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Sensory TestingNCT03787394

Sensory and Hedonic Effects of FAAA-conjugates Added to Food Products

A study testing adding taste enhancer in people with Sensory Testing, run by Wageningen University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Sensory Testing
What is being tested?
adding taste enhancer
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
9 Jan 2019to 30 Apr 2019
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Failure to meet any of the inclusion criteria
  • 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

Trial locations and contacts

No sites are listed yet.

Gerry Jager, PhD contact

+31317485850

gerry.jager@wur.nl

About this study

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.

Read more

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.

Read the detailed description

FAAA conjugates are compounds containing different long-chain fatty acids and simple amino acids. They are involved in multiple signalling pathways playing a role in the regulation of homeostatic and non-homeostatic eating behaviour (Jager \& Witkamp, 2014). FAAA-conjugates are naturally occurring in various animal and plant food sources, yet their dietary relevance and exact mechanism of action remains unclear. Notwithstanding, they have been related to improved food sensations and hedonic effects (Jager \& Witkamp, 2014; Witkamp, 2018; Yoshida et al., 2013). FAAA compounds have been declared GRAS by FEMA, which guarantees their safe use in commercially available food products (Flavour Extract Manufacturers Association, 2018).

According to preliminary observations provided by the research and development department (R\&D) of Givaudan, the addition of specific FAAA-conjugates to a range of food products resulted in an enhancement of several sensory- and hedonic effects in product evaluation. Panellists reported accentuated palatability; aftertaste masking; enhanced fat, sweet, salt and umami perception; and mouthfeel improvement. However, the reproducibility of these results is questionable, as substantial variation in the effects arose both within and between a small sample of volunteers. It is unclear whether these effects are specific for and dependent on integration of these conjugates in a certain food matrix, or if they have a more general boosting effect, relevant for taste or flavour. Perhaps the boosting effect also affects other sensory domains (e.g. vision).

The aforementioned reported sensory/hedonic effects could be attributed to what has been described in literature as the kokumi sensation, which is related to activation of calcium-sensing receptors on the human tongue, albeit the exact mechanism remains to be elucidated (Feng, Zhang, Zhuang, Zhou, \& Xu, 2016; Kuroda \& Miyamura, 2015; Ohsu et al., 2010). Although Kokumi is associated with taste perception, it is most likely not a primary taste, since its effects exist in the context of other taste compounds. On their own, kokumi compounds elicit only very slight or no taste sensations but incorporated in a food matrix they can enhance other taste sensations. The threshold concentration of kokumi compounds in a plain water solution to induce a taste sensation is usually very high, while the threshold concentration in food to enhance other taste sensations can be very low. (Dunkel, Koster, \& Hofmann, 2007; Feng et al., 2016; Kuroda \& Miyamura, 2015).

On the basis of preliminary testing done by R\&D Givaudan, the study described in the current protocol aims to systematically investigate the sensory and hedonic effects of FAAA-conjugates. To do so, specific FAAA-conjugates will be integrated into two food products (one sweet (chocolate milk) and one savoury (salad dressing), which will be sensorially and hedonically evaluated. Furthermore, the dependency of FAAA-conjugates on the food matrix will be studied by administering them separately from food products. An untrained panel will be used, since consumers are not only capable of providing accurate and reliable information about product sensory characteristics, but can also serve as a measure of potential performance of the product in the marketplace (Ares \& Varela, 2017; Lawless \& Heymann, 2010).

If results are in line with the aforementioned preliminary observations, they can add to the body of knowledge and underpin future studies investigating the kokumi sensation and the mechanistic background of FAAA-conjugate effects. Moreover, food product reformulation with the use of FAAA-conjugates could positively impact a wide range of consumers. Due to their boosting sensory/hedonic effects, enriching foods with FAAA-conjugates has the potential to reduce sugar, fat and salt content in a wide range of food products without compromising on experienced flavour, thereby reducing sugar, fat and salt intake and their harmful effects. More importantly, the elderly and seriously ill patients could benefit from the palatability-enhancing effects ascribed to kokumi molecules, which could stimulate appetite and help reverse weight loss (Witkamp, 2018).

  1. OBJECTIVES

Primary Objective(s):

The primary objective of the current study is to determine if there is an objective perceivable difference between plain and FAAA-enriched versions of selected food products and describe sensory and/or hedonic differences between them, using a combination of discrimination testing, descriptive analyses and hedonic tests.

Secondary Objective(s):

The secondary objective is to assess the dependency of FAAA-conjugates on the food matrix, by separating administration of compound and product and assessing how separation affects sensory and hedonic evaluation.

Conditions
Sensory Testing
Being tested
adding taste enhancer
Keywords
taste enhancers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adding taste enhancerOther

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

Study groups in NCT03787394
Study groupRoleWhat they receive
FAAA-enrichedExperimentalfood products enriched with FAAA-conjugates
Receives: Other: adding taste enhancer
PlainPlacebo comparatorFood products without FAAA-conjugates
Receives: Other: adding taste enhancer

What is being measured

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

  1. discrimination test

    percentage correctly identified FAAA-enriched samples

    Measured: 90 minutes

  2. descriptive tests

    ratings sensory attributes on VAS-scales

    Measured: 45 minutes

  3. hedonic test

    ratings product liking on VAS-scales

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start9 Jan 2019 (estimated)
  3. Primary completion30 Apr 2019 (estimated)
  4. Study completion30 Apr 2019 (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
Crossover
Model description
A two-step, randomised controlled intervention study
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787394
Sponsor's protocol ID
NL67908.081.18
Status last verified
Dec 2018
First submitted
24 Dec 2018
Last updated
26 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing adding taste enhancer in people with Sensory Testing, run by Wageningen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Gerry Jager, PhD (+31317485850, gerry.jager@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

discrimination test (time frame: 90 minutes). The study lists 3 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 26 Dec 2018.

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