ObesityNCT03149666
Quantitative Evaluation of Bitter Taste in Obesity
An observational study of Obesity, run by University of Sao Paulo.
Trial summary
Although taste influences food choices and favours diseases like obesity, there is no consensus about the existence of correlations between bitterness and anthropometric variables. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 1 Jul 2016
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy people without obesity and people with obesity.
Who may be able to join
- Weight limit of 150 kg and who are able to read the text with the guidelines on how to be punctuated the sensation of bitter in the generalized labeled scale.
Who cannot join
- Being a relative of the first degree of a patient already included in the research, tobacco in the forms of cigarettes, pipes and cigars in the last 30 days, presence of coryza, nasal congestion or frequent sneezing, dental treatment on the same day of the research. Being a dementia sufferer, having an altered, drowsy level of consciousness. Show upper limb tremor visible.
About this study
Official title: Anthropometric Variables and Perception of Bitter Taste in Obese Adults or Not
Although taste influences food choices and favours diseases like obesity, there is no consensus about the existence of correlations between bitterness and anthropometric variables. Also, an electronic-based method for data collection could provide a more appropriate way for the evaluation of taste perception and save time.
The objective is to search for correlations between bitterness and anthropometric variables.
Read the detailed description
A cross-sectional study evaluating correlations between the bitterness rates given on a generalized Labeled Magnitude Scale, anthropometrics and other variables. Bitterness perceptions at the tip of the tongue (TOTp) and at the whole mouth (WMp) were recorded using a locally developed novel cloud-based software (Cloud-gLMS). The ANCOVA test was adjusted using TOTp and WMp as dependent variables and age, height, weight, BMI, gender, waist circumference, alcohol intake, comorbidities, and use of medications as independent variables.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of bitter taste | Participants will be evaluated as to the intensity of bitter taste when performing watery mouthwash with quinine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of bitter taste 1
It will be gently applied at the end of the tongue, by means of a swab soaked in the quinine solution at room temperature, in continuous movements from left to right, and will point a note to the bitter level.
Measured: 1 time
Sensitivity of bitter taste 2
The volunteer will perform a "mouthwash" with the quinine solution, and will point a note to the bitter level.
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Feb 2015
- Primary completion31 Jan 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Sergio Marchini, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149666
- Sponsor's protocol ID
- HCRP 924/2015
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reiter ER, DiNardo LJ, Costanzo RM. Toxic effects on gustatory function. Adv Otorhinolaryngol. 2006;63:265-277. doi: 10.1159/000093765.
PubMed 16733344Sharma K, Kaur GK. PTC bitter taste genetic polymorphism, food choices, physical growth in body height and body fat related traits among adolescent girls from Kangra Valley, Himachal Pradesh (India). Ann Hum Biol. 2014 Jan-Feb;41(1):29-39. doi: 10.3109/03014460.2013.822929. Epub 2013 Aug 12.
PubMed 23937293Keller KL, Adise S. Variation in the Ability to Taste Bitter Thiourea Compounds: Implications for Food Acceptance, Dietary Intake, and Obesity Risk in Children. Annu Rev Nutr. 2016 Jul 17;36:157-82. doi: 10.1146/annurev-nutr-071715-050916. Epub 2016 Apr 6.
PubMed 27070900Bartoshuk LM, Duffy VB, Green BG, Hoffman HJ, Ko CW, Lucchina LA, Marks LE, Snyder DJ, Weiffenbach JM. Valid across-group comparisons with labeled scales: the gLMS versus magnitude matching. Physiol Behav. 2004 Aug;82(1):109-14. doi: 10.1016/j.physbeh.2004.02.033.
PubMed 15234598Segovia C, Hutchinson I, Laing DG, Jinks AL. A quantitative study of fungiform papillae and taste pore density in adults and children. Brain Res Dev Brain Res. 2002 Oct 20;138(2):135-46. doi: 10.1016/s0165-3806(02)00463-7.
PubMed 12354641
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric Variables and Perception of Bitter Taste in Obese Adults or Not
- ClinicalTrials.gov ID
- NCT03149666
- Acronym / sponsor ID
- HCRP 924/2015
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 11 May 2017 (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.
Although taste influences food choices and favours diseases like obesity, there is no consensus about the existence of correlations between bitterness and anthropometric variables. Also, an electronic-based method for data collection could provide a more appropriate way for the evaluation of taste perception and save time.
The objective is to search for correlations between bitterness and anthropometric variables.
Detailed description
A cross-sectional study evaluating correlations between the bitterness rates given on a generalized Labeled Magnitude Scale, anthropometrics and other variables. Bitterness perceptions at the tip of the tongue (TOTp) and at the whole mouth (WMp) were recorded using a locally developed novel cloud-based software (Cloud-gLMS). The ANCOVA test was adjusted using TOTp and WMp as dependent variables and age, height, weight, BMI, gender, waist circumference, alcohol intake, comorbidities, and use of medications as independent variables.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of bitter taste | – | –Participants will be evaluated as to the intensity of bitter taste when performing watery mouthwash with quinine. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy people without obesity and people with obesity.
Key inclusion criteria (1 listed)
- Weight limit of 150 kg and who are able to read the text with the guidelines on how to be punctuated the sensation of bitter in the generalized labeled scale.
Key exclusion criteria (1 listed)
- Being a relative of the first degree of a patient already included in the research, tobacco in the forms of cigarettes, pipes and cigars in the last 30 days, presence of coryza, nasal congestion or frequent sneezing, dental treatment on the same day of the research. Being a dementia sufferer, having an altered, drowsy level of consciousness. Show upper limb tremor visible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of bitter taste 1
Time frame: 1 time
It will be gently applied at the end of the tongue, by means of a swab soaked in the quinine solution at room temperature, in continuous movements from left to right, and will point a note to the bitter level.
Sensitivity of bitter taste 2
Time frame: 1 time
The volunteer will perform a "mouthwash" with the quinine solution, and will point a note to the bitter level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Background: PubMed 16733344Reiter ER, DiNardo LJ, Costanzo RM. Toxic effects on gustatory function. Adv Otorhinolaryngol. 2006;63:265-277. doi: 10.1159/000093765.
- Background: PubMed 23937293Sharma K, Kaur GK. PTC bitter taste genetic polymorphism, food choices, physical growth in body height and body fat related traits among adolescent girls from Kangra Valley, Himachal Pradesh (India). Ann Hum Biol. 2014 Jan-Feb;41(1):29-39. doi: 10.3109/03014460.2013.822929. Epub 2013 Aug 12.
- Background: PubMed 27070900Keller KL, Adise S. Variation in the Ability to Taste Bitter Thiourea Compounds: Implications for Food Acceptance, Dietary Intake, and Obesity Risk in Children. Annu Rev Nutr. 2016 Jul 17;36:157-82. doi: 10.1146/annurev-nutr-071715-050916. Epub 2016 Apr 6.
- Background: PubMed 15234598Bartoshuk LM, Duffy VB, Green BG, Hoffman HJ, Ko CW, Lucchina LA, Marks LE, Snyder DJ, Weiffenbach JM. Valid across-group comparisons with labeled scales: the gLMS versus magnitude matching. Physiol Behav. 2004 Aug;82(1):109-14. doi: 10.1016/j.physbeh.2004.02.033.
- Background: PubMed 12354641Segovia C, Hutchinson I, Laing DG, Jinks AL. A quantitative study of fungiform papillae and taste pore density in adults and children. Brain Res Dev Brain Res. 2002 Oct 20;138(2):135-46. doi: 10.1016/s0165-3806(02)00463-7.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruiting
Puerto Rican Obesity Intervention for Men
Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Sao Paulo.
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 1 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: finished, as of the sponsor's last update on 11 May 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of bitter taste 1 (time frame: 1 time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149666, which also lists 5 linked publications.
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 11 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.