NCT03787394

Brief Summary

Rationale: According to preliminary observations provided by the research and development department (R\&D) of Givaudan, addition of specific fatty acid-amino acid (FAAA)-conjugates to a wide range of food products resulted in an enhancement of several sensory and hedonic effects. Such effects could be attributed to the so-called kokumi sensation, a taste concept that has been described as a "taste enhancer" that magnifies and lengthens all the other five basic tastes. The exact mechanisms of the kokumi sensation are as of yet unclear. Perception of the kokumi sensation depends on the context of other taste compounds and integration into food matrices. A systematic investigation is necessary to objectively evaluate whether the addition of specific FAAA-conjugates results in the enhancement of sensory and hedonic effects. Furthermore, we want to assess the dependency of these effects on the food matrix. To do so, a combination of discrimination, descriptive and hedonic testing will be carried out. Objectives: The primary objectives are: to determine if there is a perceivable difference between plain and FAAA-enriched versions of selected food products and describe sensory and/or hedonic differences between them; to assess the dependency of FAAA-conjugates on the food matrix. Study design: A two-step, randomised controlled intervention study will be carried out. Study population: 40 healthy, adult (18-55 years) males and females (BMI 18 - 27 kg/m2) from Wageningen and surroundings will be included. Intervention (if applicable): FAAA-conjugates: in step one, FAAA-conjugates will be integrated into food products; in step two, FAAA-conjugates will both be administered separately (using a tasteless mouthwash) and integrated into food products. Main study parameters/endpoints: The primary outcome parameters are: proportion of correct answers (discrimination testing); sensory evaluation score means (descriptive testing); and hedonic evaluation score means (hedonic testing). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The current study is non-therapeutic to subjects. Risks associated with participation are negligible and compared to other studies, the burden can be considered low. The FAAA-conjugates used in the intervention are declared "generally recognised as safe" (GRAS) by the Flavour Extract Manufacturers Association (FEMA) and pose no known adverse health effects.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

January 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

December 24, 2018

Last Update Submit

December 24, 2018

Conditions

Keywords

taste enhancers

Outcome Measures

Primary Outcomes (3)

  • discrimination test

    percentage correctly identified FAAA-enriched samples

    90 minutes

  • descriptive tests

    ratings sensory attributes on VAS-scales

    45 minutes

  • hedonic test

    ratings product liking on VAS-scales

    45 minutes

Study Arms (2)

FAAA-enriched

EXPERIMENTAL

food products enriched with FAAA-conjugates

Other: adding taste enhancer

Plain

PLACEBO COMPARATOR

Food products without FAAA-conjugates

Other: adding taste enhancer

Interventions

Comparing sensory profiles of food products either enriched with FAAA-conjugates or plain

FAAA-enrichedPlain

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-55 years
  • BMI: 18.0 - 27.0 kg/m2
  • Healthy (as judged by subject)
  • Consumer of products used in the study
  • Proficient in spoken and written English.

You may not qualify if:

  • Weight loss or weight gain of 5 kg or more during the last 2 months
  • Regular smoker (\> 1 cigarette per day);
  • Restrained eater, assessed by the DEBQ (score of \>2.37 for men and \>3.24 for women (van Strien, Frijters, Bergers, \& Defares, 1986))
  • Pregnant or lactating woman
  • Anosmia or ageusia (self-reported)
  • Food allergies or intolerances relevant for the food products used in the experiment
  • Student/employee of the WUR Sensory Science and Eating Behaviour department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gerry Jager, PhD

    Wageningen University, Division of Human Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerry Jager, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A two-step, randomised controlled intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 26, 2018

Study Start

January 9, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

December 26, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share