Acceptance, SocialProtein4LifeNCT03605446
Protein for Life: Towards a Focused Dietary Framework for Healthy Ageing. Consumer Assessment of High Protein Biscuits
A study testing Biscuit acceptance in people with Acceptance, Social, run by Newcastle University at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acceptance, Social
- What is being tested?
- Biscuit acceptance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Jul 2018to 31 Dec 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
No allergies to any food Aged over 40
Trial locations and contacts
3 sites in 1 country.
Emma Stevenson, Prof contact
United Kingdom3 sites
The Rowett Institute
Aberdeen, Aberdeenshire, AB25 2ZD
Alexandra Johnstone, Prof, +44 (0)1224 438614, Alex.Johnstone@abdn.ac.uk
Bristol University
Bristol, BS8 1TU
Jeff Brunstrom, Proff, +44 (0) 117 928 8574, jeff.brunstrom@bristol.ac.uk
Department of Oncology & Metabolism, University of Sheffield
Sheffield, S10 2RX
Elizabeth Williams, Dr, +44 (0)114 215 9065, e.a.williams@sheffield.ac.uk
Bernard Corfe, Dr, +44 (0)114 215 9044, b.m.corfe@sheffield.ac.uk
About this study
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.
Read the detailed 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.
- Animal based protein biscuit containing 12% of total energy as protein (source of protein animal (SA))
- Plant based protein biscuit containing 12% of total energy as protein (source of protein plant (SP))
- Animal based protein biscuit containing 20% of total energy as protein (high protein animal (HA))
- Plant based protein biscuit containing 20% of total energy as protein (high protein plant (HP))
- 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.
- Conditions
- Acceptance, Social
- Being tested
- Biscuit acceptance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biscuit acceptanceDietary supplement
Acceptance of high protein biscuits
| Study group | Role | What they receive |
|---|---|---|
| Animal 12% | Experimental | Animal based protein biscuit containing 12% of total energy as protein Receives: Dietary Supplement: Biscuit acceptance |
| Animal 20% | Experimental | Animal based protein biscuit containing 20% of total energy as protein Receives: Dietary Supplement: Biscuit acceptance |
| Plant 12% | Experimental | Plant based protein biscuit containing 12% of total energy as protein Receives: Dietary Supplement: Biscuit acceptance |
| Plant 20% | Experimental | Plant based protein biscuit containing 20% of total energy as protein Receives: Dietary Supplement: Biscuit acceptance |
| Wheat biscuit | Placebo comparator | Not described Receives: Dietary Supplement: Biscuit acceptance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste as assessed by consumer taste panel
Acceptance of taste
Measured: Baseline
Mouth feel as assessed by consumer taste panel
Acceptance of mouth feel
Measured: Baseline
Appearance as assessed by consumer taste panel
Acceptance of mouth feel
Measured: Baseline
Expected satiety as assessed by consumer taste panel
Expected satiety from consuming test biscuits
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start30 Jul 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance, SocialStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen, University of Bristol, University of Liverpool
- Responsible party
- Principal investigator, Anthony Watson, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605446
- Sponsor's protocol ID
- 809
- Acronym
- Protein4Life
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein for Life: Towards a Focused Dietary Framework for Healthy Ageing. Consumer Assessment of High Protein Biscuits
- ClinicalTrials.gov ID
- NCT03605446
- Acronym / sponsor ID
- Protein4Life / 809
- Conditions
- Acceptance, Social
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- University of Aberdeen, University of Bristol, University of Liverpool
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 30 Jul 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.
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.
Detailed 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.
- Animal based protein biscuit containing 12% of total energy as protein (source of protein animal (SA))
- Plant based protein biscuit containing 12% of total energy as protein (source of protein plant (SP))
- Animal based protein biscuit containing 20% of total energy as protein (high protein animal (HA))
- Plant based protein biscuit containing 20% of total energy as protein (high protein plant (HP))
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Animal 12% | Experimental | Dietary Supplement: Biscuit acceptanceAnimal based protein biscuit containing 12% of total energy as protein |
| Animal 20% | Experimental | Dietary Supplement: Biscuit acceptanceAnimal based protein biscuit containing 20% of total energy as protein |
| Plant 12% | Experimental | Dietary Supplement: Biscuit acceptancePlant based protein biscuit containing 12% of total energy as protein |
| Plant 20% | Experimental | Dietary Supplement: Biscuit acceptancePlant based protein biscuit containing 20% of total energy as protein |
| Wheat biscuit | Placebo comparator | Dietary Supplement: Biscuit acceptance |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Biscuit acceptanceAcceptance of high protein biscuits | Dietary supplement | Animal 12%, Animal 20%, Plant 12%, Plant 20%, Wheat biscuit |
Primary outcome
Taste as assessed by consumer taste panel
Time frame: Baseline
Acceptance of taste
Mouth feel as assessed by consumer taste panel
Time frame: Baseline
Acceptance of mouth feel
Appearance as assessed by consumer taste panel
Time frame: Baseline
Acceptance of mouth feel
Expected satiety as assessed by consumer taste panel
Time frame: Baseline
Expected satiety from consuming test biscuits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Related trials for Acceptance, Social
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
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.
Emma Stevenson, Prof contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biscuit acceptance in people with Acceptance, Social, run by Newcastle University at 3 sites 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?
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: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Watson, PhD (01912086935, anthony.watson@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste as assessed by consumer taste panel (time frame: Baseline). The study lists 4 primary outcomes in all. 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 30 Jul 2018.