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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Anthony Watson, PhD contact

01912086935

anthony.watson@ncl.ac.uk

Emma Stevenson, Prof contact

Emma.stevenson@ncl.ac.uk

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

Other trials in United Kingdom

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.

  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.

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 groups in NCT03605446
Study groupRoleWhat they receive
Animal 12%ExperimentalAnimal based protein biscuit containing 12% of total energy as protein
Receives: Dietary Supplement: Biscuit acceptance
Animal 20%ExperimentalAnimal based protein biscuit containing 20% of total energy as protein
Receives: Dietary Supplement: Biscuit acceptance
Plant 12%ExperimentalPlant based protein biscuit containing 12% of total energy as protein
Receives: Dietary Supplement: Biscuit acceptance
Plant 20%ExperimentalPlant based protein biscuit containing 20% of total energy as protein
Receives: Dietary Supplement: Biscuit acceptance
Wheat biscuitPlacebo comparatorNot described
Receives: Dietary Supplement: Biscuit acceptance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Taste as assessed by consumer taste panel

    Acceptance of taste

    Measured: Baseline

  2. Mouth feel as assessed by consumer taste panel

    Acceptance of mouth feel

    Measured: Baseline

  3. Appearance as assessed by consumer taste panel

    Acceptance of mouth feel

    Measured: Baseline

  4. 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.

  1. First posted30 Jul 2018
  2. Study start30 Jul 2018 (estimated)
  3. Primary completion1 Dec 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

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)
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

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.

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