Clinical trial NCT04933305: Microstructure of Ingestive Behavior and Body Weight Loss After Roux-en-Y Gastric Bypass
Official title: Correlation Between Microstructure of Ingestive Behavior and Body Weight Loss in Patients After Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Food Deprivation
Bariatric Surgery
Roux-en-y Gastric Bypass
Ingestive Microstructure
Ingestive Behavior
Drinkometer
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Dr. Alan Spector, Florida State University, Department of Psychology
First posted: 2021-06-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females with severe obesity that underwent RYGB

Brief summary: Studies of appetitive behavior in humans after RYGB have produced ambiguous results. It therefore remains unclear whether there are fundamental shifts in the palatability of high-fat and sugary foods after RYGB or simply a decrease in the appetitive drive to ingest them. Moreover, learning processes may play a role as changes in diet selection progress with time in rats after RYGB. However, direct measures of an altered food selection in humans after RYGB are rare and both the durability of the phenomenon as well as the role of experience for changes in food selection remain elusive.

Detailed description: Introduction Bariatric surgery (BS) is currently the most effective treatment of severe obesity. BS has a pleiotropic effect on the body, involving changes in basic metabolic rate, gut hormones and bile acid levels, intestinal nerve signaling and microbiota composition. Overall, patients report to eat less, to feel less hungry and they often change their food preferences. Initial insights on food intake and appetite can be provided by indirect measurements such as verbal report of energy intake, food diaries, and dietary recall questionnaires. However, indirect measurements are vulnerable to inaccuracy and, at best, only offer an estimate of the patients' real behavior. Such methodological limitations can be improved by complementing existing findings with direct measurements of eating and drinking. There are only very few studies to date that have applied direct measurements of ingestive behavior in BS patients. These studies focused mainly on macronutrient composition within a cafeteria diet and on some motivational aspects of appetitive behavior. This might be due to the fact that the assessment of the temporal organization of ingestive behavior within a meal in humans poses significant methodological and conceptual challenges to researchers and study design. The investigators have recently developed and validated a drinkometer for humans, which may have great utility in the investigation of the specific behavioral variables that underlie the altered appetite control in obesity, and also to specify neural effects of various medical or surgical weight-loss interventions.

The aim of this exploratory pilot study is to investigate a possible correlation between the microstructure of ingestive behavior and body weight loss in patients after Roux-en-Y gastric bypass with a follow-up of 5 years.

Methods Prospective observational study in patients that already received a RYGB. 50 patients will be recruited to consume a ready-to-drink, energy-dense oral nutritional supplement (product: Resource 2.0+fibre, Nestle, Vevey, Switzerland) in a food deprived state, until reaching satiety. The novel drinkometer will be used to measure ingestive microstructure and overall intake, and anthropometric parameters (weight, height) will be measured as well. Visual analogue scales will be used to assess self-reported hunger, thirst, fullness, liking, nausea, and pain. The participants will be asked to estimate their intake at the end of each session. The study visits will take place at each postoperative yearly control visit. Only for one subgroup of 30 patients, one year after surgery, one second study visit will be organised after an interval of two weeks from the first visit. In order to avoid sex-driven major differences in ingestive microstructure, only female participants will be included in the study.

Statistical analysis The drinkometer data will be processed and filtered by an in-house developed algorithm in Matlab 2017 software. Results will be analysed using descriptive statistics and statistical tests in RStudio software version 3.5.1.

Potential outcomes Any comprehensive understanding of how BS affects food intake requires a detailed analysis of the ingestive behavior itself, not simply the measurement of the outcome of the behavior. In other words, the information on how the food is consumed is equally or even more important than the information on how much food has been ingested. To the best of our knowledge, this is the first time that drinking microstructure in humans will be recorded and analyzed with a five-year follow-up in BS patients. Results will confirm if, in the long term, the microstructure of ingestive behavior might have a correlation with body weight loss or regain and hence be used as a predictor of surgery outcome. Further, this exploratory study may generate hypothesis on behavioral changes that occur following BS. Any treatment that affects total intake - e.g. BS - can be entirely viewed as function of its single components such as size and number of sucking bursts which then can provide relevant information e.g. on the motivational aspects of the ingestive behavior. The investigators expect to find at least two type of ingestive behaviours among study participants, one that would correlated with sustained body weight loss and one that would correlate with body weight regain.

Regardless of which outcomes are obtained, this innovative experiment will be a critical and a novel test of the explicit experience of humans with a high-sugar high-fat liquid meal after RYGB and its potential role for the understanding possible mechanisms determining postoperative outcomes, such as weight loss.

Eligibility criteria: Inclusion Criteria:

* received RYGB
* ability to provide inform consent

Exclusion Criteria:

* lactose intolerance
* diabetes
* immunosuppression
* pregnancy / lactation
* use of weight-loss medication
* history of previous visceral surgery

Primary outcomes:
measure: Correlation between microstructure of ingestive behavior and body weight loss
timeFrame: one year after surgery
Secondary outcomes:
measure: Stability of the microstructure of ingestive behavior
timeFrame: fourteen days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Marco Bueter, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1.
citation: Gero D, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x.
citation: 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.
citation: Spector AC, Klumpp PA, Kaplan JM. Analytical issues in the evaluation of food deprivation and sucrose concentration effects on the microstructure of licking behavior in the rat. Behav Neurosci. 1998 Jun;112(3):678-94. doi: 10.1037//0735-7044.112.3.678.
citation: Johnson AW. Characterizing ingestive behavior through licking microstructure: Underlying neurobiology and its use in the study of obesity in animal models. Int J Dev Neurosci. 2018 Feb;64:38-47. doi: 10.1016/j.ijdevneu.2017.06.012. Epub 2017 Jul 3.