NCT03363581

Brief Summary

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 9, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 8, 2023

Completed
Last Updated

August 8, 2023

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

August 9, 2017

Results QC Date

November 12, 2021

Last Update Submit

October 3, 2022

Conditions

Obesity

Keywords

Food preferencesFatWeight loss

Outcome Measures

Primary Outcomes (5)

  • Total Food Intake (Lunch Buffet) at 24 Months

    Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

    24 months

  • Change in Absolute Intake of Fat

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet

    24 months

  • Change in Absolute Intake of Carbohydrates

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet

    24 months

  • Change in Absolute Intake of Sugar

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet

    24 months

  • Change in Absolute Intake of Protein

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet

    24 months

Study Arms (2)

Gastric bypass

Obese patients due to undergo gastric bypass surgery

Behavioral: Food Preference

Control

Healthy free-living individuals

Behavioral: Food Preference

Interventions

Food PreferenceBEHAVIORAL

Buffet meal to assess food preference

ControlGastric bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with obesity attending a specialist obesity clinic and free living individuals.

You may qualify if:

  • Surgical and non-surgical groups:
  • A) Bariatric surgery B) Controls with no history of bariatric surgery
  • Independently mobile
  • Capacity to consent to participate
  • \>18 years of age

You may not qualify if:

  • Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
  • Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
  • Systemic or gastrointestinal condition which may affect food intake or preference, including:
  • i) pregnancy or ii) breast feeding.
  • Active and significant psychiatric illness including substance misuse
  • Significant cognitive or communication issues
  • Medications with documented effect on food intake or food preference
  • History of significant food allergy and certain dietary restrictions
  • History of liver disease or pancreatitis
  • History of bradyarrythmia or congestive cardiac failure group)
  • Use of medications with potential serious interactions with Octreotide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Biospecimen

Retention: NONE RETAINED

Blood- Plasma and Serum

MeSH Terms

Conditions

ObesityFood PreferencesPlatelet Glycoprotein IV DeficiencyWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehaviorBody Weight Changes

Results Point of Contact

Title
Prof Carel le Roux
Organization
Imperial College London
carel.leroux@nhs.net
07970719453

Study Officials

  • Carel le Roux, MBChB, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Investigative Science

Study Record Dates

First Submitted

August 9, 2017

First Posted

December 6, 2017

Study Start

December 15, 2017

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

August 8, 2023

Results First Posted

August 8, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)