- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540693
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
Recruiting
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- Recruiting
- University of Illinois at Urbana Champaign
-
Contact:
- Belen R Acevedo, PhD
- Phone Number: 217-300-4709
- Email: mba17@illinois.edu
-
-
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
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 |
Intervention / Treatment |
---|---|
RYGB-longitudinal
Longitudinal group of subjects studied before and after Roux-n-Y gastric bypass surgery
|
RYGB-weight loss surgery
|
SG_longitudinal
Longitudinal group of subjects studied before and after sleeve gastrectomy surgery
|
SG- weight loss surgery
|
LAGB_longitudinal
Longitudinal group of subjects studied before and after laparoscopic gastric banding surgery
|
LAGB- weight loss surgery
|
Weight-loss success
Subjects who lost ≥40% body weight by 2-5 years post-surgery
|
RYGB-weight loss surgery
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
|
RYGB-weight loss surgery
SG- weight loss surgery
|
What is the study measuring?
Primary Outcome Measures
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.
Collaborators
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)
April 6, 2018
Primary Completion (Anticipated)
April 6, 2023
Study Completion (Anticipated)
July 6, 2023
Study Registration Dates
First Submitted
May 4, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID 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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