Overweight and/or ObesityINFLAMENCT07501377
Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity
A study testing Polybiotic dietary intervention in people with Overweight and/or Obesity and Perimenopausal Women, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
Trial summary
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity, Perimenopausal Women
- What is being tested?
- Polybiotic dietary intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2026to 31 Dec 2030
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- STRAW+10 -1 or -2
- BMI > 25 or WHR >= 0.85
- hsCRP > 1 mg/l
- no MRI contra-indication
- written informed consent
Who cannot join
- occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)
- type 1 diabetes
- previous bariatric/gastric surgery
- pregnancy or breastfeeding woman
- severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease
- Polycystic ovary syndrome, total ovarectomy
- Intake of antibiotics in past 3 months, intake of inulin (>5g/day) or polyphenol supplementation (>50mg/day) in past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, 04103
Omegalab, +49 341 9940-2417, in-flame@cbs.mpg.de
About this study
Official title: Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes.
Recent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health.
Read more
Specifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce.
This randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized "polybiotic" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight/obesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric/gastrointestinal disorders, and magentic resonance imaging (MRI) contraindications.
Before and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models.
This study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.
- Conditions
- Overweight and/or Obesity, Perimenopausal Women
- Being tested
- Polybiotic dietary intervention, Placebo
- Keywords
- neuroinflammation, obesity, overweight, menopausal transition, gut-brain axis, diet, diffusion-weighted MRI, cognitive decline, brain aging, MR spectroscopy, prevention, open science
- Medical subject headings
- Neuroinflammatory Diseases, Obesity, Overweight, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polybiotic dietary interventionDietary supplement
7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula
PlaceboDietary supplement
Equicaloric maltodextrin in powder form
| Study group | Role | What they receive |
|---|---|---|
| Personalized intervention arm | Experimental | Daily intake of 7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula with main meals in the first half of day, over the course of 6 months. The lower or higher inulin dosage will be assigned depending on the participants' microbiome composition at baseline. Receives: Dietary Supplement: Polybiotic dietary intervention |
| Placebo arm | Placebo comparator | Daily intake of equicaloric maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free water fraction averaged across the white matter skeleton
Free water (measured using multi-shell diffusion-weighted MRI at 3 Tesla) reflects extra-cellular water which can be considered an indicator of tissue edema and impaired blood brain barrier
Measured: 6 months
Secondary outcomes (5)
Average grey matter kw from motion-compensated diffusion-weighted arterial spin labeling (ASL)
Water exchange rate over the blood-brain barrier will be measured using motion-compensated diffusion-weighted pseudo-continuous arterial-spin labeling (MCDW-ASL) or diffusion-prepared pCASL (DP-pCASL).
Measured: 6 months
Apparent diffusion coefficient of metabolites in the thalamus from diffusion-weighted MR spectoscropy
microglial activity will be quantified by measuring ADCCholine using diffusion-weighted magnetic resonance spectroscopy (dwMRS)
Measured: 6 months
Hypothalamic and hippocampal microstructure
microstructure will be assessed by mean diffusivity (MD)
Measured: 6 months
Episodic memory
California Verbal Learning Task
Measured: 6 months
Microbial Composition
Alpha/Beta diversity and abundance of specific bacteria (e.g. bifidobacteria) from microbiome shotgun sequencing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start19 Mar 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronica Witte, PhD, Principal investigator, University of Leipzig Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501377
- Sponsor's protocol ID
- NRO-286
- Acronym
- INFLAME
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity
- ClinicalTrials.gov ID
- NCT07501377
- Acronym / sponsor ID
- INFLAME / NRO-286
- Conditions
- Overweight and/or Obesity, Perimenopausal Women
- Keywords
- neuroinflammation, obesity, overweight, menopausal transition, gut-brain axis, diet, diffusion-weighted MRI, cognitive decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain SciencesUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes.
Recent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health.
Specifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce.
This randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized "polybiotic" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight/obesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric/gastrointestinal disorders, and magentic resonance imaging (MRI) contraindications.
Before and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models.
This study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized intervention arm | Experimental | Dietary Supplement: Polybiotic dietary interventionDaily intake of 7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula with main meals in the first half of day, over the course of 6 months. The lower or higher inulin dosage will be assigned depending on the participants' microbiome composition at baseline. |
| Placebo arm | Placebo comparator | Dietary Supplement: PlaceboDaily intake of equicaloric maltodextrin |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- STRAW+10 -1 or -2
- BMI > 25 or WHR >= 0.85
- hsCRP > 1 mg/l
- no MRI contra-indication
- written informed consent
Key exclusion criteria (7 listed)
- occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)
- type 1 diabetes
- previous bariatric/gastric surgery
- pregnancy or breastfeeding woman
- severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polybiotic dietary intervention7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula | Dietary supplement | Personalized intervention arm |
| PlaceboEquicaloric maltodextrin in powder form | Dietary supplement | Placebo arm |
Primary outcome
Free water fraction averaged across the white matter skeleton
Time frame: 6 months
Free water (measured using multi-shell diffusion-weighted MRI at 3 Tesla) reflects extra-cellular water which can be considered an indicator of tissue edema and impaired blood brain barrier
5 secondary outcomes
Average grey matter kw from motion-compensated diffusion-weighted arterial spin labeling (ASL)
Time frame: 6 months
Apparent diffusion coefficient of metabolites in the thalamus from diffusion-weighted MR spectoscropy
Time frame: 6 months
Hypothalamic and hippocampal microstructure
Time frame: 6 months
Episodic memory
Time frame: 6 months
Microbial Composition
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight and/or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Germany
Veronica Witte, PhD principal investigator
University of Leipzig Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polybiotic dietary intervention in people with Overweight and/or Obesity and Perimenopausal Women, 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 5 inclusion and 7 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 30 Mar 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free water fraction averaged across the white matter skeleton (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.