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

Obesity Clinical Trial

— BrainFood  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04788836
• Other study ID #: BrainFood Part 2
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Food Preferences
• Obesity

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Lia Bally	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between food purchase patterns (i.e. HETI, GPQI, food groups, nutrition facts, Nutri-Score) and self-perceived quality of life	Quality of life will be assessed using on a scale from 1 (very bad) to 5 (very good)	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in energy intake	Energy intake in kilocalories (kcal)/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily carbohydrate intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily sugar intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily fibre intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily protein intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily fat intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily saturated fat intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily sodium intake	Dietary intake in milligram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily vegetable intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily wholegrain intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily fruit intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily dessert intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Other	Changes in daily meat intake	Dietary intake in gram/day based on Food Frequency Questionnaire	Pre-treatment until 5 years after start of obesity treatment
Primary	Changes in food purchase behaviour on the basis of the Healthy Trolley Index (HETI)	Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the HETI, an objective and validated, nutrient-based, healthy shopping scoring system.	Pre-treatment until 5 years after start of obesity treatment
Primary	Changes in food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)	Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the GPQI, an objective and validated, nutrient-based, healthy shopping scoring system.	Pre-treatment until 5 years after start of obesity treatment
Primary	Changes in food purchase behaviour on the basis of food groups	Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of food groups like vegetables, wholegrain, fruits, sweets and meats.	Pre-treatment until 5 years after start of obesity treatment
Primary	Changes in food purchase behaviour on the basis of nutrition facts	Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of nutrition facts like energy (kcal), carbohydrates, sugars, added sugars, protein, fat, saturated fat, dietary fibre and salt.	Pre-treatment until 5 years after start of obesity treatment
Primary	Changes in food purchase behaviour on the basis of the Nutri-Score	Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the Nutri-Score, representing the nutritional quality of products. The Nutri-Score is based on a discrete continuous scale from -15 (most healthy) to 40 (least healthy). The score is then transcribed into five colour categories (A-E, ranging from bright green (most healthy) to red (least healthy)).	Pre-treatment until 5 years after start of obesity treatment
Primary	Food purchase behaviour on the basis of the Healthy Trolley Index (HETI)	HETI will be compared between obesity treatment group and control group	Pre-treatment until 5 years after start of obesity treatment
Primary	Food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)	GPQI will be compared between obesity treatment group and control group	Pre-treatment until 5 years after start of obesity treatment
Primary	Food purchase behaviour on the basis of food groups	Food groups will be compared between obesity treatment group and control group	Pre-treatment until 5 years after start of obesity treatment
Primary	Food purchase behaviour on the basis of nutrition facts	Nutrition facts will be compared between obesity treatment group and control group	Pre-treatment until 5 years after start of obesity treatment
Primary	Food purchase behaviour on the basis of the Nutri-Score	Nutri-Score will be compared between obesity treatment group and control group	Pre-treatment until 5 years after start of obesity treatment