GeneticsNCT04038281
Genetics of Bitter and Fat Taste
An observational study of Genetics and Taste, Altered, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
Obesity is an increasing problem for adults in the UK. Diets high in fat and sugar are the major contributors to weight gain. Individual differences in taste perception are a crucial factor in determining the investigator's choice of foods and an individual's sensitivity to the either bitter or fat taste compounds has… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetics, Taste, Altered, Diet Habit
- What is being tested?
- Sensory tests
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2019to 1 Nov 2019
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Caucasian males and females aged 18-65 years
Who may be able to join
- healthy adults aged 18-65 years
Who cannot join
- pregnancy
- breastfeeding
- smoking
- reported any past or present food allergy or lactose intolerance
- under any medication that might affect taste perception
- known illnesses such as cold, ear infection, sinus infection, or flu
Show all 9Show fewer
- any reported chronic diseases such as (diabetes, CVD, stroke, epilepsy, asthma, cancer)
- any thyroid problems
- individuals that are currently following a diet or weight loss programme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Genetic Variation in the Bitter and Fat Taste Receptor Genes on Taste Perception, Dietary Behaviour and Obesity Status
Obesity is an increasing problem for adults in the UK. Diets high in fat and sugar are the major contributors to weight gain. Individual differences in taste perception are a crucial factor in determining the investigator's choice of foods and an individual's sensitivity to the either bitter or fat taste compounds has been linked to a preference for different foods including sweet and high fat foods. Previous research has not comprehensively explored the effect of both fat and bitter taste sensitivity on dietary intake and obesity status. Therefore, the aim of this study is to explore the associations between genetics, fat and bitter taste sensitivity, food preference, dietary intake and obesity measures in the adult UK population.
Read the detailed description
Demographic data Participants will complete a questionnaire asking about their demographics provided in Appendix. The answers to these questions will be used to control for potential confounding effects in statistical analysis.
Genetic Analysis Saliva samples (2 ml) will be collected for DNA analyses (Genefix, Isohelix, Kent, UK) and stored in the fridge at 4 °C in M201 lab at St Mary's University. DNA extraction will be carried out through use of a PSP® SalivaGene 17 DNA Kit 1011 following the standard manufacturer protocol. DNA quantification and quality control will be assessed with spectroscopy. Following this, genotyping will be carried out using prepared TaqMan® SNP genotyping assays for genes coding for bitter and fat taste receptors and a StepOnePlus thermocycler. All samples will be analysed in duplicate in accordance with the manufacturer's protocol. All genetic analyses will be carried out at St Mary's University, Twickenham.
Anthropometrics Height (m), weight (kg) and waist circumference (cm) will be recorded by the researcher team. BMI will be calculated using the equation: weight (kg)/ height (m2) ± standard deviation and waist circumference and distribution will be compared to the UK standards.
Fat and bitter taste sensitivity The Oral Fatty Acid Threshold Assessment and Ascending Forced Choice Triangle Procedure will be used to determine each participant's oleic acid (C18:1) detection threshold (fat taste sensitivity). Briefly, each participant will be presented with three cups containing 30 ml vehicles in a random arrangement, two controls and the third containing oleic acid (0.02, 0.06, 1, 1.4, 2, 2.8, 3.8, 5, 6.4, 8, 9.8, 12, 20 mM). Participants will have to identify the oleic acid solution by tasting but not ingesting the solutions. A participant will be required to choose the oleic acid solution correctly three times at the same concentration to define their threshold. If participant is incorrect at any point, further three cups will be presented, one containing the higher concentration. There will be thirteen concentrations in total. The bitter taste compound used to classify participants into bitter taste hypo-, normal- and hypertasters will be PTC. Participants will place a strip on the tongue and use the general Labeled Magnitude Scale (gLMS) to report the intensity of the taste compound.
Food preference Food preference will be measured by asking participants to taste food usually perceived as bitter (dark chocolate and broccoli) as well as food that are defined as sweet (milk chocolate and carrots).To minimise variability, the vegetables will be presented raw. Overall preference will be tested using a nine-point Likert scale. Each participants will rinse their mouth with water between each food and a minimum of one minute will be left between each test. Eating behaviour will be determined by use of the validated Adult Eating Behaviour Questionnaire. Fat preference will be determined by a UK adaption of the validated Fat Preference Questionnaire.
Dietary Intake The validated EPIC Norfolk Food Frequency Questionnaire (FFQ) will be used to measure dietary intake over the previous year.
- Conditions
- Genetics, Taste, Altered, Diet Habit, Obesity
- Being tested
- Sensory tests
- Medical subject headings
- Dysgeusia, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory testsOther
Fat, bitter taste sensitivity and food preference measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
BMI
Measured: 1 day observation
Secondary outcomes (3)
Energy intake
Energy intake in kcal obtained with FFQ
Measured: 1 year dietary intake
Fat intake
Fat intake in grams obtained with FFQ
Measured: 1 year dietary intake
Sugar intake
Sugar intake in grams obtained with FFQ
Measured: 1 year dietary intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start15 Aug 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Principal investigator, Kim Wright, St Mary's University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038281
- Sponsor's protocol ID
- SMEC_2018-19_048
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- 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 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Genetic Variation in the Bitter and Fat Taste Receptor Genes on Taste Perception, Dietary Behaviour and Obesity Status
- ClinicalTrials.gov ID
- NCT04038281
- Acronym / sponsor ID
- SMEC_2018-19_048
- Conditions
- Genetics, Taste, Altered, Diet Habit, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 30 Jul 2019 (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.
Obesity is an increasing problem for adults in the UK. Diets high in fat and sugar are the major contributors to weight gain. Individual differences in taste perception are a crucial factor in determining the investigator's choice of foods and an individual's sensitivity to the either bitter or fat taste compounds has been linked to a preference for different foods including sweet and high fat foods. Previous research has not comprehensively explored the effect of both fat and bitter taste sensitivity on dietary intake and obesity status. Therefore, the aim of this study is to explore the associations between genetics, fat and bitter taste sensitivity, food preference, dietary intake and obesity measures in the adult UK population.
Detailed description
Demographic data Participants will complete a questionnaire asking about their demographics provided in Appendix. The answers to these questions will be used to control for potential confounding effects in statistical analysis.
Genetic Analysis Saliva samples (2 ml) will be collected for DNA analyses (Genefix, Isohelix, Kent, UK) and stored in the fridge at 4 °C in M201 lab at St Mary's University. DNA extraction will be carried out through use of a PSP® SalivaGene 17 DNA Kit 1011 following the standard manufacturer protocol. DNA quantification and quality control will be assessed with spectroscopy. Following this, genotyping will be carried out using prepared TaqMan® SNP genotyping assays for genes coding for bitter and fat taste receptors and a StepOnePlus thermocycler. All samples will be analysed in duplicate in accordance with the manufacturer's protocol. All genetic analyses will be carried out at St Mary's University, Twickenham.
Anthropometrics Height (m), weight (kg) and waist circumference (cm) will be recorded by the researcher team. BMI will be calculated using the equation: weight (kg)/ height (m2) ± standard deviation and waist circumference and distribution will be compared to the UK standards.
Fat and bitter taste sensitivity The Oral Fatty Acid Threshold Assessment and Ascending Forced Choice Triangle Procedure will be used to determine each participant's oleic acid (C18:1) detection threshold (fat taste sensitivity). Briefly, each participant will be presented with three cups containing 30 ml vehicles in a random arrangement, two controls and the third containing oleic acid (0.02, 0.06, 1, 1.4, 2, 2.8, 3.8, 5, 6.4, 8, 9.8, 12, 20 mM). Participants will have to identify the oleic acid solution by tasting but not ingesting the solutions. A participant will be required to choose the oleic acid solution correctly three times at the same concentration to define their threshold. If participant is incorrect at any point, further three cups will be presented, one containing the higher concentration. There will be thirteen concentrations in total. The bitter taste compound used to classify participants into bitter taste hypo-, normal- and hypertasters will be PTC. Participants will place a strip on the tongue and use the general Labeled Magnitude Scale (gLMS) to report the intensity of the taste compound.
Food preference Food preference will be measured by asking participants to taste food usually perceived as bitter (dark chocolate and broccoli) as well as food that are defined as sweet (milk chocolate and carrots).To minimise variability, the vegetables will be presented raw. Overall preference will be tested using a nine-point Likert scale. Each participants will rinse their mouth with water between each food and a minimum of one minute will be left between each test. Eating behaviour will be determined by use of the validated Adult Eating Behaviour Questionnaire. Fat preference will be determined by a UK adaption of the validated Fat Preference Questionnaire.
Dietary Intake The validated EPIC Norfolk Food Frequency Questionnaire (FFQ) will be used to measure dietary intake over the previous year.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Caucasian males and females aged 18-65 years
Key inclusion criteria (1 listed)
- healthy adults aged 18-65 years
Key exclusion criteria (9 listed)
- pregnancy
- breastfeeding
- smoking
- reported any past or present food allergy or lactose intolerance
- under any medication that might affect taste perception
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 |
|---|---|---|
| Sensory testsFat, bitter taste sensitivity and food preference measurement | Other | – |
Primary outcome
Obesity
Time frame: 1 day observation
BMI
3 secondary outcomes
Energy intake
Time frame: 1 year dietary intake
Fat intake
Time frame: 1 year dietary intake
Sugar intake
Time frame: 1 year dietary intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetics and Taste, Altered, run by St Mary's University College at 1 site in United Kingdom.
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 1 inclusion and 9 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity (time frame: 1 day observation). 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 30 Jul 2019.