Fat Taste Sensory Study (FaTSS)

April 26, 2021 updated by: Marta Yanina Pepino de Gruev, University of Illinois at Urbana-Champaign
Fat is the most energy dense macronutrient and consuming fat has been positively correlated to obesity. Individuals afflicted with obesity crave fat more frequently, have a higher preference for fatty taste, and consume a higher quantity of fatty foods. People who have undergone Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) weight-loss surgeries dramatically decrease their fat preferences and consumption of fat, at least within the first year after surgery. These surgeries are very effective in helping people lose weight over the first couple of years; however, approximately 30% of those who undergo these surgeries start regaining weight after the second year mark. Why some people are able to keep the weight off long-term but others are unable to is unclear. In addition, it is well-known that fat can modify the flavor of foods and flavor plays a critical role in consumption, as well as in responses that gear up the body to consume the food. These are known as cephalic phase responses and include neural, physiological, and hormonal aspects. The main goals of the study are twofold: 1) To test the immediate effects of RYGB surgery, SG surgery, and laparoscopic gastric banding (LAGB) surgery (a weight loss control group) on fat preferences and sensory perception, and 2) to compare fat preferences and sensory perception between those who are able to achieve sustained weight loss 2-5 years after RYGB or SG surgery and those who either regained weight or did not lose the desired amount.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For the first goal, the investigators will assess a longitudinal group of subjects both before RYGB surgery (n=15) SG surgery (n=15), and LAGB surgery (n=15), and then again after they lose ~16% of their body weight post-surgery in the fed and the fasted state. the investigators will also study the same variables in a cross-sectional design consisting of two groups: a weight success group (n=30) and a weight failure group (n=30) 2-5 years post RYGB or SG surgery. The weight success group will include subjects who lost ≥40% body weight by 2-5 years post-surgery and the weight failure group will include subjects who lost <25% body weight by 2-5 years post-surgery. In addition, the investigators will also explore the extent to which fat preferences and sensory perception in these subjects are affected by flavor related genes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

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

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana Champaign
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1) Participants scheduled to undergo Roux-en- Y Gastric Bypass (RYGB) surgery, Sleeve Gastrectomy (SG) surgery, or Laparoscopic Gastric Banding (LAGB) surgery or 2) have had RYGB or SG surgery 2-5 years ago and fall into one of two groups: Group 2a) as a result of the surgery she/he lost ≥40% of pre-surgery body weight and was able to keep it off until now or Group 2b) lost <25% of pre-surgery body weight or lost more but regained the weight.

Description

Inclusion Criteria:

  • Women and men, 18-64 years of age, all races
  • Subjects must be scheduled to undergo Roux-en-Y Gastric Bypass surgery (RYGB), Sleeve Gastrectomy surgery (SG), or laparoscopic gastric banding surgery (LAGB) and be available to be tested both pre- and post-surgery or must have undergone RYGB or SG surgery between 2-5 (i.e. at least two years ago and not more than 5) years ago and have a current weight loss that is ≥40% of body weight pre-surgery or <25% of body weight pre-surgery.

Exclusion Criteria:

  • Smoking tobacco related cigarettes or having quit smoking less than 6 months ago
  • Pregnant or breastfeeding
  • Are experiencing significant organ dysfunction
  • Take medications that could influence research results
  • Have any psychiatric illness or disorder that could influence compliance or completion of the study
  • History of chronic rhinitis
  • Had a diagnosis of or are taking medicine to treat diabetes
  • Inflammatory intestinal disease
  • Subjects who underwent RYGB or SG between 2-3 years ago and have a current weight loss that is <40% and ≥25% of their body weight pre-surgery.
  • Subjects must find the taste of the food to be sham-fed acceptable (e.g. cream cheese, etc.).

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

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RYGB-longitudinal
Longitudinal group of subjects studied before and after Roux-n-Y gastric bypass surgery
Procedure: RYGB
RYGB-weight loss surgery
SG_longitudinal
Longitudinal group of subjects studied before and after sleeve gastrectomy surgery
Procedure: SG
SG- weight loss surgery
LAGB_longitudinal
Longitudinal group of subjects studied before and after laparoscopic gastric banding surgery
Procedure: LAGB
LAGB- weight loss surgery
Weight-loss success
Subjects who lost ≥40% body weight by 2-5 years post-surgery
Procedure: RYGB
RYGB-weight loss surgery
Procedure: SG
SG- weight loss surgery
Weight-loss failure
Subjects who lost <25% body weight (or lost more but then regain weight so that now are at <25%) by 2-5 years post-surgery
Procedure: RYGB
RYGB-weight loss surgery
Procedure: SG
SG- weight loss surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flavor perception
Time Frame: 3-6 months
Changes in perception of flavor intensity in the general label magnitude scale (in mm)
3-6 months
Flavor preference
Time Frame: 3-6 months
Changes in perception of hedonic value in the hedonic version of the general label magnitude scale (in mm)
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carle Foundation Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18439

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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