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Overweight and ObesityMIFOODNCT05353504

Impact of Microbiome-changing Interventions on Food Decision-making

A study testing Inulin and Lifestyle intervention in people with Overweight and Obesity, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Inulin and Lifestyle intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteGermany
Study dates
8 Mar 2022to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meghedi Vartanian, MSc contact

+49(0)341/9940-951

mi-food@cbs.mpg.de

Germany1 site, 1 recruiting

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

    Leipzig

    Meghedi Vartanian, Msc, +49(0)341/9940-954, mi-food@cbs.mpg.de

    Silke Friedrich, +49(0)341/9940-954, mi-food@cbs.mpg.de

    Recruiting

Other trials in Germany

About this study

Official title: "SFB 1052/3 - Mechanismen Der Adipositas, Projekt A1: Veränderung Der Neurobiologischen Grundlagen Von Ess-Entscheidungen Bei Adipositas" Engl. "CRC 1052/3 - Obesity Mechanisms, Project A1: Targeting Neurobehavioral Determinants of Obesity"

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.

Being tested
Inulin, Lifestyle intervention, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InulinDietary supplement

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

  • Lifestyle interventionBehavioural

    weekly educational sessions to improve individual's eating behaviour

  • PlaceboDietary supplement

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

Study groups in NCT05353504
Study groupRoleWhat they receive
prebiotic dietary supplementActive comparatorhigh-dose daily inulin
Receives: Dietary Supplement: Inulin
behavioural lifestyle interventionExperimentalnew educational program to change eating behaviour, provided through weekly sessions.
Receives: Behavioral: Lifestyle intervention
placebo dietary supplementPlacebo comparatorequicaloric daily maltodextrin
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood-oxygenation-level-dependent (BOLD) activity during food wanting

    BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting task according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Wanting rating scores (on an 8-point likert scale) per stimulus will be added as covariates. In a parallel model, kcal of food stimuli will be added multiplied with wanting scores to model high caloric food wanting interaction. At the group level, we will assess the contrasts food > art and wanting modulation.

    Measured: 6 months

Secondary outcomes (16)

  1. microbial alpha and beta diversity

    Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples

    Measured: 6 months

  2. fMRI BOLD activity memory performance

    BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting and food memory recognition tasks according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation in encoding and recognition will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Correctly remembered and correctly rejected, as well as misses and false alarms will be modeled separately. In parallel models, similar and new items als well as wanting rating scores (on an 8-point likert scale) per stimulus and kcal of food stimuli multiplied with wanting scores will be added as covariates. At the group level, we will assess the contrasts correct > false and wanting modulation.

    Measured: 6 months

  3. satiety

    self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).

    Measured: 6 months

  4. ghrelin

    ghrelin pg/ml in blood

    Measured: 6 months

  5. leptin

    leptin ng/ml in blood

    Measured: 6 months

  6. GLP-1

    Glucagon-like peptide-1 (GLP-1) pg/ml in blood

    Measured: 6 months

  7. PYY

    peptide YY pg/ml in blood

    Measured: 6 months

  8. insulin

    insulin in blood uU/ml

    Measured: 6 months

  9. HbA1c

    hemoglycated globulin A1c in blood %

    Measured: 6 months

  10. inflammatory markers

    high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)

    Measured: 6 months

  11. microbial metabolic markers in blood

    short-chain fatty acids (SCFA), bile acids

    Measured: 6 months

  12. body mass index

    weight kg/height in m squared

    Measured: 6 months

  13. waist hip ratio

    waist (cm) to hip (cm) circumeference ratio

    Measured: 6 months

  14. body fat

    body fat % according to bioelectrical impedance analysis

    Measured: 6 months

  15. food craving

    assessed with the food craving questionnaire (Meule et al., 2012, German version).

    Measured: 6 months

  16. executive attention performance

    measured using the attention network task (ANT)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start8 Mar 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353504
Sponsor's protocol ID
MIFOOD
Acronym
MIFOOD
Status last verified
Apr 2022
First submitted
23 Mar 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share all data openly but anonymized on secured German servers of the institute after registration with ID.

Publications

  • 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.

    PubMed 39806493

Questions about this trial

What is this clinical trial studying?

A study testing Inulin and Lifestyle intervention in people with Overweight and Obesity, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meghedi Vartanian, MSc (+49(0)341/9940-951, mi-food@cbs.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood-oxygenation-level-dependent (BOLD) activity during food wanting (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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