Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03605446 |
| Other study ID # |
809 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2018 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
July 2018 |
| Source |
Newcastle University |
| Contact |
Anthony Watson, PhD |
| Phone |
01912086935 |
| Email |
anthony.watson[@]ncl.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
As part of the Protein for Life project, design rules have been established which outline the
processes which need to be considered when designing higher protein products. These design
rules have been used to create a range of exemplar higher protein biscuits. Consumer feedback
is needed to validate the set of design rules. This project will assess the consumer
acceptance of higher protein biscuits made from plant and animal based proteins.
Description:
The Protein for Life project was funded by the Research Councils UK 'Priming Food
Partnerships' initiative which is supported by four councils: Biotechnology and Biological
Sciences Research Council (BBSRC), Medical Research Council (MRC), Engineering and Physical
Sciences Research Council (EPSRC) and Economic and Social Research Council (ESRC). The
initiative supports pre-competitive research, with the aim of stimulating innovative research
and technological advances of relevance to the food industry. The project has five key
objectives related to the development and dissemination of guidelines for the formulation of
palatable, cost effective, higher-protein foods for an ageing population.
The population of the UK is aging, and it is estimated that by 2039 more than 43% of adults
will be aged over 60 (ONS 2015). One significant healthcare challenge associated with aging
is sarcopenia. This refers to the decline of skeletal muscle tissue with age (Walston, 2012),
and can affect physical functioning and quality of life. One reason older adults may lose
muscle more easily is due to a decrease in protein intake. The current recommended daily
intake of protein in the UK is 0.8g/kg body weight. However, this is an estimate for the
entire population, tends to be based on a few younger individuals to determine this
(Phillips, Chevalier, & Leidy, 2016). Studies which have used older adults to estimate
protein and amino acid requirements have suggested that protein requirements in an older
population may be well above the recommended daily intake (Rafii et al., 2015; Tang et al.,
2014). Despite this, older adults do not consume increased amounts of protein. The purpose of
this experiment is to explore the psychological mechanisms underlying the reduced intake of
protein in older populations.
As part of the Protein for Life project, design rules have been established which outline the
processes which need to be considered when designing higher protein products. These design
rules have been used to create a range of exemplar higher protein biscuits. Consumer feedback
is needed to validate the set of design rules. This project will assess the consumer
acceptance of higher protein biscuits made from plant and animal based proteins.
As set of design rules have been established which outline the processes which need to be
considered when designing higher protein products. These design rules have been used to
create a range of exemplar higher protein biscuits. Consumer feedback is needed to validate
the set of design rules.
Study Objective
The project will assess the consumer acceptance of 5 biscuits, each with differing protein
quantities and sources. The aim is to test the design rules created in the protein for life
project. Outcomes of the consumer testing will inform the project of the optimal protein
source (plant or animal) and quantity for consumer acceptance.
The purpose of the trial is to assess the organoleptic properties of 4 ready to eat higher
protein biscuits and one control in a healthy adult population aged 40+ years.
Methods
5 products have been developed by Campden BRI Ltd. Products have been created in a food safe
facility. All ingredients are Generally Regarded As Safe (GRAS) ingredients. Once produced a
full list of allergens and ingredients will be made available. Safety and storage analysis
certification will also be available.
1. Animal based protein biscuit containing 12% of total energy as protein (source of
protein animal (SA))
2. Plant based protein biscuit containing 12% of total energy as protein (source of protein
plant (SP))
3. Animal based protein biscuit containing 20% of total energy as protein (high protein
animal (HA))
4. Plant based protein biscuit containing 20% of total energy as protein (high protein
plant (HP))
5. A generic taste matched wheat based biscuit (control (C))
Study Outcomes
The products will be assessed for taste, mouth feel and appearance using comparative
profiling testing. Data will be recorded using a computerised questionnaire. The
questionnaire is internet based so is accessible at multiple sites.
Study design
Each participant will assess each type of product and two control foods twice per session
along with one training plate. The layout of the plates will be set as below. Plate order and
order of samples on each plate will be advised using a random order as to negate any
sequencing bias and samples will be given a randomised number for each plate.
Plate Sample order Training plate SA SP HA HP C Plate 1 SA SP HA HP C Plate 2 SP HA HP C S
Participants
Participants will be recruited from 4 sites, Newcastle University, Bristol University,
Aberdeen University and Sheffield University. All participants will be healthy free-living
adults. Participants will be recruited to ensure equal gender distribution with groups
separated into 40-54, 54-69 and 70+ for analysis. Up to 20 participants of each age group
will be required at each site.
