- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548038
Taste Changes With Bariatric Surgery
October 29, 2020 updated by: Elizabeth Parks, University of Missouri-Columbia
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri
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Columbia, Missouri, United States, 65212
- Elizabeth Parks
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery Clinic.
Description
Inclusion Criteria:
- Women who plan to undergo bariatric surgery.
- Age: 21-70y.
- Non-smokers (at least 3 months post smoking cessation).
- Non-diabetic or prediabetic
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bariatric surgery patients
All subjects will be patients scheduled for bariatric surgery.
There is only one arm in this study.
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All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Taste Perception on an Interval Scale
Time Frame: Change from baseline to one month after bariatric surgery
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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.
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Change from baseline to one month after bariatric surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Scruggs 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.
- Pepino 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 24, 2018
Primary Completion (ACTUAL)
December 20, 2019
Study Completion (ACTUAL)
May 4, 2020
Study Registration Dates
First Submitted
May 24, 2018
First Submitted That Met QC Criteria
June 5, 2018
First Posted (ACTUAL)
June 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011543
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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