ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 4 for:    Recruiting, Not yet recruiting, Available Studies | "Dysgeusia"

Taste Changes With Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03548038
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Parks, University of Missouri-Columbia

Brief 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. 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.

Condition or disease Intervention/treatment
Taste, Altered Other: taste test

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
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Taste Changes With Bariatric Surgery
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : May 4, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bariatric surgery patients
All subjects will be patients scheduled for bariatric surgery. There is only one arm in this study.
Other: taste test
All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Before bariatric surgery, the subject will lightly scrape the inside of their cheek to harvest cells. These cell will be frozen for future DNA extraction and detection of taste receptor genes, T1R2 and T1R3.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female subjects will be included.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 21-44 will be recruited from the University of Missouri Bariatric Surgery Clinic.
Criteria

Inclusion Criteria:

  • Women who plan to undergo bariatric surgery.
  • Age: 21-44y (premenopausal women only).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548038


Contacts
Contact: Elizabeth J Parks, PhD (573) 882-5864 parksej@missouri.edu

Locations
United States, Missouri
Elizabeth Parks Recruiting
Columbia, Missouri, United States, 65212
Contact: Elizabeth Parks, PhD    573-882-5864    parksej@missouri.edu   
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Elizabeth J Parks, PhD University of Missouri-Columbia

Publications:
Responsible Party: Elizabeth Parks, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03548038     History of Changes
Other Study ID Numbers: 2011543
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Parks, University of Missouri-Columbia:
taste perception
bariatric surgery
taste preference
weight loss surgery

Additional relevant MeSH terms:
Dysgeusia
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms