Bariatric Surgery CandidateFaTSSNCT03540693
Fat Taste Sensory Study
An observational study of Bariatric Surgery Candidate and Bariatric Surgical Procedure, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Bariatric Surgical Procedure
- What is being tested?
- RYGB, SG and LAGB
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 6 Jul 2023
- How long will I take part?
- 1 Year
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
Belen R Acevedo, PhD, 217-300-4709, mba17@illinois.edu
Marta Y Pepino, PhD
About this study
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.
Read the 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.
- Being tested
- RYGB, SG, LAGB
- Keywords
- Bariatric surgery, gastric bypass surgery, sleeve gastrectomy, laparoscopic gastric banding, food preferences, flavor perception
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RYGBProcedure or surgery
RYGB-weight loss surgery
SGProcedure or surgery
SG- weight loss surgery
LAGBProcedure or surgery
LAGB- weight loss surgery
| Study group | Role | What they receive |
|---|---|---|
| RYGB-longitudinal | Longitudinal group of subjects studied before and after Roux-n-Y gastric bypass surgery Receives: Procedure: RYGB | |
| SG_longitudinal | Longitudinal group of subjects studied before and after sleeve gastrectomy surgery Receives: Procedure: SG | |
| LAGB_longitudinal | Longitudinal group of subjects studied before and after laparoscopic gastric banding surgery Receives: Procedure: LAGB | |
| Weight-loss success | Subjects who lost ≥40% body weight by 2-5 years post-surgery Receives: Procedure: RYGB; Procedure: SG | |
| 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 Receives: Procedure: RYGB; Procedure: SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavor perception
Changes in perception of flavor intensity in the general label magnitude scale (in mm)
Measured: 3-6 months
Flavor preference
Changes in perception of hedonic value in the hedonic version of the general label magnitude scale (in mm)
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start6 Apr 2018
- Primary completion6 Apr 2023 (estimated)
- Study completion6 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 105 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Carle Foundation Hospital
- Responsible party
- Principal investigator, Marta Yanina Pepino de Gruev, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540693
- Sponsor's protocol ID
- 18439
- Acronym
- FaTSS
- Status last verified
- Apr 2021
- First submitted
- 4 May 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Taste Sensory Study
- ClinicalTrials.gov ID
- NCT03540693
- Acronym / sponsor ID
- FaTSS / 18439
- Keywords
- Bariatric surgery, gastric bypass surgery, sleeve gastrectomy, laparoscopic gastric banding, food preferences, flavor perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Carle Foundation Hospital
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 6 Apr 2023 (estimated)
- Study completion
- 6 Jul 2023 (estimated)
- First posted
- 30 May 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RYGB-longitudinal | – | Procedure: RYGBLongitudinal group of subjects studied before and after Roux-n-Y gastric bypass surgery |
| SG_longitudinal | – | Procedure: SGLongitudinal group of subjects studied before and after sleeve gastrectomy surgery |
| LAGB_longitudinal | – | Procedure: LAGBLongitudinal group of subjects studied before and after laparoscopic gastric banding surgery |
| Weight-loss success | – | Procedure: RYGB, Procedure: SGSubjects who lost ≥40% body weight by 2-5 years post-surgery |
| Weight-loss failure | – | Procedure: RYGB, Procedure: SGSubjects who lost <25% body weight (or lost more but then regain weight so that now are at <25%) by 2-5 years post-surgery |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| RYGBRYGB-weight loss surgery | Procedure or surgery | RYGB-longitudinal, Weight-loss failure, Weight-loss success |
| SGSG- weight loss surgery | Procedure or surgery | SG_longitudinal, Weight-loss failure, Weight-loss success |
| LAGBLAGB- weight loss surgery | Procedure or surgery | LAGB_longitudinal |
Primary outcome
Flavor perception
Time frame: 3-6 months
Changes in perception of flavor intensity in the general label magnitude scale (in mm)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Bariatric Surgical Procedure, run by University of Illinois at Urbana-Champaign at 1 site 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavor perception (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.