NCT03540693

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

May 4, 2018

Last Update Submit

April 26, 2021

Conditions

Keywords

Bariatric surgerygastric bypass surgerysleeve gastrectomylaparoscopic gastric bandingfood preferencesflavor perception

Outcome Measures

Primary Outcomes (2)

  • Flavor perception

    Changes in perception of flavor intensity in the general label magnitude scale (in mm)

    3-6 months

  • Flavor preference

    Changes in perception of hedonic value in the hedonic version of the general label magnitude scale (in mm)

    3-6 months

Study Arms (5)

RYGB-longitudinal

Longitudinal group of subjects studied before and after Roux-n-Y gastric bypass surgery

Procedure: RYGB

SG_longitudinal

Longitudinal group of subjects studied before and after sleeve gastrectomy surgery

Procedure: SG

LAGB_longitudinal

Longitudinal group of subjects studied before and after laparoscopic gastric banding surgery

Procedure: LAGB

Weight-loss success

Subjects who lost ≥40% body weight by 2-5 years post-surgery

Procedure: RYGBProcedure: 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

Procedure: RYGBProcedure: SG

Interventions

RYGBPROCEDURE

RYGB-weight loss surgery

RYGB-longitudinalWeight-loss failureWeight-loss success
SGPROCEDURE

SG- weight loss surgery

SG_longitudinalWeight-loss failureWeight-loss success
LAGBPROCEDURE

LAGB- weight loss surgery

LAGB_longitudinal

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from saliva

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Ingestive Behavior

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 30, 2018

Study Start

April 6, 2018

Primary Completion

April 6, 2023

Study Completion

July 6, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations