Six-month high-fiber, high-polyphenol diet to lower brain inflammation in perimenopausal women with overweight or obesity
Official title: Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity
Run by Max Planck Institute for Human Cognitive and Brain Sciences · NCT07501377 · Data updated 2026-11-12
This will try a 6-month high-fiber, high-polyphenol (polybiotic) diet to see if it lowers brain inflammation in perimenopausal women with overweight or obesity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 60 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Max Planck Institute for Human Cognitive and Brain Sciences Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07501377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Perimenopausal women with BMI > 25 or waist–hip ratio ≥ 0.85, hsCRP > 1 mg/L, able to undergo MRI, and willing to follow the dietary program and provide samples are ideal candidates.
✕Probably not a fit
People who are not perimenopausal, have BMI < 25, have chronic inflammatory or severe gastrointestinal diseases, recent antibiotic use, recent bariatric surgery, or other listed exclusions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Perimenopausal women with overweight or obesity and elevated inflammation will follow a 6-month dietary intervention rich in fiber and polyphenols (polybiotic) or a placebo control. The trial collects blood markers of inflammation (including hsCRP), stool samples to track microbiome changes, and brain MRI measures related to neuroinflammation at baseline and after the intervention. Participants must meet menopause transition and body composition thresholds and have no MRI contraindications or recent antibiotic or relevant supplement use. The protocol aims to link diet-driven microbiome shifts to changes in systemic and brain inflammatory signals over six months.
Why it matters
Potential benefit: If successful, this approach could reduce brain inflammation and potentially lower future risk of cognitive decline in perimenopausal women with excess weight.
How similar studies have gone: Previous observational and small interventional studies suggest diet and microbiome changes can reduce systemic inflammation, but robust human data specifically linking fiber/polyphenol diets to reduced brain inflammation in this population remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, Germany Recruiting
Study contacts
- Principal investigator: Veronica Witte, PhD — University of Leipzig Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.