How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)

NCT ID: NCT04788836

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-12-31

Brief Summary

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Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract remarkably alters metabolism and hormones acting on neurological and hypothalamic signalling, involved in food decision-making and eating behaviour. In this context, many patients who underwent bariatric surgery self-report changes in appetite, satiety and food preferences. Furthermore, new gut hormone-based (e.g. GLP-1 receptor agonist or GLP-1-RA) pharmacotherapies which mimic the effect of bariatric surgery show impressive efficacy on weight reduction by modulation of food behaviour. However, the mechanisms of such functional changes, and how they relate to food decision-making and food purchase behaviour remain unknown.

In Part 2 of the BrainFood-project, the investigators propose a novel approach using digital receipts from loyalty card to unravel the effect of obesity treatments (surgical and non-surgical) on eating and food purchase behaviour in daily life.

Detailed Description

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The overall aim of this project is to elucidate the changes in food behaviour among obese adults undergoing obesity treatments.

The main objective is to observe the effect of obesity treatments on food purchase behaviour using digital receipts from grocery shopping. The investigators hypothesize that bariatric surgery leads to changes in food purchase behaviour in obese adults.

The further objective is to compare food purchase behaviour between obese adults against values of an existing reference population, and to assess whether these differences tend to be reduced after the start of the treatment among obese participants.

Conditions

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Food Preferences Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Obesity treatment Group

60 (minimum) to 150 (maximum) overweight/obese adults referred for or who started obesity (surgical or non-surgical) treatment within 6 months

Questionnaire (Survey and Food Frequency Questionnaire (FFQ))

Intervention Type OTHER

Each participant will be asked to fill a web-based questionnaire that captures sociodemographic, lifestyle, physical and mental health information (Survey) and dietary intake patterns (FFQ). This will be done pre-treatment (only for those included pre-treatment), 6 months after the start of obesity treatment, 1 year after the start of the treatment and then yearly until 5 year after the start of the treatment.

Collection of digital receipts from grocery shopping

Intervention Type OTHER

Participants will create their BitsaboutMe-account (GDPR-compliant data sharing platform from Bern, Switzerland) with the help of study team members. Data from digital receipts will be obtained from Migros Cumulus and Coop Supercard via their BitsaboutMe-account. The data collection allow retrospective digital receipts collection for up to 2 years and automatically continuous collection during study duration.

GDPR: General Data Protection Regulation

Control Group

Comparison of food purchase behaviour with control subjects will be performed using an already existing cohort from a previous study. This does not required recruiting control subjects.

No interventions assigned to this group

Interventions

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Questionnaire (Survey and Food Frequency Questionnaire (FFQ))

Each participant will be asked to fill a web-based questionnaire that captures sociodemographic, lifestyle, physical and mental health information (Survey) and dietary intake patterns (FFQ). This will be done pre-treatment (only for those included pre-treatment), 6 months after the start of obesity treatment, 1 year after the start of the treatment and then yearly until 5 year after the start of the treatment.

Intervention Type OTHER

Collection of digital receipts from grocery shopping

Participants will create their BitsaboutMe-account (GDPR-compliant data sharing platform from Bern, Switzerland) with the help of study team members. Data from digital receipts will be obtained from Migros Cumulus and Coop Supercard via their BitsaboutMe-account. The data collection allow retrospective digital receipts collection for up to 2 years and automatically continuous collection during study duration.

GDPR: General Data Protection Regulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male subjects aged 18 years or older
* Proficient in German (including written)
* BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)
* Referred for obesity treatment or who started obesity treatment within 6 months (surgical or non-surgical)
* Primary grocery shopping at the Swiss biggest grocery retailers (Coop, Migros), and regularly using a loyalty card (Cumulus and/or Supercard)

Exclusion Criteria

* Incapacity to give informed consent
* Primary shopping in other food retailers (e.g. Aldi, Lidl, outside of Switzerland, etc.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

Lia Bally

OTHER

Sponsor Role lead

Responsible Party

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Lia Bally

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lia Bally, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bern & University of Bern

Locations

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Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BrainFood Part 2

Identifier Type: -

Identifier Source: org_study_id

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