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Impact of Microbiome-changing Interventions on Food Decision-making

NCT ID: NCT05353504

Last Updated: 2022-04-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2026-12-31

Brief Summary

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The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention/control period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3/V4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
People will be randomly assigned to the three arms and blinded towards receipt of dietary fibre supplement or placebo supplement. However, behavioural lifestyle intervention arm cannot be blinded to participants.

Study Groups

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prebiotic dietary supplement

high-dose daily inulin

Group Type ACTIVE_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

28g/day delivered in 2 sachets throughout the day with main meals

behavioural lifestyle intervention

new educational program to change eating behaviour, provided through weekly sessions.

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

weekly educational sessions to improve individual's eating behaviour

placebo dietary supplement

equicaloric daily maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

Interventions

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Inulin

28g/day delivered in 2 sachets throughout the day with main meals

Intervention Type DIETARY_SUPPLEMENT

Lifestyle intervention

weekly educational sessions to improve individual's eating behaviour

Intervention Type BEHAVIORAL

Placebo

equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f)
* no MRI contra-indication
* written informed consent

Exclusion Criteria

* athletes
* occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia
* any chronic inflammatory or malignant disease
* type 1 diabetes
* previous bariatric/gastric surgery
* pregnancy or breastfeeding woman
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Leipzig

OTHER

Sponsor Role collaborator

DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)

UNKNOWN

Sponsor Role collaborator

Helmholtz-Zentrum für Umweltforschung - UFZ

UNKNOWN

Sponsor Role collaborator

Max Planck Institute for Human Cognitive and Brain Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Witte, PhD

Role: PRINCIPAL_INVESTIGATOR

Cognitive Neurology, University Medical Center Leipzig

Locations

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Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Meghedi Vartanian, MSc

Role: CONTACT

Phone: +49(0)341/9940-951

Email: [email protected]

Facility Contacts

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Meghedi Vartanian, Msc

Role: primary

Silke Friedrich

Role: backup

References

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Vartanian M, Endres KJ, Lee YT, Friedrich S, Meemken MT, Schamarek I, Rohde-Zimmermann K, Schurfeld R, Eisenberg L, Hilbert A, Beyer F, Stumvoll M, Sacher J, Villringer A, Christensen JF, Witte AV. Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol. BMC Nutr. 2025 Jan 13;11(1):8. doi: 10.1186/s40795-024-00971-6.

Reference Type DERIVED
PMID: 39806493 (View on PubMed)

Other Identifiers

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MIFOOD

Identifier Type: -

Identifier Source: org_study_id