Taste, AlteredNCT03548038
Taste Changes With Bariatric Surgery
An observational study of Taste, Altered, run by University of Missouri-Columbia at 2 sites in United States.
Trial summary
It is commonly believed that a link exists between BMI and taste perception. One group of researchers observed that women who are obese experience reduced taste sensitivity when compared to normal-weight controls. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Taste, Altered
- What is being tested?
- taste test
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2018to 4 May 2020
- 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery Clinic.
Who may be able to join
- Women who plan to undergo bariatric surgery.
- Age: 21-70y.
- Non-smokers (at least 3 months post smoking cessation).
- Non-diabetic or prediabetic
Who cannot join
- Subject on a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
- Inability to understand the test instructions.
- Subject has already undergone bariatric surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elizabeth Parks
Columbia, Missouri, 65212
University of Missouri
Columbia, Missouri, 65212
About this study
It is commonly believed that a link exists between BMI and taste perception. One group of researchers observed that women who are obese experience reduced taste sensitivity when compared to normal-weight controls. Others have compared taste sensitivity between lean and obese subjects and found no significant differences. The inconsistencies in these studies demonstrate how much variation in taste sensitivity is possible when different factors are applied in research. Throughout several studies, one element remains constant - bariatric surgery causes appetite aversions. These changes in appetite and food preference likely have a large influence on the overall magnitude of post-surgical weight loss. Although many studies have investigated the changes in taste preference after bariatric surgery, few, if any, have focused on changes in sweet taste perception.
Read the detailed description
The overall goal of the present project is to determine how future bariatric surgery will affect the taste for sweet liquids. Taste perception will be assessed before surgery (pre-operative, pre-op) and after bariatric surgery, at approximately 1 month. Taste studies will be conducted with solutions prepared freshly before each test using sucrose dissolved in distilled water. Six concentrations of sucrose (table sugar) will be tasted in random order, with the most concentrated solution being roughly the sweetness of soda. The subject is blinded to the concentrations. It is hypothesized that there will be no significant difference in taste perception when pre-op and post-op values are compared. However, the investigators hypothesize that taste preference will identify solutions with lower concentrations post-op.
- Conditions
- Taste, Altered
- Being tested
- taste test
- Keywords
- taste perception, bariatric surgery, taste preference, weight loss surgery
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taste testOther
All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery patients | All subjects will be patients scheduled for bariatric surgery. There is only one arm in this study. Receives: Other: taste test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste Perception on an Interval Scale
Taste perception will be assessed by the subjects' responses to varying sucrose solutions. The interval scale begins with "barely detectable" at zero and goes up to "strongest imaginable" at 10. Subjects will be asked to draw an "X" at the location on the graph corresponding to their perception.
Measured: Change from baseline to one month after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start24 May 2018
- Primary completion20 Dec 2019
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Taste, AlteredStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Parks, University of Missouri-Columbia
- Investigators
- Elizabeth J Parks, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548038
- Sponsor's protocol ID
- 2011543
- Status last verified
- Mar 2020
- First submitted
- 24 May 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bueter M, Miras AD, Chichger H, Fenske W, Ghatei MA, Bloom SR, Unwin RJ, Lutz TA, Spector AC, le Roux CW. Alterations of sucrose preference after Roux-en-Y gastric bypass. Physiol Behav. 2011 Oct 24;104(5):709-21. doi: 10.1016/j.physbeh.2011.07.025. Epub 2011 Jul 30.
PubMed 21827777Scruggs DM, Buffington C, Cowan GS Jr. Taste Acuity of the Morbidly Obese before and after Gastric Bypass Surgery. Obes Surg. 1994 Feb;4(1):24-28. doi: 10.1381/096089294765558854.
PubMed 10742759Pepino MY, Finkbeiner S, Beauchamp GK, Mennella JA. Obese women have lower monosodium glutamate taste sensitivity and prefer higher concentrations than do normal-weight women. Obesity (Silver Spring). 2010 May;18(5):959-65. doi: 10.1038/oby.2009.493. Epub 2010 Jan 14.
PubMed 20075854
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Changes With Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03548038
- Acronym / sponsor ID
- 2011543
- Conditions
- Taste, Altered
- Keywords
- taste perception, bariatric surgery, taste preference, weight loss surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 6 Jun 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.
It is commonly believed that a link exists between BMI and taste perception. One group of researchers observed that women who are obese experience reduced taste sensitivity when compared to normal-weight controls. Others have compared taste sensitivity between lean and obese subjects and found no significant differences. The inconsistencies in these studies demonstrate how much variation in taste sensitivity is possible when different factors are applied in research. Throughout several studies, one element remains constant - bariatric surgery causes appetite aversions. These changes in appetite and food preference likely have a large influence on the overall magnitude of post-surgical weight loss. Although many studies have investigated the changes in taste preference after bariatric surgery, few, if any, have focused on changes in sweet taste perception.
Detailed description
The overall goal of the present project is to determine how future bariatric surgery will affect the taste for sweet liquids. Taste perception will be assessed before surgery (pre-operative, pre-op) and after bariatric surgery, at approximately 1 month. Taste studies will be conducted with solutions prepared freshly before each test using sucrose dissolved in distilled water. Six concentrations of sucrose (table sugar) will be tasted in random order, with the most concentrated solution being roughly the sweetness of soda. The subject is blinded to the concentrations. It is hypothesized that there will be no significant difference in taste perception when pre-op and post-op values are compared. However, the investigators hypothesize that taste preference will identify solutions with lower concentrations post-op.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery patients | – | Other: taste testAll subjects will be patients scheduled for bariatric surgery. There is only one arm in this study. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery Clinic.
Key inclusion criteria (4 listed)
- Women who plan to undergo bariatric surgery.
- Age: 21-70y.
- Non-smokers (at least 3 months post smoking cessation).
- Non-diabetic or prediabetic
Key exclusion criteria (3 listed)
- Subject on a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
- Inability to understand the test instructions.
- Subject has already undergone bariatric surgery
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 |
|---|---|---|
| taste testAll subjects will complete a procedure to determine their taste sensitivity to sweet tastants. | Other | Bariatric surgery patients |
Primary outcome
Taste Perception on an Interval Scale
Time frame: Change from baseline to one month after bariatric surgery
Taste perception will be assessed by the subjects' responses to varying sucrose solutions. The interval scale begins with "barely detectable" at zero and goes up to "strongest imaginable" at 10. Subjects will be asked to draw an "X" at the location on the graph corresponding to their perception.
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 2 Nov 2020.
- Background: PubMed 21827777Bueter M, Miras AD, Chichger H, Fenske W, Ghatei MA, Bloom SR, Unwin RJ, Lutz TA, Spector AC, le Roux CW. Alterations of sucrose preference after Roux-en-Y gastric bypass. Physiol Behav. 2011 Oct 24;104(5):709-21. doi: 10.1016/j.physbeh.2011.07.025. Epub 2011 Jul 30.
- Background: PubMed 10742759Scruggs DM, Buffington C, Cowan GS Jr. Taste Acuity of the Morbidly Obese before and after Gastric Bypass Surgery. Obes Surg. 1994 Feb;4(1):24-28. doi: 10.1381/096089294765558854.
- Background: PubMed 20075854Pepino MY, Finkbeiner S, Beauchamp GK, Mennella JA. Obese women have lower monosodium glutamate taste sensitivity and prefer higher concentrations than do normal-weight women. Obesity (Silver Spring). 2010 May;18(5):959-65. doi: 10.1038/oby.2009.493. Epub 2010 Jan 14.
- 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.
Elizabeth J Parks, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Taste, Altered, run by University of Missouri-Columbia at 2 sites in United States.
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 4 inclusion and 3 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Taste Perception on an Interval Scale (time frame: Change from baseline to one month after bariatric surgery). 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 NCT03548038, which also lists 3 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 2 Nov 2020.