NCT04600596

Brief Summary

Direct measurements of changes in food selection in humans after RYGB have been limited by the unreliability of patients, which poses significant methodological and conceptual challenges to researchers and study design. Self-monitoring requires time and effort, and many find tracking of dietary intake tedious, which contributes to attrition. Direct measurements, however, represent an essential component in the attempt to understand how RYGB alters eating and food preferences, but laboratory settings preclude a real-life environment. The aim of this study is to investigate changes in food preferences, total energy intake of the three primary macronutrients and meal patterns between obese women (BMI ≥ 35) before and after Roux-en-Y gastric bypass and lean (BMI ≤ 25) and obese (BMI ≥ 35) controls by means of photographic food recognition with a mobile application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

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

Study Start

First participant enrolled

June 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

October 7, 2020

Last Update Submit

August 14, 2023

Conditions

Keywords

Photographic Food RecognitionMorbid ObesityBariatric SurgeryRYGBFood Preferences

Outcome Measures

Primary Outcomes (1)

  • Changes in total energy intake of the three primary macronutrients before and after RYGB.

    Difference in changes of total energy intake of the three primary macronutrients within RYGB patients and between patients and controls.

    Baseline, 3, 6, and 12 month post surgery.

Secondary Outcomes (6)

  • Changes in food groups preferences before and after RYGB.

    Baseline, 3, 6, and 12 month post surgery.

  • Changes in meal speed before and after RYGB.

    Baseline, 3, 6, and 12 month post surgery.

  • Changes in number of meals per day before and after RYGB.

    Baseline, 3, 6, and 12 month post surgery.

  • Changes in meal size before and after RYGB.

    Baseline, 3, 6, and 12 month post surgery.

  • Correlation of energy (kcal) and type of macronutrients consumed (kcal/24h) with % weight loss before and after RYGB.

    Baseline, 3, 6, and 12 month post surgery.

  • +1 more secondary outcomes

Study Arms (3)

Roux-en-Y gastric bypass patients

Severely obese non-diabetic adult female patients scheduled for RYGB.

Behavioral: Recording of food intake.

Obese (BMI ≥ 35) controls

Severely obese non-diabetic adult female patients not undergoing surgery.

Behavioral: Recording of food intake.

Lean (BMI ≤ 25) controls

Lean healthy non-diabetic adult females.

Behavioral: Recording of food intake.

Interventions

The food intake is recorded with a photographic food recognition mobile application. The total energy expenditure is recorded with the DLW method.

Also known as: Double labeled water (DLW) method.
Lean (BMI ≤ 25) controlsObese (BMI ≥ 35) controlsRoux-en-Y gastric bypass patients

Eligibility Criteria

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

Morbid obesity subjects (n=40) will be recruited at the bariatric outpatient clinic of the department of Surgery at University Hospital Zurich during one of their preoperative visits. The lean control group (n=20) will be recruited by internal advertisement to students and employees.

You may qualify if:

  • Adult aged \>18;
  • Obese and non-obese group:
  • Obese person BMI \> 35 kg/m2 with no history of bariatric surgery;
  • Healthy normal weight controls (BMI \< 25 kg/m2) with no history of bariatric surgery.
  • Independently mobile;
  • Digital literacy;
  • Ability to communicate fluently in German;
  • Capacity to consent to participate;

You may not qualify if:

  • Diabetes;
  • Pregnancy/lactation;
  • Inability to understand instructions;
  • Systemic or gastrointestinal condition which may affect food intake or preference;
  • Diabetes Mellitus (type I and II);
  • Pregnancy or lactation ;
  • Weight loss diet or weight gain diet;
  • Active and significant psychiatric illness including substance misuse;
  • Suffering from heart or kidney failure or malabsorption;
  • Significant cognitive or communication issues;
  • Medications with documented effect on food intake or food preference;
  • History of significant food allergy and certain dietary restrictions;
  • Participants who have travelled (overnight trip of more than 200 miles) within 2 weeks before or after dose administration of isotopes;
  • Participants that need to have intravenous fluids during 2 weeks before and after the study period will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (20)

  • Mathes CM, Spector AC. Food selection and taste changes in humans after Roux-en-Y gastric bypass surgery: a direct-measures approach. Physiol Behav. 2012 Nov 5;107(4):476-83. doi: 10.1016/j.physbeh.2012.02.013. Epub 2012 Feb 16.

    PMID: 22366157BACKGROUND
  • Mathes CM, Letourneau C, Blonde GD, le Roux CW, Spector AC. Roux-en-Y gastric bypass in rats progressively decreases the proportion of fat calories selected from a palatable cafeteria diet. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R952-9. doi: 10.1152/ajpregu.00444.2015. Epub 2016 Feb 10.

    PMID: 26864811BACKGROUND
  • Bueter M, Miras AD, Chichger H, Fenske W, Ghatei MA, Bloom SR, Unwin RJ, Lutz TA, Spector AC, le Roux CW. Alterations of sucrose preference after Roux-en-Y gastric bypass. Physiol Behav. 2011 Oct 24;104(5):709-21. doi: 10.1016/j.physbeh.2011.07.025. Epub 2011 Jul 30.

    PMID: 21827777BACKGROUND
  • le Roux CW, Bueter M, Theis N, Werling M, Ashrafian H, Lowenstein C, Athanasiou T, Bloom SR, Spector AC, Olbers T, Lutz TA. Gastric bypass reduces fat intake and preference. Am J Physiol Regul Integr Comp Physiol. 2011 Oct;301(4):R1057-66. doi: 10.1152/ajpregu.00139.2011. Epub 2011 Jul 6.

    PMID: 21734019BACKGROUND
  • Miras AD, Seyfried F, Phinikaridou A, Andia ME, Christakis I, Spector AC, Botnar RM, le Roux CW. Rats fed diets with different energy contribution from fat do not differ in adiposity. Obes Facts. 2014;7(5):302-10. doi: 10.1159/000368622. Epub 2014 Oct 1.

    PMID: 25277969BACKGROUND
  • Mathes CM, Bohnenkamp RA, Blonde GD, Letourneau C, Corteville C, Bueter M, Lutz TA, le Roux CW, Spector AC. Gastric bypass in rats does not decrease appetitive behavior towards sweet or fatty fluids despite blunting preferential intake of sugar and fat. Physiol Behav. 2015 Apr 1;142:179-88. doi: 10.1016/j.physbeh.2015.02.004. Epub 2015 Feb 3.

    PMID: 25660341BACKGROUND
  • Mathes CM, Bohnenkamp RA, le Roux CW, Spector AC. Reduced sweet and fatty fluid intake after Roux-en-Y gastric bypass in rats is dependent on experience without change in stimulus motivational potency. Am J Physiol Regul Integr Comp Physiol. 2015 Oct 15;309(8):R864-74. doi: 10.1152/ajpregu.00029.2015. Epub 2015 Aug 19.

    PMID: 26290100BACKGROUND
  • Mathes CM, Bueter M, Smith KR, Lutz TA, le Roux CW, Spector AC. Roux-en-Y gastric bypass in rats increases sucrose taste-related motivated behavior independent of pharmacological GLP-1-receptor modulation. Am J Physiol Regul Integr Comp Physiol. 2012 Mar 15;302(6):R751-67. doi: 10.1152/ajpregu.00214.2011. Epub 2011 Dec 14.

    PMID: 22170618BACKGROUND
  • Seyfried F, Miras AD, Bueter M, Prechtl CG, Spector AC, le Roux CW. Effects of preoperative exposure to a high-fat versus a low-fat diet on ingestive behavior after gastric bypass surgery in rats. Surg Endosc. 2013 Nov;27(11):4192-201. doi: 10.1007/s00464-013-3020-6. Epub 2013 May 30.

    PMID: 23719976BACKGROUND
  • Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.

    PMID: 22836034BACKGROUND
  • Miras AD, le Roux CW. Mechanisms underlying weight loss after bariatric surgery. Nat Rev Gastroenterol Hepatol. 2013 Oct;10(10):575-84. doi: 10.1038/nrgastro.2013.119. Epub 2013 Jul 9.

    PMID: 23835488BACKGROUND
  • Behary P, Miras AD. Food preferences and underlying mechanisms after bariatric surgery. Proc Nutr Soc. 2015 Nov;74(4):419-25. doi: 10.1017/S0029665115002074. Epub 2015 May 20.

    PMID: 25990312BACKGROUND
  • Elmadfa I, Meyer AL. Developing suitable methods of nutritional status assessment: a continuous challenge. Adv Nutr. 2014 Sep;5(5):590S-598S. doi: 10.3945/an.113.005330.

    PMID: 25469404BACKGROUND
  • Martin CK, Nicklas T, Gunturk B, Correa JB, Allen HR, Champagne C. Measuring food intake with digital photography. J Hum Nutr Diet. 2014 Jan;27 Suppl 1(0 1):72-81. doi: 10.1111/jhn.12014. Epub 2013 Jul 15.

    PMID: 23848588BACKGROUND
  • Zhang W, Yu Q, Siddiquie B, Divakaran A, Sawhney H. "Snap-n-Eat": Food Recognition and Nutrition Estimation on a Smartphone. J Diabetes Sci Technol. 2015 May;9(3):525-33. doi: 10.1177/1932296815582222. Epub 2015 Apr 21.

    PMID: 25901024BACKGROUND
  • Schoeller DA, Ravussin E, Schutz Y, Acheson KJ, Baertschi P, Jequier E. Energy expenditure by doubly labeled water: validation in humans and proposed calculation. Am J Physiol. 1986 May;250(5 Pt 2):R823-30. doi: 10.1152/ajpregu.1986.250.5.R823.

    PMID: 3085521BACKGROUND
  • Schoeller DA. Measurement of energy expenditure in free-living humans by using doubly labeled water. J Nutr. 1988 Nov;118(11):1278-89. doi: 10.1093/jn/118.11.1278.

    PMID: 3142975BACKGROUND
  • Boushey CJ, Spoden M, Delp EJ, Zhu F, Bosch M, Ahmad Z, Shvetsov YB, DeLany JP, Kerr DA. Reported Energy Intake Accuracy Compared to Doubly Labeled Water and Usability of the Mobile Food Record among Community Dwelling Adults. Nutrients. 2017 Mar 22;9(3):312. doi: 10.3390/nu9030312.

    PMID: 28327502BACKGROUND
  • Racette SB, Schoeller DA, Luke AH, Shay K, Hnilicka J, Kushner RF. Relative dilution spaces of 2H- and 18O-labeled water in humans. Am J Physiol. 1994 Oct;267(4 Pt 1):E585-90. doi: 10.1152/ajpendo.1994.267.4.E585.

    PMID: 7943308BACKGROUND
  • Serra M, Alceste D, Hauser F, Hulshof PJM, Meijer HAJ, Thalheimer A, Steinert RE, Gerber PA, Spector AC, Gero D, Bueter M. Assessing daily energy intake in adult women: validity of a food-recognition mobile application compared to doubly labelled water. Front Nutr. 2023 Sep 22;10:1255499. doi: 10.3389/fnut.2023.1255499. eCollection 2023.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples collected after ingestion of double labeled water (DLW).

MeSH Terms

Conditions

Obesity, MorbidFood Preferences

Interventions

Methods

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Marco Bueter, MD, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, PhD, Head of Bariatric Surgery

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 23, 2020

Study Start

June 1, 2019

Primary Completion

January 16, 2023

Study Completion

January 16, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations