Taste Changes With Bariatric Surgery | NCT03548038

Studies
Taste Changes With Bariatric Surgery

NCT03548038

Sponsor

University of Missouri-Columbia

Status

Completed

Last Update Posted

Nov 2, 2020Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Taste, Altered

Interventions

taste test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2018Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

May 4, 2020Actual

First Submitted Date

May 24, 2018

First Submission Date that Met QC Criteria

Jun 5, 2018

First Posted Date

Jun 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2020

Last Update Posted Date

Nov 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Parks, Professor, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric surgery patients		All subjects will be patients scheduled for bariatric surgery. There is only one arm in this study.	Other: taste test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
taste test	Other	All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.	Bariatric surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Change from baseline to one month after bariatric surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female subjects will be included.

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery Clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth J Parks, PhD	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elizabeth Parks		Columbia	Missouri	65212	United States
University of Missouri

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21827777	Background	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.
10742759	Background	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.

ID	Term
D013651	Taste Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases