Actively Recruiting
Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women With Overweight or Obesity
Led by Max Planck Institute for Human Cognitive and Brain Sciences · Updated on 2026-03-30
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women during the perimenopausal transition who are living with overweight or obesity to see if a special diet can improve brain health. The study focuses on how changes in gut bacteria through diet might reduce inflammation in the brain, which is linked to cognitive decline and dementia risk. This trial aims to explore the effects of a fiber- and polyphenol-rich diet on brain inflammatory processes in this group of women. Participants will be randomly assigned to one of two groups for six months. One group will receive a personalized daily powder containing either 7.5g or 15g of inulin plus 200mg resveratrol and 320mg quercetin, taken with main meals in the first half of the day. The other group will get an equal-calorie placebo powder made of maltodextrin. The dose of inulin is chosen based on each participant's gut microbiome at the study start. Throughout the study, women will have brain MRI scans before and after the 26-week intervention to assess inflammation-related brain markers. They will also undergo neuropsychological tests, body measurements, and complete questionnaires. Blood and stool samples will be collected for analysis of gut bacteria and metabolites. Researchers will measure changes in brain inflammation, blood-brain barrier function, and memory. The primary outcome is a brain white matter inflammation marker measured by diffusion-weighted MRI.
CONDITIONS
Brief Title
Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 35 to 60 years
- Perimenopausal status defined as STRAW+10 -1 or -2
- Body mass index (BMI) greater than 25 or waist-to-hip ratio of 0.85 or higher
- High sensitivity C-reactive protein (hsCRP) level above 1 mg/l
- No contraindications for magnetic resonance imaging (MRI)
- Provided written informed consent
You will not qualify if you...
- Clinically relevant psychiatric disease in the past 12 months (depression, substance abuse, eating disorder, schizophrenia)
- Type 1 diabetes
- Previous bariatric or gastric surgery
- Currently pregnant or breastfeeding
- Severe untreated diseases, cancer treatment within the last 12 months, chronic gastric tract diseases or chronic inflammatory diseases
- Polycystic ovary syndrome or total ovary removal
- Antibiotic use in the past 3 months
- Use of inulin over 5g/day or polyphenol supplementation over 50mg/day in the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants follow a fiber- and polyphenol-rich dietary supplement regimen daily for 6 months, with dosage personalized based on their microbiome composition at baseline or receive a placebo supplement.
Monthly visits for monitoring and assessments
Trial Site Locations
Total: 1 location
1
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, Germany, 04103
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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