NCT03605446

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

June 26, 2018

Last Update Submit

July 20, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Taste as assessed by consumer taste panel

    Acceptance of taste

    Baseline

  • Mouth feel as assessed by consumer taste panel

    Acceptance of mouth feel

    Baseline

  • Appearance as assessed by consumer taste panel

    Acceptance of mouth feel

    Baseline

  • Expected satiety as assessed by consumer taste panel

    Expected satiety from consuming test biscuits

    Baseline

Study Arms (5)

Animal 12%

EXPERIMENTAL

Animal based protein biscuit containing 12% of total energy as protein

Dietary Supplement: Biscuit acceptance

Animal 20%

EXPERIMENTAL

Animal based protein biscuit containing 20% of total energy as protein

Dietary Supplement: Biscuit acceptance

Plant 12%

EXPERIMENTAL

Plant based protein biscuit containing 12% of total energy as protein

Dietary Supplement: Biscuit acceptance

Plant 20%

EXPERIMENTAL

Plant based protein biscuit containing 20% of total energy as protein

Dietary Supplement: Biscuit acceptance

Wheat biscuit

PLACEBO COMPARATOR
Dietary Supplement: Biscuit acceptance

Interventions

Biscuit acceptanceDIETARY_SUPPLEMENT

Acceptance of high protein biscuits

Animal 12%Animal 20%Plant 12%Plant 20%Wheat biscuit

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
No allergies to any food Aged over 40

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

The Rowett Institute

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Bristol University

Bristol, BS8 1TU, United Kingdom

Location

Department of Oncology & Metabolism, University of Sheffield

Sheffield, S10 2RX, United Kingdom

Location

Central Study Contacts

Anthony Watson, PhD

CONTACT

Emma Stevenson, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind white label
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 30, 2018

Study Start

July 30, 2018

Primary Completion

December 1, 2018

Study Completion

December 31, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations