Investigating the Sensory Attributes of Selenium-fortified Biscuits and Their Effects on Selenium-status

NCT ID: NCT03770676

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2020-03-15

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).

Conditions

Selenium Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Selenium-fortified biscuits

Intervention Type: DIETARY_SUPPLEMENT

Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.

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.

Group Type: EXPERIMENTAL

Selenium-fortified biscuits

Intervention Type: DIETARY_SUPPLEMENT

Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.

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.

Group Type: EXPERIMENTAL

Selenium-fortified biscuits

Intervention Type: DIETARY_SUPPLEMENT

Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.

Interventions

Selenium-fortified biscuits

Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fera Science Ltd.

UNKNOWN

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Brandt, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

NU-Food

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

1533/4994/2018

Identifier Type: -

Identifier Source: org_study_id