Protein for Life: Towards a Focused Dietary Framework for Healthy Ageing. Consumer Assessment of High Protein Biscuits (Protein4Life)

July 20, 2018 updated by: Anthony Watson, Newcastle University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS8 1TU
        • Bristol University
      • Sheffield, United Kingdom, S10 2RX
        • Department of Oncology & Metabolism, University of Sheffield
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
        • The Rowett Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

No allergies to any food Aged over 40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Animal 12%
Animal based protein biscuit containing 12% of total energy as protein
Dietary supplement: Biscuit acceptance
Acceptance of high protein biscuits
Experimental: Animal 20%
Animal based protein biscuit containing 20% of total energy as protein
Dietary supplement: Biscuit acceptance
Acceptance of high protein biscuits
Experimental: Plant 12%
Plant based protein biscuit containing 12% of total energy as protein
Dietary supplement: Biscuit acceptance
Acceptance of high protein biscuits
Experimental: Plant 20%
Plant based protein biscuit containing 20% of total energy as protein
Dietary supplement: Biscuit acceptance
Acceptance of high protein biscuits
Placebo Comparator: Wheat biscuit
Dietary supplement: Biscuit acceptance
Acceptance of high protein biscuits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Taste as assessed by consumer taste panel
Time Frame: Baseline
Acceptance of taste
Baseline
Mouth feel as assessed by consumer taste panel
Time Frame: Baseline
Acceptance of mouth feel
Baseline
Appearance as assessed by consumer taste panel
Time Frame: Baseline
Acceptance of mouth feel
Baseline
Expected satiety as assessed by consumer taste panel
Time Frame: Baseline
Expected satiety from consuming test biscuits
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newcastle University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bristol
University of Liverpool
University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 809

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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