Clinical trial NCT03770676: Investigating the Sensory Attributes of Selenium-fortified Biscuits and Their Effects on Selenium-status
Official title: Investigating Flavour-nutrient Learning in Humans Using Novel-flavoured, Selenium-fortified Biscuits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Selenium Status
Keywords: Food sensory perception
Selenium
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Fera Science Ltd.
First posted: 2018-12-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: BASIC_SCIENCE

Brief 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. 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:

1. The relationship between selenium intake (through selenium-fortified biscuits) and selenium-status.
2. How selenium-status affects sensory perception of selenium-fortified biscuits (Flavour Nutrient Learning, FNL).

Eligibility criteria: Inclusion Criteria:

1. Adult human volunteers, 18 years of age or older.
2. Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.
3. Upon tasting the screening biscuit, are confident they would be able to eat the specified amount every day for 14 consecutive days.
4. No taste or smell disorders.
5. No difficulties with chewing and/or swallowing.
6. No intolerances and/or allergies to any of the test foods.
7. No impairments which may prevent mental understanding of the trial, or informed consent from being given.
8. No disorders/medication that would make blood sampling dangerous to their health.
9. Plasma selenium not lower than 28 µg/L or higher than 400 µg/L on analysis
10. Participants need to be able to visit Newcastle University for the scheduled visits.
11. Participants must have been living in the UK for at least 6 months.

Exclusion Criteria:

Do not meet all requirements in the inclusion criteria.

Primary outcomes:
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.
timeFrame: Day 1 (baseline) and day 15 (post-14 days of intervention biscuit consumption).
Secondary outcomes:
measure: 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.
timeFrame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
measure: 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.
timeFrame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
measure: 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.
timeFrame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
measure: Change in preference for the intervention flavour over plain flavour, after 14 days of consumption of Se-fortified biscuits flavoured with the intervention flavour.
timeFrame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
measure: 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.
timeFrame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
measure: Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 14 consecutive days.
timeFrame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
measure: Change in plasma selenium concentration after consumption of selenium-fortified biscuits (approximately 60 micrograms of selenium per day) daily for 7 consecutive days.
timeFrame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
measure: 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.
timeFrame: Day 1 (baseline) and day 15 (post 14 days of intervention biscuit consumption).
measure: 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.
timeFrame: Day 1 (baseline) and day 8 (post 7 days of intervention biscuit consumption).
measure: How many participants prefer a fortified test biscuit over an unfortified version of their intervention biscuit in a paired comparison test?
timeFrame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
measure: How many participants prefer a fortified test biscuit over an unfortified test biscuit of a different flavour in a paired comparison test?
timeFrame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
measure: How many participants prefer their fortified intervention biscuit over an unfortified test biscuit in a paired comparison test?
timeFrame: Day 1 (baseline), day 8 (post-7 days intervention) and day 15 (post-14 days intervention).
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: NU-Food
state: Tyne & Wear
Study officials:
affiliation: Newcastle University
name: Kirsten Brandt, PhD
role: PRINCIPAL_INVESTIGATOR
References: