What this trial studies
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.
Conditions in scope
- Overweight and/or Obesity
- Perimenopausal Women
Interventions
- Polybiotic dietary intervention (Dietary Supplement) — 7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula
- Placebo (Dietary Supplement) — Equicaloric maltodextrin in powder form
Who can join
Women only · Ages 35 Years to 60 Years · Accepts healthy volunteers.
Inclusion criteria
- STRAW+10 -1 or -2
- BMI \> 25 or WHR \>= 0.85
- hsCRP \> 1 mg/l
- no MRI contra-indication
- written informed consent
Exclusion criteria
- 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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Leipzig | Saxony | Max Planck Institute for Human Cognitive and Brain Sciences | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2026-03-19
- Primary completion: 2029-06-30
- Last update posted: 2026-03-30
- First posted: 2026-03-30
Sponsor & contact
Lead sponsor: Max Planck Institute for Human Cognitive and Brain Sciences (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Free water fraction averaged across the white matter skeleton (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
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07501377 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.