is to test if participants prefer their intervention biscuit.
Measured: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start3 Dec 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selenium StatusStudies 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
- Model description
- There are three study groups (three 'test' biscuit flavours). Each study group will be assigned one test flavour ('intervention' flavour/biscuit). They begin consumption of their intervention biscuits on day 1 and finish on day 14. Plasma selenium concentration and sensory perception of biscuits will be measured on day 1 (baseline), 8 (post-7 days of intervention) and 15 (post-14 days of intervention).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Fera Science Ltd.
- Responsible party
- Sponsor
- Investigators
- Kirsten Brandt, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770676
- Sponsor's protocol ID
- 1533/4994/2018
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2018
- Last updated
- 18 Jan 2022
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Flavour-nutrient Learning in Humans Using Novel-flavoured, Selenium-fortified Biscuits
- ClinicalTrials.gov ID
- NCT03770676
- Acronym / sponsor ID
- 1533/4994/2018
- Conditions
- Selenium Status
- Keywords
- Food sensory perception, Selenium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Fera Science Ltd.
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 10 Dec 2018 (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.
This intervention study will investigate the relationship between consumption of selenium-fortified biscuits fortified with selenium-enriched yeast (approximately 60mcg of selenium per day for 14 days) and both plasma selenium concentration and plasma selenoprotein P concentration in adult human volunteers. It will also investigate how selenium-status may affect changes in sensory perception of the fortified biscuits when consumed for 7 and 14 consecutive days (Flavour-Nutrient Learning).
Detailed description
There are different forms of selenium supplementation which may be used to improve selenium-status, one being selenium-enriched yeast.
Selenium is an essential micronutrient consumed through food, however the selenium contents of foods is variable, and depends upon the soil the food has been grown in. The UK population may not consume enough selenium through their diet, due to selenium levels in British soil being low and the use of North American wheat flour being increasingly replaced with lower selenium European flour.
It is therefore relevant to explore the ability of selenium-enriched yeast to improve selenium status if initially low. It is also important to investigate if the sensory attributes of selenium-fortified foods are different to unfortified foods. Additionally, investigating Flavour-Nutrient Learning (how selenium-status might change sensory perception of selenium-rich foods) could improve understanding of food choices.
This study aims to investigate the following topics:
- The relationship between selenium intake (through selenium-fortified biscuits) and selenium-status.
- How selenium-status affects sensory perception of selenium-fortified biscuits (Flavour Nutrient Learning, FNL).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- There are three study groups (three 'test' biscuit flavours). Each study group will be assigned one test flavour ('intervention' flavour/biscuit). They begin consumption of their intervention biscuits on day 1 and finish on day 14. Plasma selenium concentration and sensory perception of biscuits will be measured on day 1 (baseline), 8 (post-7 days of intervention) and 15 (post-14 days of intervention).
| Arm | Type | Receives |
|---|---|---|
| Flavour 1 | Experimental | Dietary Supplement: Selenium-fortified biscuitsSelenium-fortified biscuits These participants will be assigned to biscuit flavour 1. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits for 14 consecutive days at home, providing approximately 60 mcg selenium per day. |
| Flavour 2 | Experimental | Dietary Supplement: Selenium-fortified biscuitsSelenium-fortified biscuits These participants will be assigned to biscuit flavour 2. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits biscuit for 14 consecutive days at home, providing approximately 60 mcg selenium per day. |
| Flavour 3 | Experimental | Dietary Supplement: Selenium-fortified biscuitsSelenium-fortified biscuits These participants will be assigned to biscuit flavour 3. If possible, there will be an equal number of low, medium and high selenium-status participants. They will consume this flavour of selenium-fortified biscuits for 14 consecutive days at home, providing approximately 60 mcg selenium per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult human volunteers, 18 years of age or older.
- Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.
- Upon tasting the screening biscuit, are confident they would be able to eat the specified amount every day for 14 consecutive days.
- No taste or smell disorders.
- No difficulties with chewing and/or swallowing.
Key exclusion criteria (1 listed)
- Do not meet all requirements in the inclusion criteria.
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-fortified biscuitsSelenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours. | Dietary supplement | Flavour 1, Flavour 2, Flavour 3 |
Primary outcome
Change in preference for the intervention flavour over two other test flavours and plain flavour, after 14 days of consumption of Se-fortified intervention-flavoured biscuits.
Time frame: Day 1 (baseline) and day 15 (post-14 days of intervention biscuit consumption).
Participants score their intervention flavour (the test flavour they eat for 14 days), two test flavours (not eaten for 14 days) and plain flavour using a visual analogue scale anchored by "not very"/0 and "very"/100. They do this for liking of smell, taste, texture, aftertaste and pleasantness of the overall eating experience. This is repeated three times (three plates of biscuits) in one food sensory test. Each attribute for each plate will have a 'preference score' calculated, using the following equation: Preference score = (score of intervention flavour) - (average score of other 3 flavours). Preference scores are then averaged across the three plates. Flavour preference change is calculated as the change in average flavour preference score from baseline (day 1 food sensory test) to after 14 days of intervention biscuit consumption at home (day 15 food sensory test): Preference change = day 15 score - day 1 score
12 secondary outcomes
Change in preference for the intervention flavour over two other test flavours and plain flavour, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Time frame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in preference for the intervention flavour over two other test flavours, after 14 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Time frame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in preference for the intervention flavour over two other test flavours, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Time frame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in preference for the intervention flavour over plain flavour, after 14 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Time frame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in preference for the intervention flavour compared with plain flavour, after 7 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
Time frame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 14 consecutive days.
Time frame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 7 consecutive days.
Time frame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
Change in plasma selenoprotein P (SEPP1) concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 14 consecutive days.
Time frame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
Change in plasma selenoprotein P (SEPP1) concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 7 consecutive days.
Time frame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
How many participants prefer a fortified test biscuit over an unfortified version of their intervention biscuit in a paired comparison test?
Time frame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
How many participants prefer a fortified test biscuit over an unfortified test biscuit of a different flavour in a paired comparison test?
Time frame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
How many participants prefer their fortified intervention biscuit over an unfortified test biscuit in a paired comparison test?
Time frame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
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 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
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.
Kirsten Brandt, PhD principal investigator
Newcastle University
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-fortified biscuits in people with 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 11 inclusion and 1 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 18 Jan 2022. 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?
Change in preference for the intervention flavour over two other test flavours and plain flavour, after 14 days of consumption of Se-fortified intervention-flavoured biscuits. (time frame: Day 1 (baseline) and day 15 (post-14 days of intervention biscuit consumption).). 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 18 Jan 2022.