Six-month high-fiber, high-polyphenol diet to lower brain inflammation in perimenopausal women with overweight or obesity
Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | Female |
| Sponsor | Max Planck Institute for Human Cognitive and Brain Sciences Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT07501377 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leipzig, Saxony
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.