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.
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.
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).
- 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 group | Role | What they receive |
|---|---|---|
| FAAA-enriched | Experimental | food products enriched with FAAA-conjugates Receives: Other: adding taste enhancer |
| Plain | Placebo comparator | Food 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.
discrimination test
percentage correctly identified FAAA-enriched samples
Measured: 90 minutes
descriptive tests
ratings sensory attributes on VAS-scales
Measured: 45 minutes
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.
- First posted26 Dec 2018
- Study start9 Jan 2019 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerry Jager, PhD, Principal investigator, Wageningen University, Division of Human Nutrition
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory and Hedonic Effects of FAAA-conjugates Added to Food Products
- ClinicalTrials.gov ID
- NCT03787394
- Acronym / sponsor ID
- NL67908.081.18
- Conditions
- Sensory Testing
- Keywords
- taste enhancers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 9 Jan 2019 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A two-step, randomised controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| FAAA-enriched | Experimental | Other: adding taste enhancerfood products enriched with FAAA-conjugates |
| Plain | Placebo comparator | Other: adding taste enhancerFood products without FAAA-conjugates |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adding taste enhancerComparing sensory profiles of food products either enriched with FAAA-conjugates or plain | Other | FAAA-enriched, Plain |
Primary outcome
discrimination test
Time frame: 90 minutes
percentage correctly identified FAAA-enriched samples
descriptive tests
Time frame: 45 minutes
ratings sensory attributes on VAS-scales
hedonic test
Time frame: 45 minutes
ratings product liking on VAS-scales
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerry Jager, PhD principal investigator
Wageningen University, Division of Human Nutrition
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.