- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770676
Investigating the Sensory Attributes of Selenium-fortified Biscuits and Their Effects on Selenium-status
Investigating Flavour-nutrient Learning in Humans Using Novel-flavoured, Selenium-fortified Biscuits
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne & Wear
-
Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 7RU
- NU-Food
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
Do not meet all requirements in the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Flavour 1
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.
|
Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx.
60 mcg selenium per day, for 14 days).
One of three novel flavours.
|
EXPERIMENTAL: Flavour 2
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.
|
Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx.
60 mcg selenium per day, for 14 days).
One of three novel flavours.
|
EXPERIMENTAL: Flavour 3
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.
|
Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx.
60 mcg selenium per day, for 14 days).
One of three novel flavours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Day 1 (baseline) and day 15 (post-14 days of intervention biscuit consumption).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 |
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
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).
|
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). |
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).
|
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). |
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).
|
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). |
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).
|
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). |
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsten Brandt, PhD, Newcastle University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1533/4994/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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