An interventional study of Polybiotic dietary intervention and Placebo in Overweight and/or Obesity and Perimenopausal Women, sponsored by Max Planck Institute for Human Cognitive and Brain Sciences. Recruiting at 1 site in Germany. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Max Planck Institute for Human Cognitive and Brain Sciences · Not applicable, Interventional, and Basic science
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.
150 studies on the registry are indexed under Neuroinflammatory Diseases; 70 are open to participants now.
This study's planned enrollment of 120 is above the median of 44 across 91 interventional studies indexed under Neuroinflammatory Diseases.
Browse Neuroinflammatory Diseases studies →Max Planck Institute for Human Cognitive and Brain Sciences is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Polybiotic dietary intervention
Daily intake of equicaloric maltodextrin
Dietary Supplement: Placebo
7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula
Equicaloric maltodextrin in powder form
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
Time frame: 6 months
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).
Time frame: 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)
Time frame: 6 months
Hypothalamic and hippocampal microstructure
microstructure will be assessed by mean diffusivity (MD)
Time frame: 6 months
Episodic memory
California Verbal Learning Task
Time frame: 6 months
Microbial Composition
Alpha/Beta diversity and abundance of specific bacteria (e.g. bifidobacteria) from microbiome shotgun sequencing
Time frame: 6 months
soma signal fraction in thalamus and hippocampus derived from multi-shell diffusion-weighted MRI
assessed using multi-shell diffusion-weighted MRI at 3T
Time frame: 6 months
Pattern separation
Dprime and accuracy, reaction time of Mnemonic Similarity Task (MST)
Time frame: 6 months
Executive function
Composite score of executive function tests derived from Trail Making Test, Attention Network Test, Stroop-Test
Time frame: 6 months
pro-inflammatory marker high-sensitive C-reactive protein (hsCRP)
hsCRP measured in fasting blood
Time frame: 6 months
waist-to-hip ratio, WHR
ratio of waist circumeference to hip circumference (measured)
Time frame: 6 months
Adherence to healthy dietary pattern
A composite score based on self-reported information provided through diet protocol and food frequency questionnaire (FFQ)
Time frame: 6 months
Menopausal symptoms
severity of menopausal symptoms based on a questionnaire
Time frame: 6 months
Assessment of health data
via wearables - smart devices finger ring and/or watch and glucose patch
Time frame: 6 months (during 2 weeks at baseline, and follow-up, respectively)
Demographics, anamnesis
Age, sex/gender, medical history, reproductive history, medication
Time frame: 6 months
Total energy expenditure measured using a metabolic chamber
Oxygen consumption and CO2 production measured in a metabolic chamber, determining 24-hour total energy expenditure (TEE)
Time frame: 6 months
body fat percentage
measured using bioelectrical impedance analysis (BIA)
Time frame: 6 months
Gastrointestinal hormones
area under the curve (pre- to postprandial) of glukagon-like peptide 1 (GLP-1)
Time frame: 6 months
Sex hormones
Follicle-stimulating hormon (FSH) measured in blood
Time frame: 6 months
Plan to share: Undecided
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Max Planck Institute for Human Cognitive and Brain Sciences